ISO 13485:2016 strengthens the control of suppliers in the Medical Devices Industry

The 2016 revision of the ISO 13485 standard introduces a more stringent approach to the control of critical suppliers. The concept of supplier control is not new to ISO 13485; as it is already widely applied in regulatory schemes including the Medical Devices Sector. The revision will however affect the manufacturers who are subcontracting critical parts of the production process and significantly increase their duties.

ISO 13485:2016 targets three main aspects concerning the control of external parties, e.g. suppliers, subcontractors, consultants, etc.:

1) Manufacturer is obligated to keep a more elaborate documentation concerning the outsourcing procedure

2) ISO 13485:2016 standard applies stricter criteria for supplier evaluation and selection

3) International standard further integrates and implements a risk-based approach to the matter of supplier control

The aim behind the 2016 ISO 13485 revision is twofold. On one hand, the reinforced control of suppliers is introduced to create a higher degree of harmonization among the Quality System regulatory requirements. On the other hand, ISO 13485 intends to ensure a higher level of compliance with regulatory requirements among organizations.

As an ISO 13485:2016 certified company and trusted operator in regulatory matters, Obelis is happy to assist you with any of your regulatory enquiries – contact us to ensure your products’ compliance.

Hannah Van Deun

in News