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
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