7.3.2 Design and development inputs

ISO 9001:2008, Quality management systems — Requirements

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.

The 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 the following:

-   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 of 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