Extension of Certification Scope Requirements

Hi all,

The company I currently work for has three separate divisions, one of which is AS9100 approved, and the other two are ISO9001 approved.

One of the ISO9001 approved company manufactures industrial chains, we currently exclude Clause 7.3 - Design and Development. We do, however, want to extend the scope to include this clause and be able to design and develop 'our' chains.

This will be requested prior to our November audit, however I'd like some advice in how exactly to go around it and if my idea of a way forward is the correct one.

Obviously the auditor will want and need to see evidence that we can comply with the standard requirements and produce the relevant procedures, documents, records and competencies to enable us to include 7.3 into our scope of approval, but we can't do this on a saleable part as we are not approved to do so.

If we were to plan, design and develop a product in the way we would do should we achieve the extension of scope, and be able to provide and demonstrate the exact way that we intend to manage such a project in the future, would this be enough to satisfy the auditors needs, despite us not being in a position to sell the product.

Each product we make is bespoke, and whereas the products are currently 'build to print' jobs we often get requested by potential customers to design the chains ourselves as appropriate for the customers needs.

Any advice/opinion would be greatly appreciated.

Thanks!

You will have to have evidence of a product going through the process. It's insufficient to show "intent". Somehow, you will have to have a requirement - from a customer or generated internally - where you took design inputs and followed your design process until you have a product output (drawings, specs, etc). You may not have anything for sale at that point, but that's OK. Don't forget you made need to make some to validate the design.

Anything else isn't objective evidence...

Thanks Andy, that's what I was trying to get to - but maybe in a bit of a long-winded way,

But if we weren't to have a customer order, could we design and manufacture a product in-house, with all the relevant validations and use that as our 'sample'.

Alternatively, not all of our customers request ISO9001 release, therefore would it be a possibility to actually receive an order where ISO9001 release wasn't requested, and actually design the product as we would with an ISO release product and sell it, using that as a sample?

pearson114 said:

But if we weren't to have a customer order, could we design and manufacture a product in-house, with all the relevant validations and use that as our 'sample'.

Alternatively, not all of our customers request ISO9001 release, therefore would it be a possibility to actually receive an order where ISO9001 release wasn't requested, and actually design the product as we would with an ISO release product and sell it, using that as a sample?

Click to expand...

I have two answers:

Yes, it's fine to run your own product without having any end customer. Indeed, I came from an org. which often did that - they needed something to show customers before they knew they needed it!

Secondly, you should be running your QMS all the time, regardless of whether a customer requires an "ISO9001 release". That sounds like a "hang-over" from the 1994 days of the standard... in any case, just run your process, as mentioned above.

Thanks Andy,

Again - maybe I wasn't quite clear enough, we run our QMS at all times, despite some customers not requesting ISO release.

The question to deviate from the QMS was purely just to try and get the sample together for a customer who does not require it. But without causing further confusion I think the best and easiest way would be to design and manufacture a product in-house which is not intended for sale.

Thanks for your help!