I hate to assume but the new 1.2 clause only pertains to clause 7.0 design issues? The company Im writing for does not do design, so I would assume this to be true. Anyhelp would be appreciated.

I think clause 1.2 is pretty straight forward.

Clause 7 contains a lot more than design control stuff. In fact it contains components from twelve of the previous 20 elements of ISO 9001:1994.

If you don't do design, you don't do design. Say this in your documented system. Explain it to the auditors when they ask you about it. No problems, provided you're not trying to pull the wool over the auditors eyes.

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Appreciate the help!!! Originally posted by David Mullins:
I think clause 1.2 is pretty straight forward.

Clause 7 contains a lot more than design control stuff. In fact it contains components from twelve of the previous 20 elements of ISO 9001:1994.

If you don't do design, you don't do design. Say this in your documented system. Explain it to the auditors when they ask you about it. No problems, provided you're not trying to pull the wool over the auditors eyes.

Careful, careful boys and girls!

I recently attended a seminar on ISO 9K:2K and we discussed this very topic. There were service based companies in the group.

I don't think design necessarily applies to 'designing a wheel'. I think if your service is marketing, it would apply to how you 'design' your campaign.

The other thing is that if you contract out your design work, you still have to include design in your procedures. You have to show that you have control over this process, even though you aren't carrying it out yourself. If you leave design out, you must exclude any product/service, that is affected by the design process, out of your scope.

I'm not sure what your company does, so it is difficult to comment.

Hope this is a little insightful.

Fire Girl
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I posted a response to this (too long to retype) under topic: 7.5.1 and 7.5.2??

I appreciated the help in the forum...
The business I am in is strictly consulting service...which helps companies get HAACP certified the two things that we provide is technical expertise (product also considered service) and we also sell chemicals through the company to the customers...we get certs of analysis that qualifies the prodcut (chemical)...
So I think Im in the clear on the design issue...but Im having a tough time (as I did 4.9 "special processes" rectification) in 7.5.1 and 7.5.2 about the monitoring and measuring devices..we don't use any monitoring or measuring devices sans customer satisfaction and complaints as a gauge.....
Curious what you think...can I exclude some parts of the 7.5.1 and 7.5.2 and just note them as justified in the exclusion table in section 1.0/1.2....

Appreciate any help...hope Im not taking any of you time up too much..

Thanks
Chris

Dawn,

Service industries are not mystical. Every thought we have is not instantly design because we're in a service area.

If someone outsouces their design activities, this is covered under Purchasing.

Personally I think your auditors would be a little sensitive about handing out registrations that preclude products involving design with out a very good reason. Otherwise you'd avoid design control, but give the outward appearance that you're ISO 9001 registered for your whole business. I believe there must still be some ethics left in Registrars and Quality Managers (I won't mention consultants today).

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