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  ISO 9001/4:2000
  7.2.1 (c) Statutory & Regulatory Requirements

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Author Topic:   7.2.1 (c) Statutory & Regulatory Requirements
Russ
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Posts: 31
From:Tipton, IN
Registered: Apr 2001

posted 11 July 2001 08:43 AM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
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?

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SteelMaiden
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Posts: 35
From:NC, USA
Registered: Jan 2001

posted 11 July 2001 08:59 AM     Click Here to See the Profile for SteelMaiden     Edit/Delete Message   Reply w/Quote
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

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energy
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Posts: 308
From:New Britain, CT
Registered: Nov 2000

posted 11 July 2001 01:26 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
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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James Gutherson
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Posts: 43
From:Sydney, NSW, Australia
Registered:

posted 11 July 2001 08:26 PM     Click Here to See the Profile for James Gutherson   Click Here to Email James Gutherson     Edit/Delete Message   Reply w/Quote
Just quickly,

What about your products, have you ensured that they have been designed and built and possibly tested to any legally required standards. In my previous life, Commercial Vessel Survey, new vessels that wish to operate commercially need to be designed and built and inspected according to universally accepted rules and this would be a regulatory requirement that needs to be addressed by any ship building organisation that is seeking ISO accreditation.

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ikar
unregistered
posted 12 July 2001 04:57 AM           Edit/Delete Message   Reply w/Quote
"7.2.1 The organization shall DETERMINE ...
c) statutory and regulatory requirements related to the product"

You see they say about only determination and not a fullfilment of reqs. I suppose that it is very similar with ISO 14001.
Don't worry.

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awk
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Posts: 21
From:Ontario, Canada
Registered: Sep 2000

posted 12 July 2001 08:27 AM     Click Here to See the Profile for awk   Click Here to Email awk     Edit/Delete Message   Reply w/Quote
A simple solution, if you have an overall process map showing their sequence and interactions, determine from this the regulatory & statutory requirements for the various areas. From this I advise clients to determine safety, health, environment, & security regulatory & statutory factors. This is shown on the process map using symbols. This serves as your proof of determination.

awk

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CarolX
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Posts: 124
From:Illinois, USA
Registered: Jun 2000

posted 12 July 2001 10:21 AM     Click Here to See the Profile for CarolX   Click Here to Email CarolX     Edit/Delete Message   Reply w/Quote
This issue came up yesterday during my survelience audit (which we passed with flying colors!!). What my auditor was looking for was our product required to meet certain, specific regulatory requirements, such as NRC, FDA or FAA regulations. Things like OSHA requirements were not part of the scope.

Carol X

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awk
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Posts: 21
From:Ontario, Canada
Registered: Sep 2000

posted 12 July 2001 12:19 PM     Click Here to See the Profile for awk   Click Here to Email awk     Edit/Delete Message   Reply w/Quote

Carol,

After reading your post I realize this issue is deffinitely dependent upon the geographical location of the company.

Our occupational health & safety, which also lists specific environmental issues are regulated by the Ministry of Labour. This is a direct link to job costing and potential Request For Quotes (especially when there are infractions & monumental payouts that are costed in). This then impacts Strategic Planning, for instances when new policies & procedures, etc. need to be established & implemented.

It is great to read the various perspectives.

awk

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energy
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Posts: 308
From:New Britain, CT
Registered: Nov 2000

posted 13 July 2001 10:27 AM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
Carol X,

You refer to “product” meeting legal and regulatory requirements. Your auditor was concerned about “product” meeting certain requirements. As in my previous post, “processes due to statutory or regulatory requirements” is my concern. If you are correct in the assumption it only means that your product, and special processes to accomplish those requirements, must be manufactured to meet some regulatory or legal requirement (FDA, GMP), then my anxiety is for naught. However, in various ISO Awareness and Auditor training sessions, we have been told that Health & Safety-OSHA issues are auditable. I now feel that those issues may become more suitably audited under Sections 6.3 Infrastructure and 6.4 Work Environment.

Here’s a quick example: During the coating operation of our pressure vessels, the employee has to wear a Respirator, per OSHA 1910.134 and is required to follow OSHA 1910.146 Confined Space Entry requirements. So, IMHO, my Auditor may ask to see the records that the company is adhering to OSHA, DEP, etc., regulations and personnel training records showing the employee is authorized to perform those tasks, under the “Work Environment” section of the Standard. Your post made me take another hard look 7.2.1 c) and re-evaluate my thinking. While they may not be auditable under 7.2.1 c), they may be under 6.3 and 6.4.

Thanks for the post and my “new” consternation.

energy


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