Quality System

Today's Technician: Automotive Electricity and Electronics Classroom and Shop Manual Pack (Today's Technician: Automotive Electricity & Electronics)

2012-01-29T23:05:00.000-08:00

Today's Technician: Automotive Electricity and Electronics Classroom and Shop Manual Pack (Today's Technician: Automotive Electricity & Electronics)By Barry Hollembeak

Product Description

Unsurpassed in coverage of the theory and procedures for automotive electricity and electronics, the newest edition of this highly successful classroom and shop manual is guaranteed to instill both the knowledge and skills critical to success in the industry. TODAY'S TECHNICIAN: automotive electricity & ELECTRONICS, 5TH EDITION has been updated to offer a more streamlined presentation of diagnostic and service procedures, as well as additional attention to data bus networks, including the CAN, LIN, ISO, and other common systems. The book also features expanded coverage of vehicle accessory systems, including the new multi-stage air bag systems, weight classification systems, side air bag systems, and laser-guided cruise control systems. An all-new chapter on hybrid and high voltage systems rounds out the up-to-date content, ensuring readers gain a strong working knowledge that of the latest industry trends and technologies.

Supply Chain Management: A Logistics Perspective (with Student CD-ROM)

2012-01-29T22:56:00.000-08:00

Supply Chain Management: A Logistics Perspective (with Student CD-ROM)
By John J. Coyle, C. John Langley, Brian Gibson, Robert A. Novack, Edward J. Bardi

Product Description

The eighth edition continues to refine the focus from logistics to Supply Chain management. It provides new and updated "Supply Chain Profiles," vignettes at the beginning of each chapter that introduce students to the chapter's topics through familiar real-world companies, people, and events. The text demonstrates practical application of supply chain management through new and updated "On the Line" boxed features, which are applied examples that provide students with hands-on managerial experience of the chapter's topics. Revised and expanded "Supply Chain Technology" boxes throughout the text help students relate technological developments to Supply Chain management concepts and logistics practices. Students build their knowledge chapter by chapter through revised and expanded Short Cases at the end of each chapter.

#1 Delonghi TRD0715T Safe Heat Oil-Filled Radiator Low price

2012-01-29T01:44:00.000-08:00

#1 Delonghi TRD0715T Safe Heat Oil-Filled Radiator Low price

PRODUCT DESCRIPTION

Effectively heat any room of the house with the DeLonghi portable oil-filled radiator. The heater produces the maximum amount of radiant heat while ensuring a low surface temperature, making the radiator a nice choice for homes with pets or kids. The user-friendly control panel offers an adjustable thermostat and three heat settings to customize your heating needs and optimize energy-efficient operation. For added energy savings it also features a 24-hour programmable timer. With 96 settings you can heat a room for any amount of time and for different time periods during the day and night. The anti-freeze setting allows the unit to automatically turn itself on when the temperature drops below 44 degrees F. Safety highlights include rust-resistant durable metal construction, a gently rounded design, and a thermal cut-off function that automatically turns the heater off if it starts to overheat. With its sleek look and silent operation, the DeLonghi oil-filled radiator is the perfect solution to all your heating needs

7.3.4 Design and development review

2011-10-21T00:20:00.000-07:00

ISO9001:2008, Quality management systems — Requirements

7.3.4 Design and development review

At suitablestages, systematic reviews of design and development shall be performed inaccordance with planned arrangements (see 7.3.1)

a) toevaluate the ability of the results of design and development to meetrequirements, and

b) toidentify any problems and propose necessary actions.

Participantsin such reviews shall include representatives of functions concerned with thedesign and development stage(s) being reviewed. Records of the results of thereviews and any necessary actions shall be maintained (see

4.2.4).

NOTE These reviews are normally coordinated withthe design phases and include manufacturing process design and development.

7.3.4.1 Monitoring

Measurementsat specified stages of design and development shall be defined, analysed andreported with summary results as an input to management review.

NOTE These measurements include quality risks,costs, lead-times, critical paths and others, as appropriate.

7.3.3.2 Manufacturing process design output

2011-10-21T00:15:00.000-07:00

7.3.3.2 Manufacturing process design output

Themanufacturing process design output shall be expressed in terms that can beverified against manufacturing

processdesign input requirements and validated. The manufacturing process designoutput shall include

- specifications and drawings,

- manufacturing process flow chart/layout,

- manufacturing process FMEAs,

- control plan (see 7.5.1.1),

- work instructions,

- process approval acceptance criteria,

- data for quality, reliability,maintainability and measurability,

- results of error-proofing activities, asappropriate, and

- methods of rapid detection and feedback ofproduct/manufacturing process nonconformities.

7.3.3.1 Product design outputs — Supplemental

2011-10-21T00:13:00.000-07:00

7.3.3.1 Product design outputs — Supplemental

The productdesign output shall be expressed in terms that can be verified and validatedagainst product design input requirements. The product design output shallinclude

- design FMEA, reliability results,

- product special characteristics andspecifications,

- product error-proofing, as appropriate,

- product definition including drawings ormathematically based data,

- product design reviews results, and

- diagnostic guidelines where applicable.

7.3.3 Design and development outputs

2011-10-21T00:10:00.000-07:00

ISO9001:2008, Quality management systems — Requirements

7.3.3 Design and development outputs

The outputsof design and development shall be in a form suitable for verification againstthe design and development input and shall be approved prior to release.

Design anddevelopment outputs shall

a) meet theinput requirements for design and development,

b) provideappropriate information for purchasing, production and service provision,

c) containor reference product acceptance criteria, and

d) specifythe characteristics of the product that are essential for its safe and properuse.

NOTE Information for production and serviceprovision can include details for the preservation of product.

7.3.2 Design and development inputs

2011-10-20T02:12:00.000-07:00

ISO9001:2008, Quality management systems — Requirements

7.3.2 Design and development inputs

Inputsrelating to product requirements shall be determined and records maintained(see 4.2.4). These inputs shall include

a) functional and performance requirements,

b) applicable statutory and regulatory requirements,

c) where applicable, information derived fromprevious similar designs, and

d) otherrequirements essential for design and development.

The inputsshall be reviewed for adequacy. Requirements shall be complete, unambiguous andnot in conflict with each other.

NOTE Special characteristics (see 7.2.1.1) areincluded in this requirement.

7.3.2.1 Product design input

Theorganization shall identify, document and review the productdesign inputs requirements, including the following:

- customer requirements (contractreview) such as special characteristics (see 7.3.2.3), identification,traceability

andpackaging;

- use of information: the organizationshall have a process to deploy information gained from previous design

projects,competitor analysis, supplier feedback, internal input, field data, and otherrelevant sources, for

current andfuture projects of a similar nature;

- targets for product quality, life,reliability, durability, maintainability, timing and cost.

7.3.2.2 Manufacturing process design input

Theorganization shall identify, document and review themanufacturing process design input requirements,

including

- product design output data,

- targets for productivity, processcapability and cost,

- customers requirements, if any, and

- experience from previousdevelopments.

NOTE The manufacturing process design includesthe use of error-proofing methods to a degree appropriate to the magnitude ofthe problems and commensurate with the risks encountered.

7.3.2.3 Special characteristics

Theorganization shall identify special characteristics [see 7.3.3 d)] and

- include all special characteristicsin the control plan,

- comply with customer-specifieddefinitions and symbols, and

- identify process control documentsincluding drawings, FMEAs, control plans, and operator instructions with the customer’sspecial characteristic symbol or the organization’s equivalent symbol or notationto include those process steps that affect special characteristics.

