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  ISO 9001/4:2000
  Regulatory and Legal Requirements

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Author Topic:   Regulatory and Legal Requirements
energy
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Posts: 228
From:New Britain, CT
Registered: Nov 2000

posted 21 November 2000 12:48 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
I understand regulatory requirements. Can any one give an example of Legal requirements as it applies to ISO 9000:2000. I'm sure it's simple, but, so am I. Thanx

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Marc Smith
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From:West Chester, OH, USA
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posted 21 November 2000 01:57 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
The way to think of this is to ask your self what legal requirements are applicable to your business / product. All ISO says is that you have to comply with applicable laws.

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David Mullins
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Posts: 248
From:Adelaide, South Australia, Australia
Registered: Nov 1999

posted 21 November 2000 05:47 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
Firstly I'd suggest you should thically be complying with legal requirements associated with the "products" of the company.

Secondly I'd recommend we wait and see what is in the actual 9001:2000 standard.

As an aside, I asked the Australian Quality Council (who administer the Australian Business Excellence Awards - similar to Baldrige) about them providing consultancy work and advice in areas of business improvement, and determining whether to improve things or not. I asked what would happen if they consulted with two ISO 9001:2000 registered/certified companies who were subsequently sued in relation to inactivity of correcting problems upon the advice of the consultant, and used this in mitigation to deminish their compensation liability.

Then the two companies used their registration/certification to attempt to further mitigate their position, based on their Registrar having conducted a surveillance audit of the premises only several days prior to the event. The two companies claimed they believed their legal position in relation to the risks associated with their "product" was sound, given that their external auditor had given them a clean bill of health.

Does the inclusion of legal requirements in 9001:2000 open a can of worms in terms of liability, litigation and mitigation, not just for the immediate company, but for external agencies?

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Alf Gulford
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Posts: 60
From:Portland, OR
Registered: Aug 2000

posted 21 November 2000 05:54 PM     Click Here to See the Profile for Alf Gulford   Click Here to Email Alf Gulford     Edit/Delete Message   Reply w/Quote
Marc-
Can you tell me where to find that reference? It's probably right in front of me but I once had an auditor from a ISO registrar pull that on me as he launched off into an FDA style investigation (this was his background and his comfort zone). I should heve called him on it but didn't, and never could find the reference.

Thanks.

Alf

[This message has been edited by Alf Gulford (edited 21 November 2000).]

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