ISO 9001 Implementation Guide

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7.3.7 Control of Design and development changes

Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.

Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).

(from BS EN ISO 9001:2000)

This clause requires all changes during the development stage to be identified and documented, then approved by someone with the proper authorization. It is also a clause that requires holistic thinking of the entire process (i.e., the importance of the system as a whole and the interdependence of its parts and/or processes).

Maintaining good records regarding this clause is an important part of the process in terms of the product’s development history and future. Using the car as an example again, if you’re designing the alternator and discover during its development that it needs to be interchangeable with an old one, that change should be documented immediately. That way, if you ever need to go back and find out why the design was changed, you have a record that points you in the right direction.

This clause also requires that an organization evaluate the effect of any design change on constituent parts and product already delivered. For example, if you change the size of the alternator and it now bumps against the oil pan and the fan belt, a chain reaction of design problems could occur without considering the design changes and their effects.

It’s important to have control over this process, because you don’t want just anyone changing your design—that can become costly or even a liability. Proper communication of all changes to relevant parties involved in design is strongly encouraged and should be considered necessary preventive action. Having a procedure to manage this action is definitely a good idea.

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