Suppliers are obviously a critical component of your business.  Thus, when things start to go poorly, it’s not just their problem – it’s your problem.

There are a variety of reasons why medical device suppliers could get booted from your Approved Supplier List but, quite often, the manufacturer-supplier relationship goes south over issues involving product quality and missed delivery time frames. That’s why ongoing monitoring is so important as a tool to head off serious supply issues.

Regardless of how many suppliers you have, it’s vital (and required by ISO 13485) that you monitor their performance and conduct regular evaluations.…

When purchased products arrive at your facility, you need to confirm that they meet the requirements established in your quality agreement.

What’s the best way to go about that?

First, consider the risk associated with the purchased product and then examine any actions the supplier has already taken to verify compliance.

Choosing the right verification method is a risk-based decision and there are a variety of methods available.

These include:

• 100% inspection
• Sampling inspection
• Skip-lot testing
• Assessment of pre-shipment samples
• Acceptance on Certificate of Analysis/Conformance

Spotty quality. Price increases. Poor reliability. There are myriad reasons why medical device suppliers go from “approved” to “disqualified” on your Approved Supplier List.

Regardless of how many suppliers you have, it’s important (and required) that you monitor their performance and conduct regular evaluations. This will allow you to make informed business decisions, spot performance issues before they worsen, uncover waste, and facilitate supplier performance. The most effective supplier evaluation programs are risk-based, continuous, supplier supported, cross-functional, visible, and accountable.

Once you have established what you are purchasing and what type of supplier you need, it’s time to find qualified partners. The goal here is to plan and implement a consistent, risk-based approach for engaging new suppliers.

It is important (and required in ISO 13485:2016) for you to have documented procedures, supplier evaluation and selection criteria, and a record of supplier evaluations you have performed along with subsequent actions. Section 7.4.1 of ISO 13485:2016 combines the words evaluation and selection, but these are actually separate activities.…