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

[James Gutherson]

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.

 

[ikar]

"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.

 

[awk]

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

 

[CarolX]

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

 

[awk]

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

 

[energy]

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

 

[Claes Gefvenberg]

Note to Amber: I split your post (and Samers reply) about ISO Awareness training off to a new thread.

/Claes