Interpreting clause 4.1.5 in ISO 13485:2016

SteveK

Trusted Information Resource
#1
“When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes.”

Now I can see that sending an item to be e.g. anodized by an external company is an example of outsourcing a process. However, in this context does “process” also mean using an external company to supply moulded parts, machined components, PCBs etc .to your design for assembly into the final device at your production site? By answering my own question – I assume it does. It is just that now the requirement of this clause is to obtain written supplier agreements. In our case we have enough problems getting supplier quality questionnaires returned as part of our vendor approval process (no problems with major ones) – noting that we have hundreds of suppliers! Can anyone confirm my assumption?

Steve
 
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Pads38

Trusted Information Resource
#2
I don't think that this necessarily applies to ordinary 'Parts Suppliers'. Anyway, you can maintain quality control simply by inspection of the supplied parts, or the quality of the anodising.

Rather, I think this is more related to out-sourcing design and all manufacturing to third parties. The named 'manufacturer' must have full control of all critical aspects and not just be "putting their sticker" on a box.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#3
I'm not in the medical field but it would seem to me things like getting a simple C of C from the supplier, supplier audits, checking on supplier certifications (i.e. NADCAP), doing sampling inspection on incoming items, and those questionnaires you mention are all relatively common methods of complying with that clause.
 

rob73

looking for answers
#4
I would agree with pads that this is how we would like it, but thinking about pip scandal, what if your supplier swapped your expensive medical grade HDPE for a knock-off 50% recycled material to improve his profit margin. Would you be able to tell the difference? for an invasive device this would have a massive impact on conformity, telling the auditor "we've worked with then for many years and trust them" may not pull any weight.
Does anyone know if there is going to be an update TS14969 for 2016??
 

yodon

Staff member
Super Moderator
#5
“When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes.”

Now I can see that sending an item to be e.g. anodized by an external company is an example of outsourcing a process. However, in this context does “process” also mean using an external company to supply moulded parts, machined components, PCBs etc .to your design for assembly into the final device at your production site? By answering my own question – I assume it does. It is just that now the requirement of this clause is to obtain written supplier agreements. In our case we have enough problems getting supplier quality questionnaires returned as part of our vendor approval process (no problems with major ones) – noting that we have hundreds of suppliers! Can anyone confirm my assumption?

Steve
Don't forget the rest of the story:

The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements...


(I'm trying to come up with an Obi-Wan type line of "Steve, use the risk" but it's just not working :) ). A statement of work or purchase order could certainly serve as written quality agreement (if you include quality requirements). Questionnaires certainly aren't required.
 

Access2hc

Involved In Discussions
#6
hi - it means as far as possible to have written down an agreement of the mutual expectations and requirements.

it's good business sense - how can you not have an agreement/contract when you outsource anything that can affect the product or the QMS?

the current version just stated the need for written agreement so that there's no disagreement or ambiguity down the track.

Cheers,
Ee Bin
 

bjohnsonrli

Starting to get Involved
#7
Hi Steve,

It looks like ISO has taken what was a "thou should" to a "thou shall" type of situation. Adding a quality agreement requirement brings the standard in line with EU GMPs and with the guidelines FDA has accepted.

Quality agreements have been a requirement by the FDA....

21 CFR 820.50 Purchasing Controls
"...Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device..."

Chapter 7 of the EU GMPs talks about Outsourced Activities and requires a quality agreement to define the responsibilities of the "contract giver" and "contract acceptor."

I agree with you about the difficulty in getting simple signed documents back from suppliers. However, we have taken the approach to have agreements in place with vendors of "critical" materials (or processes) and ones who supply large quantities of raw material. The rest are categorized as "miscellaneous" so that we aren't wasting time trying to get the janitorial company to sign an agreement. We put all this in our supplier evaluation procedure and perform audits accordingly (Periodic onsite audits, incoming quality controls, on going reliability testing, process change approval, etc.).
 

SteveK

Trusted Information Resource
#9
Steve, in my interpretation, it doesn't. What you are describing is not outsourcing of a quality-impacting process, but simple procurement of parts, covered under section 7.4 of ISO 13485:2016.
Hi Sidney,

Thanks for that - the more I have been looking at the definition of a 'process" wrt clause 4.1.5, I do think that you are right and that my initial assumption was wrong. It is just that in trying to out-think an auditor's and NB's possible interpretation of such clauses that I keep potentially heading down a black hole!

Steve
 
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