The guidance contained in the Handbook is intended for educational purposes. The Handbook has taken into consideration guidance contained in a wide range of QMS documents from a variety of sources.
It is intended to be applicable across the lifecycle and supply chain of medical devices. The guidance describes concepts and methods to assist in the development, implementation and maintenance of a quality management system (QMS). It does not define any additional requirements nor add to or otherwise change the requirements of 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.
The ISO Handbook was written by a task group of technical experts from the ISO committee responsible for ISO 13485. It is titled ISO 13485:2016 – Medical devices – A practical guide. 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. New publication provides additional support for transition to the new edition of the key QMS standard for medical devices