NOTE Special characteristics can include product characteristics and processparameters

7.3 Design and development

2011-10-20T01:33:00.000-07:00

7.3 Design and development

NOTE The requirements of 7.3 include product andmanufacturing process design and development, and focus on error preventionrather than detection.

ISO9001:2008, Quality management systems — Requirements

7.3.1 Design and development planning

The organizationshall plan and control the design and development of product. During the designand development planning, the organization shall determine

a) thedesign and development stages,

b) thereview, verification and validation that are appropriate to each design anddevelopment stage, and

c) the responsibilities and authorities fordesign and development.

Theorganization shall manage the interfaces between different groups involved indesign and development to ensure effective communication and clear assignmentof responsibility.

Planningoutput shall be updated, as appropriate, as the design and developmentprogresses.

NOTE Designand development review, verification and validation have distinct purposes.They can be conducted and recorded separately or in any combination, assuitable for the product and the organization.

7.3.1.1 Multidisciplinary approach

Theorganization shall use a multidisciplinary approach to prepare for productrealization, including

- development/finalization andmonitoring of special characteristics,

- development and review of FMEAs,including actions to reduce potential risks, and

- development and review of controlplans.

NOTE Amultidisciplinary approach typically includes the organization's design, manufacturing, engineering, quality, production and other appropriatepersonnel

7.2.3 Customer communication

2011-10-18T18:46:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements

7.2.3 Customer communication

The organization shall determine and implement effective arrangements forcommunicating with customers in relation to

a) product information,

b) enquiries, contracts or order handling,including amendments, and

c) customer feedback, including customercomplaints.

7.2.3.1 Customer communication — Supplemental

The organization shall have the ability to communicate necessaryinformation, including data, in a customer specified language and format (e.g. computer-aided designdata, electronic data exchange).

7.2.2 Review of requirements related to the product

2011-10-18T18:44:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements

7.2.2 Review of requirements relatedto the product

The organizationshall review the requirements related to the product. This review shall beconducted prior to the organization's commitment to supply a product to thecustomer (e.g. submission of tenders,acceptance of contracts or orders,acceptance of changes to contracts or orders) and shall ensure that

a) product requirements aredefined,

b) contract or order requirementsdiffering from those previously expressed are resolved, and

c) the organization has the ability to meet the defined requirements.

Records of the results of the reviewand actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, thecustomer requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure thatrelevant documents are amended and that relevant personnel are made aware of the changedrequirements.

NOTE In some situations, such as internet sales,a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues oradvertizing material.

7.2.2.1 Review of requirementsrelated to the product — Supplemental

Waiving the requirement stated in7.2.2 for a formal review (see note) shall require customer authorization.

7.2.2.2 Organization manufacturing feasibility

The organization shallinvestigate, confirm and document the manufacturing feasibility of the proposedproducts in thecontract review process, including risk analysis.

7.2 Customer-related processes

2011-08-22T02:56:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
The organization shall determine
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements applicable to the product, and
d) any additional requirements considered necessary by the organization.
NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

NOTE 1 Post-delivery activities include any after-sales product service provided as part of the customer contract or purchase
order.
NOTE 2 This requirement includes recycling, environmental impact and characteristics identified as a result of the organization’s knowledge of the product and manufacturing processes (see 7.3.2.3).
NOTE 3 Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.

7.2.1.1 Customer-designated special characteristics The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.

7 Product realization

2011-08-19T02:46:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements

7 Product realization
7.1 Planning of product realization
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
The output of this planning shall be in a form suitable for the organization's method of operations.

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes
NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product realization. Advanced product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection, and is based on a multidisciplinary approach.

7.1.1 Planning of product realization — Supplemental
Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan.

7.1.2 Acceptance criteria
Acceptance criteria shall be defined by the organization and, where required, approved by the customer. For attribute data sampling, the acceptance level shall be zero defects (see 8.2.3.1).

7.1.3 Confidentiality
The organization shall ensure the confidentiality of customer-contracted products and projects under development, and related product information.

7.1.4 Change control
The organization shall have a process to control and react to changes that impact product realization. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation.For proprietary designs, impact on form, fit and function (including performance and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated. When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met.

NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer.

NOTE 2 The above requirement applies to product and manufacturing process changes.

6.4 Work environment

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ISO 9001:2008, Quality management systems — Requirements
6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
NOTE The term “work environment” relates to those conditions under which work is performed including physical,environmental and other factors (such as noise, temperature,humidity,lighting or weather).

6.4.1 Personnel safety to achieve product quality
Product safety and means to minimize potential risks to employees shall be addressed by the organization,especially in the design and development process and in manufacturing process activities.

6.4.2 Cleanliness of premises
The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs.

6.3 Infrastructure

2011-08-16T03:19:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements
6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport, communication or information systems).

6.3.1 Plant, facility and equipment planning
The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value-added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.

NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.

6.3.2 Contingency plans
The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns.

6.2.2 Competence, training and awareness

2011-08-15T01:03:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements
6.2.2 Competence, training and awareness
The organization shall
a) determine the necessary competence for personnel performing work affecting conformity to product requirements,
b) where applicable, provide training or take other actions achieve the necessary competence,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).

6.2.2.1 Product design skills
The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques. Applicable tools and techniques shall be identified by the organization.

6.2.2.2 Training
The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements.

NOTE 1 This applies to all employees having an effect on quality at all levels of the organization.
NOTE 2 An example of the customer specific requirements is the application of digitized mathematically based data.

6.2.2.3 Training on the job
The organization shall provide on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements.

6.2.2.4 Employee motivation and empowerment
The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.
The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives [see 6.2.2 d)].

6.2 Human resources

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ISO 9001:2008, Quality management systems — Requirements

6.2 Human resources
6.2.1 General
Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.

NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.

6 Resource management

2011-08-10T03:00:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements 6 Resource management

6.1 Provision of resources The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.

5.6.3 Review output

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ISO 9001:2008, Quality management systems — Requirements
5.6.3 Review output
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) ) improvement of product related to customer requirements, and
c) resource needs.

5.6.2 Review input

2011-08-08T02:57:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements

5.6.2 Review input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.

5.6.2.1 Review input — Supplemental
Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment.

5.6 Management review

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ISO 9001:2008, Quality management systems — Requirements

5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality
objectives.
Records from management reviews shall be maintained (see 4.2.4).

5.6.1.1 Quality management system performance
These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process.
Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1).
These results shall be recorded to provide, as a minimum, evidence of the achievement of
- the quality objectives specified in the business plan, and
- customer satisfaction with product supplied.

5.5.3 Internal communication

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ISO 9001:2008, Quality management systems — Requirements

5.5.3 Internal communication
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.

5.5.2 Management representative

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ISO 9001:2008, Quality management systems — Requirements

5.5.2 Management representative
Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
b) reporting to top management on the performance of the quality management system and any need for improvement, and
c) ensuring the promotion of awareness of customer requirements throughout the organization.
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.

5.5.2.1 Customer representative
Top management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development.

5.5 Responsibility, authority and communication

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ISO 9001:2008, Quality management systems — Requirements

5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.

5.5.1.1 Responsibility for quality Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements.
Personnel responsible for product quality shall have the authority to stop production to correct quality problems.
Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality.

