Supplier Audits
Supplier Audits for the Medical Device Industry
A supplier audit is performed by businesses to ensure that the external supplier meets the organization’s quality standards. In a supplier audit, the auditor inspects if the supplier is adhering to the industry regulations (ISO 13485:2016 or ISO 9001:2015) and practices such as health and safety measures and correct manufacturing processes.
Monitoring a supplier’s performance requires constant assessment of product quality, cost, and compliance. Why is this important for medical device manufacturers?
1) Minimizes risk
2) strengthens relationships
3) Stay compliant
4) Maintain safe supply chain
1) Minimizes risk
2) strengthens relationships
3) Stay compliant
4) Maintain safe supply chain
Supplier management is the practice of selecting, evaluating, qualifying, and monitoring suppliers.
For medical device companies selling their products in the US market or the EU (European Union), supplier quality management is a core requirement as per regulatory requirements. Both the US FDA (specifically, FDA 21 CFR 820.50, and ISO 134585:2016, Section 7.4 explain in detail supplier evaluation.
We also need to understand that medical device supplier quality management is not just a regulatory requirement, but a crucial business practice. Companies operating in the medical device industry need to ensure that the suppliers chosen are up to industry standards.