In addition to conducting internal audits, ISO 13485:2016 requires monitoring and (re)evaluating suppliers. Supplier audits have the advantage of not only checking the normative and regulatory requirements, but also ensuring that individual specifications and agreements are adhered to.

To assess and select your suppliers, you must set assessment criteria that meet your requirements, reflect the supplier’s performance, consider the impact on the medical device and match the risk associated with the medical device. Suppliers may be under separate observation due to their performance as a critical supplier or the supply of critical components. In both cases, it is advisable to monitor suppliers through regular audits. If you outsource value-adding processes to an external partner who does not maintain their own quality management system, you are under an obligation to monitor the process.

Supplier audits help you to identify and appropriately address non-compliance with procurement requirements. Plan regular supplier audits with critical suppliers to ensure that outsourced processes and critical components meet your regulatory requirements.

Supplier audits should be planned early with and communicated to the supplier. The possibility of carrying out supplier audits and the frequency of audits should be laid down in quality assurance agreements. By law, the supplier is not obliged to accept supplier audits. In your quality assurance agreement, also make sure that suppliers agree to an audit as part of your certification or to a surveillance audit by your notified body.

Take advantage of the expertise of our experienced auditors and receive objective evidence that your supplier’s quality management system fulfills the audit criteria. As an independent third party we can give you an unbiased evaluation of the status of your suppliers.