ISO publishes handbook of quality management system guidance for ISO 13485:2016

New publication provides additional support for transition to the new edition of the key QMS standard for medical devices

The International Standards organization (ISO) has published an ISO Handbook of guidance on ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes. It is titled ISO 13485:2016 – Medical devices – A practical guide. ISO 13485:2016 was adopted in Europe as EN ISO 13485:2016.

The ISO Handbook was written by a task group of technical experts from the ISO committee responsible for ISO 13485. The Handbook incorporates the text of all the clauses of ISO 13485:2016 and then gives clause-by-clause guidance intended to assist with the application of the standard. It does not define any additional requirements nor add to or otherwise change the requirements of ISO 13485. The guidance describes concepts and methods to assist in the development, implementation and maintenance of a quality management system (QMS). It is intended to be applicable across the lifecycle and supply chain of medical devices. The Handbook has taken into consideration guidance contained in a wide range of QMS documents from a variety of sources. The guidance contained in the Handbook is intended for educational purposes. It is not to be used to assess compliance with regulatory requirements nor to be used for identifying specific non-conformities in a QMS. This ISO handbook replaces ISO Technical Report 14969:2004, Guidance on the application of ISO 13485:2003.

This ISO Handbook provides an additional resource to support making the transition to the new edition of the standard. It also helps with interpretation of the requirements. Assessment Bodies are also providing materials to support the transition. BSI have made a range of resources available, including webinars, white papers, expert commentaries and frequently asked questions.

This new publication comes midway through the three-year transition period from the previous edition of the standard. The transition period ends at the end of February 2019. Pressure on organizations to transition is increasing. You should check that you are still on track with implementing your transition plan. If you have not yet started making the transition, you need to begin as a matter of urgency or you risk losing your certification to EN ISO 13485.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.