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I am quality manager for a small company. We have held ISO9001 accreditation for 3 years. We design and build electronic equipment and write software. Our defined scope refers specifically to these activities.
A year ago it was decided the company would move into the field of mechanical design. I felt we could incorporate this (with slight modifications) into our existing design procedures, but it was decided to keep the process entirely separate. We’ve now come to the point where the mechanical design process is becoming active and my current estimation is that it is not ISO9001 compliant due to lack of documented design requirements and reviews.
However, despite this can we just say “Hey, it doesn’t matter if it’s compliant or not, since it’s not covered by our scope”, or must we extend our scope to cover this new area of activity?
A year ago it was decided the company would move into the field of mechanical design. I felt we could incorporate this (with slight modifications) into our existing design procedures, but it was decided to keep the process entirely separate. We’ve now come to the point where the mechanical design process is becoming active and my current estimation is that it is not ISO9001 compliant due to lack of documented design requirements and reviews.
However, despite this can we just say “Hey, it doesn’t matter if it’s compliant or not, since it’s not covered by our scope”, or must we extend our scope to cover this new area of activity?