7.3.4 Design and development review

ISO 9001:2008, Quality management systems — Requirements

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 meet 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 stage(s) 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 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.