Vendor/Supplier Evaluation

The method of evaluating suppliers can be either done via physical/site audit or desktop audit.

The type and extent of control applied to the supplier shall be dependant upon the effect of the product on product realization (final product). Rather than evaluating all suppliers, use a risk based approach. When desktop audits are performed, ensure that they record any certification the organisation has and that you maintain a current certificate. There have been many instances where organizations have been caught out by regulators for not having the updated supplier certificate. Supplier re-evaluation should also be performed; this can be as simple as asking for an updated registration certificate. When a supplier has no certification, use history of supply as grounds for approving the vendor.

About CMS:

Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.