5.4.2 Quality management system planning

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ISO 9001:2008, Quality management systems — Requirements

5.4.2 Quality management system planning
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.4 Planning

2011-08-02T03:00:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

5.4.1.1 Quality objectives — Supplemental
Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy.
NOTE Quality objectives should address customer expectations and be achievable within a defined time period.

5.3 Quality policy

2011-08-01T03:07:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements

5.3 Quality policy
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability.

5.2 Customer focus

2011-08-01T03:06:00.000-07:00

ISO 9001:2008, Quality management systems — Requirements

5.2 Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

5 Management responsibility

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ISO 9001:2008, Quality management systems — Requirements 5 Management responsibility

5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.

5.1.1 Process efficiency
Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency

4.2.4 Control of records

2011-07-27T03:02:00.000-07:00

ISO 9001:2008, Quality management system — Requirements
4.2.4 Control of records
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.
The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.
Records shall remain legible, readily identifiable and retrievable.

NOTE 1 “Disposition” above includes disposal.
NOTE 2 “Records” also include customer-specified records.

4.2.4.1 Records retention
The control of records shall satisfy regulatory and customer requirements.

4.2.3 Control of documents

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ISO 9001:2008, Quality management system — Requirements

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

4.2.3.1 Engineering specifications
The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer-required schedule. Timely review should be as soon as possible, and shall not exceed two working weeks.
The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents.

NOTE A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc

4.2.2 Quality manual

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ISO 9001:2008, Quality management system — Requirements

4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system,or reference to them, and
c) a description of the interaction between the processes of the quality management system.

4.2 Documentation requirements

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ISO 9001:2008, Quality management systems — Requirements

4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
a)documented statements of a quality policy and quality objectives,
b)a quality manual,
c)documented procedures and records required by this International Standard, and
d)documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a)the size of organization and type of activities,
b)the complexity of processes and their interactions, and
c)the competence of personnel.

NOTE 3 The documentation can be in any form or type of medium.

4 Quality management system

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ISO 9001:2008, Quality management systems — Requirements

4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall
a)determine the processes needed for the quality management system and their application throughout the organization (see 1.2),
b)determine the sequence and interaction of these processes,
c)determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d)ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e)monitor, measure where applicable, and analyse these processes, and
f)implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
NOTE 1 Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.
NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as
a)the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements,
b)the degree to which the control for the process is shared,
c)the capability of achieving the necessary control through the application of 7.4.

4.1.1 General requirements — Supplemental
Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customer requirements.
NOTE See also 7.4.1 and 7.4.1.3.

2 Normative references - 3.1.12

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2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 9000:2005, Quality management systems — Fundamentals and vocabulary

3 Terms and definitions
ISO 9001:2008, Quality management systems — Requirements
3 Terms and definitions
For the purposes of this Document, the terms and definitions given in ISO 9000 apply.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.

3.1 Terms and definitions for the automotive industry
For the purposes of this document, the terms and definitions given in ISO 9000:2005 and the following apply.
3.1.1
control plan
documented description of the systems and processes required for controlling product (see annex A)

3.1.2
design responsible organization
organization with authority to establish a new, or change an existing, product specification
NOTE This responsibility includes testing and verification of design performance within the customer’s specified application.

3.1.3
error proofing
product and manufacturing process design and development to prevent manufacture of nonconforming products

3.1.4
laboratory
facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical or reliability testing

3.1.5
laboratory scope
controlled document containing
- specific tests, evaluations and calibrations that a laboratory is qualified to perform,
- list of the equipment which it uses to perform the above, and
- list of methods and standards to which it performs the above

3.1.6
manufacturing
process of making or fabricating
- production materials,
- production or service parts,
- assemblies, or
- heat treating, welding, painting, plating or other finishing services

3.1.7
predictive maintenance
activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure
modes

3.1.8
preventive maintenance
planned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design

3.1.9
premium freight
extra costs or charges incurred additional to contracted delivery

NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc.

3.1.10
remote location
location that supports sites and at which non-production processes occur

3.1.11
site
location at which value-added manufacturing processes occur

3.1.12
special characteristic
product characteristic or manufacturing process parameter which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product

1.2 Application

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ISO 9001:2008, Quality management systems — Requirements
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability,or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.
Permitted exclusions do not include manufacturing process design.

Quality management systems

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Quality management systems — Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations

1 Scope

ISO 9001:2008, Quality management systems — Requirements 1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

NOTE 1 In this International Standard, the term “product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product realization processes.

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
This Technical Specification,in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.
This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.
Supporting functions, whether on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone certification to this Technical Specification.
This Technical Specification can be applied throughout the automotive supply chain.

0.5 Goal of this Technical Specification

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The goal of this Technical Specification is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.
This Technical Specification, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for those subscribing to this document.
This Technical Specification is intended to avoid multiple certification audits and provide a common approach to a quality management system for automotive production, and relevant service part organizations

0.4 Compatibility with other management systems

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ISO 9001:2008, Quality management systems — Requirements
0.4 Compatibility with other management systems
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community. Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004.
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.

0.3 Relationship with ISO 9004

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ISO 9001:2008, Quality management systems — Requirements
0.3 Relationship with ISO 9004
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.
At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of ISO 9004 will provide guidance to management for achieving sustained success for any organization in a complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement of the organization’s performance. However, it is not intended for certification, regulatory or contractual use.

NOTE The knowledge and use of the eight quality management principles referred to in ISO 9000:2005 and ISO 9004:2000 should be demonstrated and cascaded through the organization by top management

0.2 Process approach

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ISO 9001:2008, Quality management systems — Requirements
0.2 Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.

The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and
the organization's policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the product and
report the results.
Act: take actions to continually improve process performance.

Introduction ISO/TS16949:2009

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0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by
a)its organizational environment, changes in that environment,and the risks associated with that environment ,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard

What is ISO50001

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ISO 50001 is the new International Standard on Energy Management, proposed by ISO. This article gives a basic look into the need and expectations the proposed standard.

Energy efficiency and energy resource management is very relevant in today's context of global warming and climate change. Energy production is responsible for sixty percent of the worlds Green House Gas emissions. The proposed standard is in line with this requirement to help firms and organizations address and reference energy management issues on a global standard.

ISO 50001 is also proposed to be in line with ISO 9001 and ISO 14001 standards that address quality management and environmental management issues. Also, it will have the common elements of ISO's management standards like the continual improvement video Plan-Do-Check-Act method adopted in the earlier ISO Management standards.

Implementation of ISO 9001 means what the organization does to fulfill the customer's quality requirements,and applicable regulatory requirements, while aiming to enhance customer satisfaction,

Implementation of ISO 14001 means what the organization does to minimize harmful effects on the environment caused by its activities, and to achieve continual improvement of its environmental performance.

Similarly ISO 50001 implementation is expected to address what the organization does to effectively manage energy resources and performance that is relevant to global standards”.

Considering the fact that

•Energy production is the main contributor to GHG emissions.
•Energy efficiency is the quickest and cheapest way to reduce CO2 emissions
•Increased cost of Energy resources
•Reduced availability of fossil fuels and other basic sources of energy in the future.
an international standard was a along felt need. Combining technical and strategic management aspects are expected to give this standard wide acceptability.

The standard is expected to address issue like:

•measuring, reporting, benchmarking energy use improvements.
•assess energy improvement projects impact on GHG emissions.
•create transparency in the management of energy resources.
•evaluate the improvements in implementation of energy efficient technologies.
•validate continuous improvement in energy management.
•promoting a framework for efficient use of energy in the organization.
•helping organizations make a better use of their energy assets.
•helping in procurement practices for energy using equipment and systems.
•emphasis management's commitment to energy use and efficiency.
Initiated by Brazil and the US, ISO 50001 is scheduled to be released by end 2010. The standards are to be based on good practices and existing standards in various countries.

