Where is the definition of a critical supplier?

JP12345

Involved In Discussions
#1
We were recently asked during a surveillance audit if we have any 'critical suppliers'. I can't find any reference to critical suppliers in the MDD,MDR or ISO 13485. Can anybody point me to where this term is defined or where the requirement is to define your critical suppliers?

Thank you for any help with this
 
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LUFAN

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#3
Rob Packard has a good article on this:

The points above help identify the limitations of supplier metrics. In the end, if you have a critical supplier—there is no substitute for auditing them. Unfortunately, auditing costs money. So which suppliers should you visit?​
The “critical suppliers” is often the answer, but how do you decide who is critical? Well, …benchmarking is a good idea. For example, a Notified Body (NB) must audit “critical suppliers” that do not have ISO 13485 certification. They define “critical” as subcontractors that perform high-risk processes, such as contract sterilization, subcontractors that perform contract packaging and suppliers that manufacture finished devices. Health Canada even provides some guidance on the definition of critical subcontractors, and how the NB shall determine which “subies” need to be audited.​
Internally, your supply chain and quality assurance team have to develop a list of suppliers that will be audited. In general, I recommend that all “critical” suppliers be audited at least once every three years (equal to the certification cycle). However, your auditing schedule is a plan that should have “wiggle room.”​

 

Jean_B

Trusted Information Resource
#4
There's also a critical supplier definition in the MDSAP companion document to which people might hold you, as well as suppliers of components which would be marked as critical components by a testlab certifying against IEC 60601 (that is the overly specific context for what often leads to the naming of an inordinate amount of critical suppliers).

To be honest, given what everyone has been putting as criteria for when something is critical you'll turn into a quality consultancy company if you're indiscriminate. Even the formulaic "if critical then audit" is untenable. There must be controls, but properly tuned SPC, QC, process validation, self-testing designs, system interlinking, certificate of analysis etc have just as much if not more of a place in supplier control than audits.
 

somashekar

Leader
Admin
#5
We were recently asked during a surveillance audit if we have any 'critical suppliers'. I can't find any reference to critical suppliers in the MDD,MDR or ISO 13485. Can anybody point me to where this term is defined or where the requirement is to define your critical suppliers?

Thank you for any help with this
There is no such word as 'critical suppliers' in the 7.4 of the ISO 13485.
However you will see that one of the criteria for evaluation and selection of supplier is to assess the proportionate risks associated with the medical device that could come from the selected supplier.
If you have applied this criteria to your context, you will obviously have few suppliers who would be 'critical suppliers' to you.
Now see the clause 0.2 (clarification of concepts) - When the term "risk" is used.
Hope you have the clarification now....
 
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