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This thread is carried over and continued in the Current Elsmar Cove Forums
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 The New Elsmar Cove ForumsThe Elsmar Cove Forums
 ISO 9001/4:2000
 7.2.1 (c) Statutory & Regulatory Requirements
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| Author | Topic: 7.2.1 (c) Statutory & Regulatory Requirements |
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Russ Forum Contributor Posts: 31 |
posted 11 July 2001 08:43 AM
   
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? IP: Logged |
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SteelMaiden Forum Contributor Posts: 35 |
posted 11 July 2001 08:59 AM
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 IP: Logged |
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energy Forum Contributor Posts: 308 |
posted 11 July 2001 01:26 PM
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 IP: Logged |
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James Gutherson Forum Contributor Posts: 43 |
posted 11 July 2001 08:26 PM
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. IP: Logged |
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ikar unregistered |
posted 12 July 2001 04:57 AM
"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. IP: Logged |
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awk Forum Contributor Posts: 21 |
posted 12 July 2001 08:27 AM
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 IP: Logged |
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CarolX Forum Contributor Posts: 124 |
posted 12 July 2001 10:21 AM
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 IP: Logged |
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awk Forum Contributor Posts: 21 |
posted 12 July 2001 12:19 PM
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 IP: Logged |
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energy Forum Contributor Posts: 308 |
posted 13 July 2001 10:27 AM
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. Thanks for the post and my “new” consternation. energy IP: Logged |
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