Activities Outside of an ISO 9001 QMS Scope

[John Mann]

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?

 

[Phil Fields]

Re: Activities outside scope of QMS

Why would you not want to include it in your scope?
How is Quality managed within the mechanical sysrem?

Phil

 

[John Mann]

Re: Activities outside scope of QMS

Why would you not want to include it in your scope?
How is Quality managed within the mechanical sysrem?

Phil

I do want to include it in the scope, however as things stand the process (not designed by me) is not compliant.

 

[AndyN]

Re: Activities outside scope of QMS

Hello John:

Is the mechaincal product manufactured by your defined QMS. If it is, the mechanical design process would have to be included (see the appplication notes in the front of the standard - can't remember which section, 1,0 maybe). If you don't manufacture it, then there's not much you can do, or maybe there is.........

This attitude of management is strange, isn't it? They do things to get registered, then 'select' things for inclusion, when the systems in place.

One relief will be from biding your time. Not following a review process etc. will result in many problems - trust me on this, I was in Design Quality! The key to this relief is you getting cost numbers on the design changes made, when they were't required by Marketing/the customer.

That normally makes them take notice......plus the manufacturing folks will be annoyed over delays, false starts and inventory problems too. You could just put a number to those from current experience and project it, but there's no pain in that, normally.

 

[Matt M - 2009]

Re: Activities outside scope of QMS

Hi John,
Though the design is outside your current scope, I cannot see an outside auditor sitting still on it. I would imagine they would at least make an observation that management should consider expanding your scope to include it.