Design and development
The ISO Navigator™ database hyperlinks the ISO 9000 principles and the ISO 9001 requirements; and explains them in plain English with practical guidance.
ISO 9001: Design and development review 7.3.4
Design review is a periodic and planned activity undertaken during the design process that helps ensure you are on the right track.
The objective of the design review is to identify and remove barriers to a successful design. Undertake systematic reviews of the design and development planning process by determining:
- Whether the results conform to the specified requirements
- Gaps in the design
- The types of records that are required
At key stages of the design relevant people should review the design to ensure that the inputs are met and to identify and resolve any technical problems. Records, e.g. review meeting minutes, etc. should show who attended, that all concerned parties were present and that all actions were satisfied before proceeding forward with the design process.
The intent of design reviews with 'representatives of functions concerned' is that other parties in the organization 'interact' with the design function i.e. purchasing, quality, manufacturing (design hand off), etc.