Can this be a case for Design and Development Exclusion

[Jan T]

Good day all

I work for a manufacturing concern, and our products are inter alia flameproof alternators and lighting for the mining industry. We are currently upgrading into I/S intrinsically safe products. So we are being audited by Sira and IECex for exporting.

Products are designed,drawings done by my bosses, owners of business,design and drawings are send to ATL (test lab)and after approval we start production.

Question : Can I exclude Clause 7.3 Design and Development ?
I am not sure who does the development, prototype etc.

Hi Andre;

I just have a few quick questions. You state that the products are designed and drawings done by your bosses. Where do they get the information needed to do the design of the product? Are the drawings ever revised? Is there and existing work instruction or procedure in your company at this time that details how this process is achieved? Customer communication thru to production of the designed parts?

Regards
Jan

 

[Andre Venter]

Hello Harry

Thanks for your answer, I have a page or so back quoted from the link you have provided.

 

[Andre Venter]

Hello Howste
These are technical drawings, which were approved along with the specific product,by a lab and these were then certified by a registered CB.

Our product certification clauses state that neither the drawings or the product can be changed or modified without prior approval of the CB or the ATL.

 

[Andre Venter]

Hi Andre;

I just have a few quick questions. You state that the products are designed and drawings done by your bosses. Where do they get the information needed to do the design of the product? Are the drawings ever revised? Is there and existing work instruction or procedure in your company at this time that details how this process is achieved? Customer communication thru to production of the designed parts?

Regards
Jan

Hello Jan

There are no procedures,WI or any other documents about design as we have always excluded it from our scope. There is no customer specifics about our catalogue products, they were as far as I can gather been designed by the company owners and directors, but in accordance with an ATL and a CB. We do however adhere and comply to all regulatory spec's.

 

[mmagargee]

Good day all

I work for a manufacturing concern, and our products are inter alia flameproof alternators and lighting for the mining industry. We are currently upgrading into I/S intrinsically safe products. So we are being audited by Sira and IECex for exporting.

Products are designed,drawings done by my bosses, owners of business,design and drawings are send to ATL (test lab)and after approval we start production.

Question : Can I exclude Clause 7.3 Design and Development ?
I am not sure who does the development, prototype etc.

I apologize in advance for responding to a stale thread, but the issue regarding the appropriateness of excluding design activities from an IECEx audit should reference the appropriate standard. That audit will be done under ISO/IEC 80079-34 (back at the time of this thread it would have been EN 13980) and both standards exclude that activity from the scope. See 80079-34, 7.3.1 - 7.3.6. Those six sub clauses state, "subclause 7.3.x of ISO 9001:2008 is not within the scope of this standard." However, clause 7.3.7 of 80079-34 states that sub clause 7.3.7 of ISO 9001:2008 does apply and adds the requirement for an EX person to approve design changes. Also, many IECEx manufacturers have parallel ISO 9001 certifications, and of course this thread went into great detail about being able to exclude design from those certifications.