Good manufacturing practice

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"Good manufacturing practice" or "GMP" is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.

Although there are a number of them, all guidelines follow a few basic principles.

Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.
Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the drugs minimizes any risk to their quality.
A system is available for recalling any batch of drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.

What is New in ISO/TS16949:2009

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ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document:
an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote;
an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn.
ISO/TS 16949:2002 was prepared by the International Automotive Task Force (IATF), with support from ISO/TC 176, Quality management and quality assurance.
This third edition of ISO/TS 16949 cancels and replaces the second edition (ISO/TS 16949:2002), which has been technically amended according to ISO 9001:2008.
Boxed text is original ISO 9001:2008 text. The sector-specific supplemental requirements are outside the boxes.
In this Technical Specification, the word “shall” indicates a requirement. The word “should” indicates a recommendation. Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement.
Where the term “such as” is used, any suggestions given are for guidance only.
Annex A forms a normative part of this Technical Specification.
Remarks for certification
The certification to this Technical Specification, including customer-specific requirements if
any, is recognized by the customer members of IATF when achieved according to the IATF
certification scheme (see the “Rules for achieving IATF recognition”).

A.2 Elements of the control plan

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A.2 Elements of the control plan
The supplier shall develop a control plan that includes, as a minimum, the following contents.
a) General data
- control plan number,
- issue date, and revision date, if any,
- customer information (see customer requirements),
- supplier name/site designation,
- part number(s),
- part name/description,
- engineering change level,
- phase covered (prototype, pre launch, production),
- key contact,
- part/process step number,
- process name/operation description.
b) Product control
- product related special characteristics,
- other characteristics for control (number, product or process),
- specification/tolerance.
c) Process control
- process parameters,
- process related special characteristics,
- machines, jigs, fixtures, tools for manufacturing.
d) Methods
- evaluation measurement technique,
- error proofing,
- sample size and frequency,
- control method.
e) Reaction plan and corrective actions
- reaction plan (include or reference),
- corrective action.

Annex A (normative) Control plan (A.1)

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Annex A
(normative)
Control plan

A.1 Phases of the control plan
The control plan shall cover three distinct phases as appropriate.
a) Prototype: a description of the dimensional measurements, material and performance tests that will occur during building of the prototype. The supplier shall have a prototype control plan if required by the customer.
b) Pre launch: a description of the dimensional measurements, material and performance tests that occur after prototype and before full production. Pre launch is defined as a production phase in the process of product realization which may be required after prototype build.
c) Production: documentation of product/process characteristics, process controls, tests, and measurement systems that occur during mass production.
Each part shall have a control plan but, in many cases, family control plans may cover a number of similar parts produced using a common process. Control plans are an output of the quality plan.

Design responsible organization (3.1.3~3.1.13)

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3.1.3
design responsible organization
organization with authority to establish a new, or change an existing product specification for product delivered to a customer
NOTE This responsibility includes testing and verification of design performance within the customer's specified application.

3.1.4
error proofing
use of product and manufacturing process design and development features to prevent manufacture of non conforming products

3.1.5
laboratory
test facility that may include chemical, metallurgical, dimensional, physical, electrical, reliability testing or test validation

3.1.6
laboratory scope
quality record containing the following:
• specific tests, evaluations and calibrations that a laboratory is qualified to perform,
• list of the equipment which it uses to perform the above,
• list of methods and standards to which it performs the above
3.1.7
manufacturing
refers to the processes making or fabricating production materials, or production or service parts, or assemblies, or heat treating, painting, plating or other finishing services.

3.1.8
outsourcing
process of acquiring product from outside the organization

3.1.9
predictive maintenance
activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes to prevent disruption of production

3.1.10
premium freight
charges incurred additional to contracted delivery

3.1.11
remote location
location that supports sites and at which non production processes occur

3.1.12
site
location at which value added production processes occur
NOTE 1 Includes distributors of parts manufactured by other companies.
NOTE 2 Does not include suppliers of indirect materials, products.

3.1.13
special characteristics
product characteristics or manufacturing process parameters subject to variation which may affect safety or compliance with regulations, fit, function, performance or subsequent processing of product

Terms and definitions (3~3.1.2)

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3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
Supplier organization customer
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
Throughout the text of this International Standard, wherever the term «product» occurs, it can also mean “service”.

3.1 Terms and definitions for the automotive industry
For the purposes of this Technical Specification, the terms and definitions given in ISO 9000 : 2000 and the
following apply. However where there are terms for which the wording of the definition differs in ISO 9000: 2000, the definitions given in this Technical Specification apply.

3.1.1
continual improvement
optimization of characteristics and parameters of a product or process at a target value
NOTE Continual improvement is only applicable where conformance has been established.

3.1.2
control plan
documented descriptions of the systems for controlling parts and processes to provide control of all characteristics important for quality and engineering requirements

Normative reference (2)

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2 Normative reference
The following normative document contains provisions, which, through reference in this text, constitute provisions of this Technical Specification. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Technical Specification are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.

ISO 9000 :2000, Quality management systems Fundamentals and vocabulary.

Application (1.2)

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1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirements) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.
Permitted exclusions do not include manufacturing process design. For vehicles assembly plants, the authorized exclusions will be prescribed by IATF.

Scope,General (1,1.1)

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1 Scope

1.1 General
This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.

This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design/development, production and, when relevant, installation and servicing of automotive related products.
This Technical Specification is applicable to production and service part organization sites where customer specified products are manufactured.
Remote locations such as design centres, corporate headquarters and distribution centres as they support the site form part of the site audit, but cannot obtain stand alone certification to this Technical Specification.

This Technical Specification can also be applied throughout the automotive supply chain.

Goal of this Technical Specification(0.5)

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0.5 Goal of this Technical Specification
The goal of this Technical Specification is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.

This Technical Specification coupled with customer specific requirements that may apply defines the fundamental quality management system requirements for those subscribing to this document.

This Technical Specification is intended to avoid multiple certification audits and provide a common automotive approach to a quality management system.

Compatibility with other management systems(0.4)

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0.4 Compatibility with other management systems
This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community.
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management systems) in order to establish a quality management system that complies with the requirements of this International Standard.

Relationship with ISO 9004 (0.3)

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0.3 Relationship with ISO 9004
The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently.
Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.

NOTE The knowledge and use of the eight quality management principles referred to in the ISO 9000:2000 and ISO 9004:2000 can be demonstrated and cascaded through the organization by top management.

0.3.1 IATF Guidance to ISO/TS 16949 : 2002
"IATF Guidance to ISO/TS 16949 : 2002" contains recommended automotive industry practices, examples, illustrations and explanations that, if used may provide assistance in the application to conform to the requirements of this Technical Specification.

It is not intended for certification or for contractual purposes

Process approach (0.2)

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0.2 Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of
a) understanding and fulfilling requirements,
b) the need to consider processes in terms of added value,
c) obtaining results of process performance and effectiveness, and
d) continual improvement of processes based on objective measurement.

The model of a process based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
NOTE In addition, the methodology known as "Plan Do Check Act" (PDCA) can be applied to all processes. PDCA can be briefly described as follows.

Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies.

Do: implement the processes.

Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.

Act: take actions to continually improve process performance.

