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Customer Related Processes and Requirements - ISO 13485 Clauses 7.2.1 and 7.2.2

Morlock

Involved In Discussions
#21
By ISO 13485 definition we are a "contract manufacturer", so this is the terminology I used. Correct, we provide R&D services in that we apply different coatings in different manners to produce different results, but it is the customer who determines the needs and acceptability of the performance of the coating, and they provide all of the substrate and are responsible for all upstream and downstream processing. Our scope is typically fairly limited with regards to the entire device lifecycle.

After the customer is satisfied with the R&D outputs, we obtain a drawing for the final "coated-level" spec for the component, containing information such as coating components, coating length, lubricity specifications, FM specifications, etc. This customer-supplied drawing is held in our QMS as a reference document, and is approved by Engineering, Manufacturing, and Quality. Any revision to this document by the Customer is reviewed by us and requires approval within our QMS prior to manufacturing to the revision.

When manufacturing, this reference drawing (and revision) is checked after each customer order is placed, and if there are any discrepancies, they must be resolved prior to continuing with the processing of the order. All orders are reviewed and approved by Manufacturing.

To me, this satisfies the "records of evaluation of customer requirements" criteria. Is that too simplistic?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#22
It sounds OK for the manufacturing side (assuming the review by manufacturing covers all relevant aspects, including e.g. availability and timeframes, not just tech specifications), but downplaying the R&D service doesn't change the essence of the situation on that side. If you provide such a service, there must be an upfront documented review addressing that activity/service - that's my reading of the standard.
 

Morlock

Involved In Discussions
#23
That's fair. I would think our test protocol reports (which include feedback from the customer), and which are approved within our QMS, would suffice the "upfront document review" regarding the R&D activity.

Does the ISO requirement require us to document all of this for every order placed by every customer? It seems like it would be redundant, especially with routine customers (customers placing the same order quantities for the same parts with the same coating specs...) If so, what might be a quick and efficient way to document the review of specs, availability, timeframes, etc.?

We are a small job shop, and the base units are supplied by our customers, so line availability and unit availabilty aren't really an issue. The lead times are listed on the quotes, which are approved in house and by the customer. We coat however many parts they send us (quantity is also listed on the Purchase Orders), so inventory isn't an issue...

I am waiting to hear back from the auditor to further clarify what they were looking for, and what the shortcomings were...

Thanks for the help.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#24
It sounds OK for the manufacturing side (assuming the review by manufacturing covers all relevant aspects, including e.g. availability and timeframes, not just tech specifications), but downplaying the R&D service doesn't change the essence of the situation on that side. If you provide such a service, there must be an upfront documented review addressing that activity/service - that's my reading of the standard.
In terms of certification to the ISO 13485 standard, the registrant still has the latitude to limit the scope.

If they do not want to have the R&D support service as part of the scope of certification and include only the contract manufacturing part of the business, they are allowed to do so.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#25
In terms of certification to the ISO 13485 standard, the registrant still has the latitude to limit the scope.

If they do not want to have the R&D support service as part of the scope of certification and include only the contract manufacturing part of the business, they are allowed to do so.
Fair enough. Did they?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#26
I would think our test protocol reports (which include feedback from the customer), and which are approved within our QMS, would suffice the "upfront document review" regarding the R&D activity.
Sorry, I don't understand how this is related to my previous post. Please note that I wrote "upfront documented review", not "upfront document review". It's not necessarily a review of documents. Rather, the point was that it has to be recorded (documented), as opposed to a chat at the lunchroom (which might also qualify as a review - depending on the contents), and it has to be upfront, i.e. before the order is accepted (or before a quote is issued).

The review I thought of was more about understanding what R&D services - in some reasonable detail - the customer is asking for / needs in the specific instance, verifying that the understanding was correct, making sure you have what's necessary in the specific instance (all aspects - knowledge, tech, resources etc.), communicating back any assumptions, exclusions, limitations etc. etc...

Does the ISO requirement require us to document all of this for every order placed by every customer? It seems like it would be redundant, especially with routine customers (customers placing the same order quantities for the same parts with the same coating specs...) If so, what might be a quick and efficient way to document the review of specs, availability, timeframes, etc.?
In my understanding - yes, for every order. Even if the orders are identical, your situation might be different, for 1001 reasons. This might or might not be significant, but if you don't review, how will you know? Maybe have a checklist to quickly go over all aspects, and for each aspect where nothing is different (including circumstances and outcomes) just note "same as order XXX". The point is to actually have a review held, and have the record on file. If later there are any issues, you can trace back, identify root causes, initiate CAPA if warranted, etc.

We are a small job shop, and the base units are supplied by our customers, so line availability and unit availabilty aren't really an issue. The lead times are listed on the quotes, which are approved in house and by the customer. We coat however many parts they send us (quantity is also listed on the Purchase Orders), so inventory isn't an issue...
Good, that means your review should be easier. Additionally, It might make sense to begin the review before a quote is submitted (maybe capture the reasoning behind quoted lead time etc.), then quickly revisit and finalise before accepting an order.
 

Morlock

Involved In Discussions
#27
Fair enough. Did they?
R&D is not within our scope of certification, only manufacturing.

Please note that I wrote "upfront documented review", not "upfront document review". It's not necessarily a review of documents. Rather, the point was that it has to be recorded (documented), as opposed to a chat at the lunchroom (which might also qualify as a review - depending on the contents), and it has to be upfront, i.e. before the order is accepted (or before a quote is issued).
That's fair. I see the difference.

Maybe have a checklist to quickly go over all aspects, and for each aspect where nothing is different (including circumstances and outcomes) just note "same as order XXX". The point is to actually have a review held, and have the record on file.
Might you have a template, or know if there is a template in the forum? I've searched a little, and will keep searching, and I can update/link it here if I find one.

Again, thanks to everybody for the continued discussion. It is very enlightening for me.
 
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