ISO 13485: Selecting Suppliers and staying compliant

Nothing is simple in the beginning for a supplier and selecting a supplier is one of them. The organization must establish criteria for the evaluation and selection of suppliers. For a start-up company with an innovative product, this can be problematic as choices for suppliers may be limited.  Parts may only be available from a single/or sole source or suppliers/parts may be tied to a product regulatory clearance or approval.

Moreover, some suppliers refuse to work with companies with low or no revenues. Careful consideration in defining the supplier approval criteria is needed to assure that you do not inadvertently eliminate all potential suppliers.

Note per the requirements, the criteria shall be based on a) the supplier’s ability to provide product that meets the organization’s requirements; b) performance of the supplier, c) effect of the purchased product on the quality of the medical device and d) proportionate to the risk associated with the medical device.

If you need help with setting up criteria, contact us at Conformity Tech.

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