Requirements Introduction , General (1)

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0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements.
The quality management principles stated in ISO 9001 and ISO 9004 have been taken into consideration during the development of this International Standard.

ISO/TS16949 : 2002 Requirement English Version(8.5.3)

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8.5.3 Preventive action
The organisation shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
a) A documented procedure shall be established to define requirements for
b) determining potential non conformities and their causes,
c) evaluating the need for action to prevent occurrence of non conformities,
d) determining and implementing action needed,
e) records of results of action taken (see 4.2.4), and
f) reviewing preventive action taken.

ISO/TS16949 : 2002 Requirement English Version(8.5.2.1~8.5.2.4)

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8.5.2.1 Problem solving
The organization shall have a defined process for problem solving leading to root cause identification and elimination. If a customer prescribed problem solving format exists, the organization shall use the prescribed format.

8.5.2.2 Error proofing
The organisation shall use error proofing methods in their corrective action process.

8.5.2.3 Corrective action impact
The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity.

8.5.2.4 Rejected product test/analysis
The organization shall analyse parts rejected by the customer's manufacturing plants, engineering facilities and dealerships. The organization shall minimize the cycle time of this process. Records of these analyses shall be kept and made available upon request. The organization shall perform analysis and, initiate corrective action to prevent recurrence.
NOTE Cycle time related to rejected product analysis should be consistent with determination of root cause, corrective action and monitoring the effectiveness of implementation.

ISO/TS16949 : 2002 Requirement English Version(8.5.2)

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8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for

a) reviewing non conformities (including customer complaints),
b) determining the causes of non conformities ,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken (see 4.2.4), and
f) reviewing corrective action taken.

ISO/TS16949 : 2002 Requirement English Version(8.5,8.5.1~8.5.1.2)

2007-04-22T09:12:00.000-07:00

8.5 Improvement
8.5 1 Continual improvement
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

8.5.1.1 Continual improvement of the organization
The organization shall define a process for continual improvement (see annex B of ISO 9004 : 2000).

8.5.1.2 Manufacturing process improvement
Continual improvement shall focus upon control and reduction of variation in products characteristics and manufacturing process parameters.
NOTE 1 Controlled characteristics are documented in the control plan.
NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable or product characteristics are predictable and meet customer requirements.

ISO/TS16949 : 2002 Requirement English Version(8.4,8.4.1)

2007-04-22T09:10:00.000-07:00

8.4 Analysis of data
The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to

a) customer satisfaction (see 8.2.1),
b) conformance to product requirements (see 7.2.1),
c) characteristics and trends of processes and products including opportunities for preventive action, and
d) suppliers.

8.4.1 Analysis and use of data
Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following
- development of priorities for prompt solutions to customer related problems,
- determination of key customer related trends and correlation to support status review, decision making and longer term planning,
- an information system for the timely reporting of product information arising from usage. NOTE Data should be compared with those of competitors and/or appropriate benchmarks.

ISO/TS16949 : 2002 Requirement English Version(8.3.1~8.3.4)

2007-04-22T09:09:00.000-07:00

8.3.1 Control of nonconforming product Supplemental
Product with unidentified or suspect status shall be classified as nonconforming product (see 7.5.3).

8.3.2 Control of reworked product
instructions for rework, including re inspection requirements, shall be accessible to and utilized by the appropriate personnel.

8.3.3 Customer information
Customers shall be informed promptly in the event that nonconforming product has been shipped.

8.3.4 Customer waiver
The organization shall obtain customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved.
The organization shall maintain a record of the expiration date or quantity authorized. The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped on an authorization shall be properly identified on each shipping container.
This applies equally to purchased product. The organization shall agree with any requests from suppliers before submission to the customer.

ISO/TS16949 : 2002 Requirement English Version(8.3)

2007-04-22T09:08:00.000-07:00

8.3 Control of nonconforming product
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. The organization shall deal with nonconforming product by one or more of the following ways:

a) by taking action to eliminate the detected nonconformity;
b) by authorising its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application

Records of the nature of non conformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).
When nonconforming product is corrected it shall be subject to re verification to demonstrate conformity to the requirements.

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.

ISO/TS16949 : 2002 Requirement English Version(8.2.4~8.2.4.2)

2007-04-22T09:05:00.000-07:00

8.2.4 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1).

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the persons) authorizing release of product (see 4.2.4).

Product release and service delivery shall not proceed until all the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer.

NOTE When selecting product parameters to monitor compliance to specified internal and external requirements, the organization determine the types of product characteristics, leading to
- the types of measurement,
- suitable measurement means, and
- the capability and skills required.

8.2.4.1 Layout inspection and functional testing
A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for all products at sufficiently frequent intervals as specified in the control plan. Results shall be available for customer review.

NOTE Layout inspection is a complete measurement of all part dimensions shown on the design records.

8.2.4.2 Appearance items
For organizations manufacturing parts designated by the customer as "appearance items", the organization shall provide
appropriate resources including lighting for evaluation,
masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI) as appropriate,
maintenance and control of appearance masters and evaluation equipment, and
verification that personnel making appearance evaluations are qualified to do so.

ISO/TS16949 : 2002 Requirement English Version(8.2.3,8.2.3.1)

2007-04-22T09:04:00.000-07:00

8.2.3 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to
achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

8.2.3.1 Monitoring and measurement of manufacturing processes
The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria.
The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified
measurement techniques,
sampling plans,
acceptance criteria, and
reaction plans when acceptance criteria are not met.
Significant process events such as tool change, machine repair shall be noted on the control charts.
The organization shall initiate a reaction plan from the control plan for characteristics that are either unstable or non capable. These reaction plans shall include containment of product and 100% inspection as appropriate. A corrective action plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans shall be reviewed with and approved by the customer when so required.
The organization shall maintain records of effective dates of process changes.

ISO/TS16949 : 2002 Requirement English Version(8.2.2.1~8.2.2.5)

2007-04-22T09:02:00.000-07:00

8.2.2.1 Quality management system audit
The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.

8.2.2.2 Manufacturing process audit
The organization shall audit each manufacturing process to determine its effectiveness.

8.2.2.3 Product audit
The organization shall audit products at appropriate stages of production and delivery to verify conformance to all specified requirements, such as product dimensions, functionality, packaging, labelling, at a defined frequency.

8.2.2.4 Internal audit plans
Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan.
When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately increased.

NOTE Specific checklists should be used for each audit.

8.2.2.5 Internal auditor qualification
The organization shall have internal auditors who are qualified to audit the requirements of this Technical Specification( see 6.2.2.2).

ISO/TS16949 : 2002 Requirement English Version(8.2.2)

2007-04-22T09:01:00.000-07:00

8.2.2 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.

An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected non conformities and their causes. Follow up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).

NOTE See ISO 10011 1, ISO 10011 2 and ISO 10011 3 for guidance.

ISO/TS16949 : 2002 Requirement English Version(8.2,8.2.1)

2007-04-22T08:59:00.000-07:00

8.2 Monitoring and measurement

8.2.1 Customer satisfaction
As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

NOTE Consideration should be given to both internal and external customers.
8.2.1.1 Customer satisfaction Supplemental
Customer satisfaction with the organization shall be monitored through continual evaluation of performance of the realization processes. Performance indicators shall be based on objective data and include, but not be limited to:
- delivered part quality performance,
- customer disruptions including field returns,
- delivery schedule performance (including incidents of premium freight),
- customer notifications related to quality or delivery issues.

The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process.

