Guidance

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 changes 7.3.7

It is as important to control design changes throughout the design and development process and it should be clear how these changes are handled and what effects they have on the product. Ensure control over design and development changes, design changes must be:

  1. Identified
  2. Recorded
  3. Reviewed
  4. Verified
  5. Validated
  6. Approved

Design and development changes (after the original verification and validation) have to be verified and validated as appropriate (as well as reviewed) and to 'include evaluation of the effect of changes on constituent parts and products already delivered'.

If the organization chooses not to perform re-verification and re-validation on every design change, then the auditor should expect to see some very well defined criteria as to when the activity needs to occur.