7.3 Design and development

7.3  Design and development

NOTE   The requirements of 7.3 include product and manufacturing process design and development, and focus on error prevention rather than detection.

ISO 9001:2008, Quality management systems — Requirements

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 organization 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.

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

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