ISO/TS16949 : 2002 Requirement English Version(8,8.1)

2007-04-22T08:57:00.000-07:00

8 Measurement, analysis and improvement

8.1 General
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
a) to demonstrate conformity of the product
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.

This shall include determination of applicable methods, including statistical techniques, and the extent of their use.

8.1.1 Identification of statistical tools
Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan.

8.1.2 Knowledge of basic statistical concepts
Basic statistical concepts, such as variation, control (stability), process capability and over adjustment shall be understood and utilized throughout the organization

ISO/TS16949 : 2002 Requirement English Version(7.6.3.2)

2007-04-22T08:55:00.000-07:00

7.6.3.2 External laboratory
External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent, or
- there shall be evidence that the external laboratory is acceptable to the customer.

NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer approved second party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent.

NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 7.6.3.1 have been met.

ISO/TS16949 : 2002 Requirement English Version(7.6.3,7.6.3.1)

2007-04-21T23:37:00.000-07:00

7.6.3 Laboratory requirements

7.6.3.1 Internal laboratory
An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall comply with technical requirements including

- adequacy of the laboratory procedures,
- qualifications of the laboratory personnel conducting tests,
- testing of the commodity (ies),
- capability to perform these tests correctly, traceable to the relevant process standard (e.g. ASTM), and,
- review of the related quality records.

NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in house laboratory conformity to this requirement but is not mandatory.

ISO/TS16949 : 2002 Requirement English Version(7.6.1,7.6.2)

2007-04-21T23:36:00.001-07:00

7.6.1 Measurement system analysis
Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis.

NOTE When there are no customer requirements, refer to ISO 10012 1 and ISO 10012 2.

7.6.2 Calibration records
Records of the calibration activity for all gauges, measuring and test equipment, including employee and customer owned gauges, shall include

- equipment identification, including the measurement standard against which the equipment is calibrated,
- revisions following engineering changes,
- any out of specification readings as received for calibration/verification,
- an assessment of the impact of out of specification condition,
- statements of conformance to specification after calibration/verification, and
- notification to the customer if suspect product or material has been shipped.

ISO/TS16949 : 2002 Requirement English Version(7.6)

2007-04-21T23:34:00.000-07:00

7.6 Control of monitoring and measuring devices
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment shall

a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
b) be adjusted or re adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment
and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. NOTE See ISO 10012 1 and ISO 10012 2 for guidance.

NOTE A number or other identifier traceable to the device calibration record meets the intent of requirement c) above.

ISO/TS16949 : 2002 Requirement English Version(7.5.5)

2007-04-21T23:31:00.000-07:00

7.5.5 Preservation of product
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

7.5.5.1 Storage and inventory
In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals.

The organization shall use an inventory management system to optimize inventory turns over time and assure stock rotation, such as "first in first out" (FIFO). Obsolete product shall be controlled in a similar manner to nonconforming product.

ISO/TS16949 : 2002 Requirement English Version(7.5.4)

2007-04-21T23:30:00.000-07:00

7.5.4 Customer property

The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).

NOTE Customer property can include intellectual property.

NOTE Customer owned returnable packaging is included in this element.

7.5.4.1 Customer owned production tooling
Customer owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that the ownership of each item is visible, and can be determined.

ISO/TS16949 : 2002 Requirement English Version(7.5.3)

2007-04-21T23:28:00.001-07:00

7.5.3 Identification and traceability
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
The organization shall identify the product status with respect to monitoring and measurement requirements.

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.
NOTE Inspection and test status is not indicated by the location of product in the production flow unless inherently obvious such as material in an automated production transfer process. Alternatives are permitted, if the status is clearly identified, documented, and achieves the designated purpose.

7.5.3.1 Identification and traceability Supplemental
The words "Where appropriate" in 7.5.3 above, shall not apply.

ISO/TS16949 : 2002 Requirement English Version(7.5.2)

2007-04-21T23:27:00.000-07:00

7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable

a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.

7.5.2.1 Validation of processes for production and service provision – Supplemental
The requirements of 7.5.2 shall apply to all processes for production and service provision.

ISO/TS16949 : 2002 Requirement English Version(7.5.1.6,7.5.1.7,7.5.1.8)

2007-04-21T23:26:00.000-07:00

7.5.1.6 Production scheduling
Production shall be scheduled in order to meet customer requirements, such as just in time supported by an information system that permits access to production information at key stages of the process and is order driven.

7.5.1.7 Feedback of information from service
A process for communication of information on service concerns to manufacturing, engineering and design activities shall be established and maintained.
NOTE The intent of the addition of "service concerns" to this element is to ensure that the organization is aware of non conformities that occur external to its organization.

7.5.1.8 Servicing agreement with customer
When there is a servicing agreement with the customer, the organization shall verify the effectiveness of
- any organization service centres,
- any special purpose tools or measurement equipment, and
- the training of servicing personnel.

ISO/TS16949 : 2002 Requirement English Version(7.5.1.5)

2007-04-21T23:24:00.000-07:00

7.5.1.5 Management of production tooling
The organization shall provide resources for tool and gauge design, fabrication and verification activities.
The organization shall establish and implement a system for production tooling management including
- maintenance and repair facilities and personnel,
- storage and recovery,
- set up,
- tool change programmes for perishable tools,
- tool design modification documentation, including engineering change level,
- tool modification and revision to documentation,
- tool identification, defining the status, such as production, repair or disposal.
The organization shall implement a system to monitor these activities if any work is outsourced.

NOTE This requirement also applies to the availability of tools for vehicle service parts.

ISO/TS16949 : 2002 Requirement English Version(7.5,7.5.1,7.5.1.1)

2007-04-21T23:20:00.000-07:00

7.5 Production and service provision

7.5.1 Control of production and service provision
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, as necessary, c) the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and post delivery activities.

7.5.1.1 Control plan
The organization shall
- develop control plans at the system, subsystem, component and/or material level, for the product supplied, including those for processes producing bulk materials as well as parts, and
- have a control plan for pre launch and production that take into account the design FMEA and
- manufacturing process FMEA outputs,

The control plan shall
- list the controls used for the manufacturing process control ,
- include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both the customer and the organization,
- include the customer required information, if any, and
- initiate the specified reaction plan (see 8.2.3.1) when the process becomes unstable or not statistically capable.

Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources or FMEA (see 7.1.4).
NOTE Customer approval may be required after review or update of the control plan.

ISO/TS16949 : 2002 Requirement English Version(7.4.3)

2007-04-21T23:18:00.000-07:00

7.4.3 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

7.4.3.1 Incoming product quality
The organization shall have a process to assure the quality of purchased product (see 7.4.3) utilizing one or more of the following methods:
- receipt of, and evaluation of, statistical data by the organization;
- receiving inspection and/or testing such as sampling based on performance;
- second or third party assessments or audits of supplier sites, when coupled with records of acceptable quality performance;
- part evaluation by a designated laboratory;
- another method agreed with the customer.

7.4.3.2 Supplier monitoring
Supplier performance shall be monitored through the following indicators
- delivered part quality performance,
- customer disruptions including field returns,
- delivery schedule performance (including incidents of premium freight),
- special status customer notifications related to quality or delivery issues.
The organization shall promote supplier monitoring of the performance of their manufacturing processes.

