The Key Changes of the New ISO 13485:2016

ISO 13485 is the internationally recognized quality management systems standard for the medical device industry.

Major changes of ISO 13485:2016 include:

• Quality Management System (QMS) – All processes that are part of a manufacturer’s QMS will now need to be developed using a risk-based approach. Any software used as part of the quality system should be validated and documented.
• Management Responsibility – Clarifications of existing requirements regarding quality management system planning, responsibility and authority, as well as management representation and review.
• Resource Management – Device manufacturers must define the skills and experience required for personnel involved in the maintenance of the QMS. A new clause also addresses contamination control and processes for sterilization.

For more information about the changes, see our ISO 13485:2016 fact sheet (.PDF).

Why it’s important:

In the EU, the requirements of ISO 13485 have been harmonized with the essential requirements of the EU’s Medical Device Directive (93/42/EEC), the Directive for In Vitro Diagnostic Medical Devices (98/79/EC) and the Directive for Active Implantable Medical Devices (90/385/EEC). Certification to ISO 13485 by an accredited certification body provides a presumption of conformity with the essential requirements of these important directives. In the U.S., the Food and Drug Administration (FDA) permits device manufacturers to submit ISO 13485 audit reports as a substitute of the evidence of compliance with its quality systems regulations (QSR). Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO 13485.

Your Updated Certificate

Since the official publication of ISO 13485:2016 on March 1, 2016, the transition of accredited certifications to the new ISO 13485:2016 can now be affected within the scope of a regular surveillance or re-certification audit. If the transition is carried out within the scope of a surveillance audit, additional audit time needs to be scheduled.

Manufacturers of medical devices and other organizations that hold an ISO 13485 certificate should therefore address the requirements of the new standard without delay, so that they can assess the extent of the changes that they need to implement in their existing quality management system and the time needed for said implementation.

Read more about ISO 13485:2018

Training Course

• ISO 13485:2016 Internal Auditor Training - 3 days

Certification Services

TÜV SÜD's Quality Management auditing certificates show that you comply with the requisite international standards such as ISO 13485. Learn more about our services.