ISO 9001 Cert Scope Adjustment

[Ed Panek]

We are a company that has two products. One is a battery we make using thin film under our 9001 QMS. The other is a wearable temperature patch under 21 CFR and ISO 13485 as a medical device. Our battery is a critical supplier to our medical device.

We had our 9001 surv audit today and the auditor wanted to adjust our cert scope from "Design and manufacture of thin film batteries" to "Design and manufacture of thin film batteries excluding medical devices" They stated it was to prevent liability and confusion.

Myself and our CEO refused the change as it would be confusing to customers who wanted to use our battery in their medical devices. My perspective is the QMS is being audited; not the specific products we make and to add that exclusion in our scope if unfair as its only added because we also manufacture medical devices. I also stated that scopes should positively define the certificate; not exclude items from certification.

Comments?

 

[Sidney Vianna]

Comments?

This is a discussion to be had with the CB Technical Manager, not the auditor. In principle, I don’t see any problems for the scope of certification to be left unchanged or refined to something such as D&M of thin film batteries for medical device applications.
For the auditor to propose the exclusion when he knows the batteries are used in medical devices is preposterous and fraudulent. Apparently in his mind there is a derrière to be covered.

 

[Ed Panek]

Thanks

 

[Funboi]

Not the auditor’s job. I’d write a complaint to your CB about the auditor and tell them you don’t want them back.

 

[Randy]

For the auditor to propose the exclusion when he knows the batteries are used in medical devices is preposterous and fraudulent. Apparently in his mind there is a derrière to be covered.

Or it might be part of a corrective action related to an AB nonconformity over scope specificity

 

[Tagin]

They stated it was to prevent liability and confusion.

1) An 9001 QMS auditor's scope does not include legal determinations and so should not be providing guidance on what causes 'liability'. They are also presumably not a licensed lawyer, and so are on that basis also unqualified to make such arguments.
2) The auditor needs to cite a specific violation or inadequate coverage of a 9001:2015 clause. They cannot simply claim possible 'confusion'. Your scope currently adheres to clause 4.3 as far as I can see.

 

[Sidney Vianna]

Or it might be part of a corrective action related to an AB nonconformity over scope specificity

Even worse. Scope statements cannot be deceiving. If the batteries ARE used in medical devices, for the auditor to propose something that is contrary to that, is a fraud in my estimation. Very likely there is a concern over the ISO 9001 auditor competence to audit NACE Code 39(?) and someone is engaged in an attempt to cover their you know what.

 

[Funboi]

Really doesn’t matter what conspiracy theory is behind the auditor’s statements. Not their job. Complain.

 

[Ed Panek]

He also stated that our quality objectives cannot mention by name our only customer and that we need to keep the two QMS completely separated. For example from "Achieve less than 5% reject on (customer named product) in their production line" to "Achieve less than 5% on _ANY_ customer usage of battery."

We only have one customer; OURSELVES.

 

[malasuerte]

He also stated that our quality objectives cannot mention by name our only customer and that we need to keep the two QMS completely separated. For example from "Achieve less than 5% reject on (customer named product) in their production line" to "Achieve less than 5% on _ANY_ customer usage of battery."

We only have one customer; OURSELVES.

Pretty bad on both takes. Your scope statement is yours alone; and fine imo. Quality objectives can most certainly have the customer named. This is the whole premise of a Foundry - multiple customers all with different requirements/quality objectives.