ISO/TS16949 : 2002 Requirement English Version(7.4.2)

2007-04-21T23:16:00.000-07:00

7.4.2 Purchasing information
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.

The organisation shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

ISO/TS16949 : 2002 Requirement English Version(7.4,7.4.1)

2007-04-21T23:14:00.000-07:00

7.4 Purchasing

7.4.1 Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization shall evaluate and select suppliers based on their ability to supply products in accordance with the organization's requirements. Criteria for selection, evaluation, and re evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4)
NOTE 1 Purchased products above includes all products and services that affect customer requirements such as sub assembly, sequencing, sorting, rework and calibration services.
NOTE 2 When there are mergers, acquisitions or affiliations associated with suppliers, the organization should verify the continuity of the supplier's quality system and its effectiveness.

7.4.1.1 Regulatory compliance
All purchased products or materials used in product shall satisfy applicable regulatory requirements.

7.4.1.2 Supplier quality management system development
As a first step, suppliers to the organization shall be third party registered to ISO 9001 : 2000 by an accredited third party certification body.
The organization shall perform supplier quality management system development with the goal of supplier compliance to this Technical Specification.
NOTE 1 Compliance to ISO 9001 : 2000 is required by 15 December 2003.
NOTE 2 The customer may mandate alternative requirements.
NOTE 3 The prioritisation of suppliers for development depends upon, for example, the supplier's quality performance and the importance of the product, material or service supplied.

7.4.1.3 Customer approved sources
Where specified by the contract (e.g. customer engineering drawing, specification), the organization shall purchase products, materials or services from approved sources.
The use of customer designated sources, including tool/gauge suppliers, does not relieve the organization of the responsibility for ensuring the quality of purchased products.

ISO/TS16949 : 2002 Requirement English Version(7.3.7)

2007-04-21T23:13:00.000-07:00

7.3.7 Control of design and development changes
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and already delivered product.
Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
NOTE 1 Design and development changes include all changes during the product programme life (see 7.1.4).

ISO/TS16949 : 2002 Requirement English Version(7.3.5,7.3.6)

2007-04-21T23:11:00.000-07:00

7.3.5 Design and development verification
Verification shall be performed in accordance with planned arrangements (see 7.3.1 ) to ensure that the design and development outputs have satisfied the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).

7.3.6 Design and development validation
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).
NOTE 1 The validation process should include an analysis of field reports.
NOTE 2 The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing processes.

7.3.6.1 Design and development validation Supplemental

Design and development validation shall be performed in accordance with customer requirements including programme timing.

7.3.6.2 Prototype programme
When required by the customer, the organization shall have a prototype programme and control plan. The organization shall use, wherever possible, the same suppliers, tooling and manufacturing processes as will be used in production.
All performance testing activities shall be monitored for timely completion and conformance to requirements.
While services may be outsourced, the organization shall be responsible for the subcontracted services, including technical leadership.

7.3.6.3 Product approval process
The organization shall conform to a product and process approval procedure recognized by the customer.
NOTE Product approval should be subsequent to the verification of the manufacturing process.

This product and manufacturing process approval procedure shall also be applied to suppliers.

ISO/TS16949 : 2002 Requirement English Version(7.3.4)

2007-04-21T23:10:00.000-07:00

7.3.4 Design and development review
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1 )

a) to evaluate the ability of the results of design and development to fulfil requirements, and
b) to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the design and development stages) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

NOTE These reviews are normally coordinated with the design phases and should include manufacturing process design and development.

7.3.4.1 Monitoring
Measurements at specified stages of design and development shall be defined, analysed and reported with summary results as an input to management review.
NOTE These measurements include quality risks, costs, lead times, critical paths and others, as appropriate.

ISO/TS16949 : 2002 Requirement English Version(7.3.3)

2007-04-21T23:09:00.000-07:00

7.3.3 Design and development outputs
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
Design and development outputs shall

a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use.

7.3.3.1 Product design outputs Supplemental
The product design output shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include
- design FMEA, reliability results,
- product special characteristics, specifications,
- product error proofing, as appropriate,
- product definition including drawings or mathematically based data,
- product design reviews results, and
- diagnostic guidelines where applicable.

7.3.3.2 Manufacturing process design output
The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design output shall include
- specifications and drawings,
- manufacturing process flow chart / layout,
- manufacturing process FMEAs,
- control plan ( see 7.5.1.2.),
- work instructions,
- process approval acceptance criteria,
- data for quality, reliability, maintainability and measurability,
- results of error proofing activities, as appropriate, and
- methods of rapid detection and feedback of product/manufacturing process nonconformities.

ISO/TS16949 : 2002 Requirement English Version(7.3.2)

2007-04-21T23:06:00.000-07:00

7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include

a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
NOTE Special characteristics (see 7.2.1.1) are included in this requirement.

7.3.2.1 Product design input
The organization shall identify, document and review the product design inputs requirements including
 customer requirements (contract review) such as special characteristics (see 7.3.2.3), identification, traceability and packaging;
 use of information; the organization shall have a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature;
 targets for product quality, life, reliability, durability, maintainability, timing and cost.

7.3.2.2 Manufacturing process design input
The organization shall identify, document and review the manufacturing process design input requirements, including
 product design output data,
 targets for productivity, process capability and cost,
 customers requirements, if any, and
 experience from previous developments.

NOTE The manufacturing process design includes the use error proofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered.

7.3.2.3 Special characteristics
The organization shall identify special characteristics (see 7.3.3 d) and

include all special characteristics in the control plan,
comply with customer specified definitions and symbols, and
identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer's special characteristic symbol or the organization's equivalent symbol or notation to include those process steps that affect special characteristics.

NOTE Special characteristics can include product characteristics and process parameters.

ISO/TS16949 : 2002 Requirement English Version(7.3,7.3.1)

2007-04-21T23:04:00.000-07:00

7.3 Design and development
NOTE The requirements of element 7.3 include product and manufacturing process design and development, and focus on error prevention rather than detection.
7.3.1 Design and development planning
The organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine

a) the design and development stages,
b) the review, verification and validation that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.

The organisation shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Planning output shall be updated, as appropriate, as the design and development progresses.

7.3.1.1 Multidisciplinary approach
The organization shall use a multidisciplinary approach to prepare for product realization, including
- development/ finalization and monitoring of special characteristics,
- development and review of FMEAs including actions to reduce potential risks, and
- development and review of control plans. NOTE A multidisciplinary approach typically includes the organization's design, manufacturing, engineering, quality, production and other appropriate personnel.

ISO/TS16949 : 2002 Requirement English Version(7.2.3)

2007-04-21T23:02:00.000-07:00

7.2.3 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to
a) product information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.

7.2.3.1 Customer communication Supplemental
The organization shall have the ability to communicate necessary information, including data, in a customer-specified language and format (e.g. computer aided design data, electronic data exchange).

ISO/TS16949 : 2002 Requirement English Version(7.2.2)

2007-04-21T23:00:00.000-07:00

7.2.2 Review of requirements related to the product
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

NOTE Waiving the requirement of the formal review in the above note requires customer authorization.

7.2.2.1 Organization manufacturing feasibility
The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis.

ISO/TS16949 : 2002 Requirement English Version(7.2,7.2.1)

2007-04-21T22:59:00.000-07:00

7.2 Customer related processes

7.2.1 Determination of requirements related to the product
The organization shall determine

a) requirements specified by the customer, including the requirements for delivery and post delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organization.

NOTE 1 Post delivery activities include any after sales product servicing provided as part of the customer contract or purchase order.
NOTE 2 This requirement includes recycling, environmental impact and characteristics identified as a result of the organization's knowledge of the product and manufacturing processes ( see 7.3.2.3).
NOTE 3 Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.

