7 Product realization

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.