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Supplier evaluation and business needs in the context of ISO 13485


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Hi everyone,

When qualifying suppliers in the context of 13485, I understand the risk-based approach. However, as regulatory/quality professionals, we tend to think of risk from a quality perspective. What about business risks? If the supplier is a single-source supplier of non-critical components, how can we control this supplier? What if it's a single-source supplier of critical components? Are all single source suppliers considered critical suppliers? I don't expect that we would request the same set of documents from single-source suppliers of non-critical components that do from single-source suppliers of critical components. Please clarify.



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Just to note, the terms "critical supplier", "critical provider", and "critical component" do not appear in either 13485:2016 or 9000:2015.

I don't think you can really control suppliers in terms of business risks, aside from 1) contractual agreements, or 2) business leverage (i.e., as a customer you are a large percentage of their business, and thus can wield a big stick.)

Even with contractual agreements, if they go out of business the contract will not help you get product. So, I'd think you'd want to perform more up-front evaluation of the supplier's longevity, industry reputation, financial health, etc.
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