7.2.1.1 Customer designated special characteristics
The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.

ISO/TS16949 : 2002 Requirement English Version(7,7.1)

2007-04-21T22:57:00.000-07:00

7 Product realization

7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) he need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

The output of this planning shall be in a form suitable for the organization's method of operations.

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product realization. Advanced product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection and is based on a multidisciplinary approach.

7.1.1 Planning of product realization Supplemental
Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan.

7.1.2 Acceptance criteria
Acceptance criteria shall be defined by the organization and, where required, approved by the customer. For attribute data sampling, acceptance criteria shall be zero defects.

7.1.3 Confidentiality
The organization shall ensure the confidentiality of customer contracted products and projects under development, and related product information.

7.1.4 Change control
The organization shall have a process to control and react to changes that impact product realization including those initiated by the supplier. The effects of any change shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation.
For proprietary designs, impact on form, fit and function (including performance, and/or durability) shall be reviewed with the customer so that all effects can be properly evaluated.
When required by the customer, additional verification/identification requirements, such as those required for new product introduction, shall be met.

NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer.
NOTE 2 This applies to product and manufacturing process changes.

ISO/TS16949 : 2002 Requirement English Version(6.4)

2007-04-21T22:56:00.000-07:00

6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

6.4.1 Personnel safety
Product safety and means to minimize potential risks to employees shall be addressed in the organization's quality policy and practices, especially in the design and development process and in manufacturing process activities.

6.4.2 Cleanliness of premises
The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product

ISO/TS16949 : 2002 Requirement English Version(6.3)

2007-04-21T22:54:00.000-07:00

6.3 infrastructure

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable

a) buildings, workspace and associated utilities,
b) process equipment,( both hardware and software ), and
c) supporting services ( such as transport or communication ).

6.3.1 Plant, facility and equipment planning
The organization shall use a multidisciplinary approach for developing plant, facility and equipment plans. Plant layouts shall optimise material travel, handling and value added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.
NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.

6.3.2 Contingency plans
The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns .

ISO/TS16949 : 2002 Requirement English Version(6.2.2)

2007-04-21T22:53:00.000-07:00

6.2.2 Competence, awareness and training
The organization shall

a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience.

6.2.2.1 Product design skills
The organization shall ensure that personnel with product design responsibility are qualified to achieve design requirements and are skilled in applicable tools and techniques.
Applicable tools and techniques shall be identified by the organization.

6.2.2.2 Training
The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified on the basis of education, training, skills and/or experience, as required. Attention shall be given to satisfy customer specific requirements.
NOTE 1 This applies to all employees affecting quality at all levels of the organization.
NOTE 2 An example of the customer specific requirements is the application of digitised mathematically based data.

6.2.2.3 Training on the job
The organization shall provide on the job training for personnel in any new or modified job affecting product quality including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements.

6.2.2.4 Employee motivation and empowerment
The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.

The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (see 6.2.2 d).

ISO/TS16949 : 2002 Requirement English Version(6,6.1,6.2,6.2.1)

2007-04-21T22:46:00.000-07:00

6 Resource management

6.1 Provision of resources
The organization shall determine and provide the resources needed

a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.

6.2 Human resources

6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

ISO/TS16949 : 2002 Requirement English Version(5.6.2,5.6.3)

2007-04-21T22:42:00.000-07:00

5.6.2 Review input
The input to management review shall include information on
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow up actions from previous management reviews,
f) planned changes that could affect the quality management system, and
g) recommendations for improvement.

5.6.2.1 Review input Supplemental
Input to management review shall include an analysis of actual and potential field failures and their impact on quality, safety, or the environment.

5.6.3 Review output
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.

ISO/TS16949 : 2002 Requirement English Version(5.6,5.6.1)

2007-04-21T22:41:00.000-07:00

5.6 Management review

5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management reviews shall be maintained (see 4.2.4).

5.6.1.1 Quality management system performance
These reviews shall include all elements of the quality management system and its performance trends as an essential part of the continual improvement process.

Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1).
These results shall be recorded to provide, as a minimum, evidence of the achievement of
the objectives specified in the quality policy,
the objectives specified in the business plan, and
customer satisfaction with product supplied.

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7.3.4 Design and development review

7.3.3.2 Manufacturing process design output

7.3.3.1 Product design outputs — Supplemental

7.3.3 Design and development outputs

7.3.2 Design and development inputs

7.3 Design and development

7.2.3 Customer communication

7.2.2 Review of requirements related to the product

7.2 Customer-related processes

7 Product realization

6.4 Work environment

6.3 Infrastructure

6.2.2 Competence, training and awareness

6.2 Human resources

6 Resource management

5.6.3 Review output

5.6.2 Review input

5.6 Management review

5.5.3 Internal communication

5.5.2 Management representative

5.5 Responsibility, authority and communication

5.4.2 Quality management system planning

5.4 Planning

5.3 Quality policy

5.2 Customer focus

5 Management responsibility

4.2.4 Control of records

4.2.3 Control of documents

4.2.2 Quality manual

4.2 Documentation requirements

4 Quality management system

2 Normative references - 3.1.12

1.2 Application

Quality management systems

0.5 Goal of this Technical Specification

0.4 Compatibility with other management systems

0.3 Relationship with ISO 9004

0.2 Process approach

Introduction ISO/TS16949:2009

What is ISO50001

Good manufacturing practice

What is New in ISO/TS16949:2009

A.2 Elements of the control plan

Annex A (normative) Control plan (A.1)

Design responsible organization (3.1.3~3.1.13)

Terms and definitions (3~3.1.2)

Normative reference (2)

Application (1.2)

Scope,General (1,1.1)

Goal of this Technical Specification(0.5)

Compatibility with other management systems(0.4)

Relationship with ISO 9004 (0.3)

Process approach (0.2)

Requirements Introduction , General (1)

ISO/TS16949 : 2002 Requirement English Version(8.5.3)

ISO/TS16949 : 2002 Requirement English Version(8.5.2.1~8.5.2.4)

ISO/TS16949 : 2002 Requirement English Version(8.5.2)

ISO/TS16949 : 2002 Requirement English Version(8.5,8.5.1~8.5.1.2)

ISO/TS16949 : 2002 Requirement English Version(8.4,8.4.1)

ISO/TS16949 : 2002 Requirement English Version(8.3.1~8.3.4)

ISO/TS16949 : 2002 Requirement English Version(8.3)

ISO/TS16949 : 2002 Requirement English Version(8.2.4~8.2.4.2)

ISO/TS16949 : 2002 Requirement English Version(8.2.3,8.2.3.1)

ISO/TS16949 : 2002 Requirement English Version(8.2.2.1~8.2.2.5)

ISO/TS16949 : 2002 Requirement English Version(8.2.2)

ISO/TS16949 : 2002 Requirement English Version(8.2,8.2.1)

ISO/TS16949 : 2002 Requirement English Version(8,8.1)

ISO/TS16949 : 2002 Requirement English Version(7.6.3.2)

ISO/TS16949 : 2002 Requirement English Version(7.6.3,7.6.3.1)

ISO/TS16949 : 2002 Requirement English Version(7.6.1,7.6.2)

ISO/TS16949 : 2002 Requirement English Version(7.6)

Supply Chain Management: A Logistics Perspective (with Student CD-ROM)
By John J. Coyle, C. John Langley, Brian Gibson, Robert A. Novack, Edward J. Bardi