Statutory & Regulatory Requirements - Comply with applicable laws - 7.2.1 (c)

Marc

Fully vaccinated are you?
Staff member
Admin
#1
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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D

David Mullins

#2
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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A

Alf Gulford

#3
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).]
 
E

energy

#4
Regulatory and Legal Requirements

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
 
R

romelnar

#5
Statutory vs. Regulatory Requirements: What's the difference?

i'm a bit confused as to what is a statutory requirement? a regulatory requirement? can anybody help me on these?

thanks.
 
J

Jon Shaver

#6
Statute = a law
Regulation = control of practices (to stay within a law)

Let's say the law says you can't kill your employees (seems reasonable). The regulation may require you to tell employees about hazards they may face.
 
R
#8
7.2.1 (c) Statutory & Regulatory Requirements

This clause used to be in design and is really part of that. Since we don't do any design, does anyone think I could exclude our company from this clause?
 

SteelMaiden

Super Moderator
Super Moderator
#9
Russ,

Depending upon your business, there are always some sort of regulatory and statutory requirements.

OSHA, EPA, your state laws ....the list goes on. A good source for state and local info would be your CFO.

Hope this helps you
 
E

energy

#10
Russ,
The guide lines say the "processes" as a result of legal or regulatory requirements. If you paint, there are air emissions and paint waste disposal standards. If you have machining centers, waste lubricant disposal. I don't quite understand how to address these issues, yet. We have State approved permits for waste water discharges and I haven't figured out how to tie them into an ISO document. OSHA, EPA, DEP regulations are separate nightmares, usually handled by a trained individual with expertise in those fields. I'm not doing anything about that clause until we can make sure that we aren't indulging in overkill. One example comes to mind, regarding the clause, where it is easy to see the application. If a company makes machinery or a product that is inherently dangerous, it is bound by law (OSHA)to incorporate mandatory safeguards to protect operators. Other than that, I'm lost. You may have to list what programs you have, person responsible and where the documents are stored. Like Steelmaiden says, everybody has them. I wouldn't advise to take exception. Auditors will be ready for that one, and they have enough ammunition as it is.

energy
 
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