Statutory and Regulatory Requirements - How to address 7.2.1c

[ivan99]

I apologize for reopening this discussion, but after I read all the discussions, I am still uncertain on how to address this sub-clause.
The 9001-2000 std states:
"The Organization shall determine:....
c) statutory and regulatory requirements related to the PRODUCT...)
My questions:
1- For those who are certified already to 9001-2000, how did your auditors approach this? What proof did they ask for to verify your compliance?
2- We are in the nameplate industry (labels, nameplates etc...), the only regulatory requirements we know of are for UL, CSA and American Gas. Our order takers are not aware of any laws governing the label/nameplates industry. We have industry standards and practices published by SGIA and that is all !!
This requirement creates extreme hardship and expenses (to research all applicable laws and regulations) on small companies like mine.
Any help is much appreciated...Thank you in advance.

 

[Jimmy Olson]

Ivan,

I'm not sure if this will help, but I figured I would tell you how we handle this. We are a contract manufacturer for circuit boards. Our customers are responsible for the design, but we supply a document that we created to give guidelines for manufacturability to our customers. These guidelines are based on industry standards, but are translated into something a little more understandable for our customers.

During our audit this question never came up directly. The auditor looked at our manufacturability guidelines and also saw that we incorporate the requirements into the inspection process. I hope this helps at least a bit. Let me know if you want me to explain anything a bit more, or if there is other information I can help with.

 

[Bruce Wade]

A few possible examples:

(Forewarning: We have an integrated ISO 9001:2000 and ISO 14001 management system. The regulatory requirements of many examples may be blurred between these two standards...)

If the process requires or generates hazardous waste, appropriate documentation is required for acquisition/disposal.

If use of the final product requires permits or special handling, these regulatory requirements may/must be communicated to the Client prior to production/distribution.

If services provided require permitting, acquiring and documenting the permits is required.

Another example from here: We produce mass mailed printed pieces. As such there are USPS regulations governing the size and weight restrictions, and corresponding postage rates.

And so on...

Yes, our registrar does examine our documentation and records for these types of regulatory requirements. But, then again, they always did in response to ISO 14001 certification requirements. The requirements in ISO 9001:2000 only add to the intensity...

 

[Edith]

Funny you should ask...

Hi there!

This element really TICKED me off. We have been certified to the 2000 standard for a year now, and the auditor seemed to just zone in on this one element.

He wanted to see how we effectivley went through certain governement documents to validate the projects we were working on. Just so we knew what we were doing. Your external documents list should give you some ideas.

Good luck~!
Edith

 

[Carl Exter]

Our registrar hasn't really honed in on this situation. We design, manufacture, and distribute electrical power products. As such we have UL and CE regulations and standards to follow. We have the standards controlled in our engineering department for their reference during design. But ultimately, UL has the final say-so on whether or not we meet the regulatory requirements.

Obviously, we don't depend on them to verify or validate our designs, but they do cover our butts I guess from legal requirements when they bless a new design and give it the UL seal of approval, so to speak.

I think that if an auditor wanted to see that we control our regulatory requirements, we could provide data to the effect of # of submissions for UL approval vs. # of approvals vs. # of rejections where we had to redesign something. This would show that we control the standards and requirements as if we weren't, we have a high reject/ redesign rate as opposed to a high first-time approval rate.

Hope it helps.