Practical interpretation of the requirements of the ISO 13485:2016 standard

The ISO 13485 standard prescribes the requirements of a quality management system which can be applied by organisations interested in one or more stages of a product ‘s lifecycle. As opposed to misconceptions, ISO 13485 can be used not only by producers of medical devices but by authorised representatives, importers, distributors, service centres or even external partners who deliver goods or provide services for the organization.

ISO 13485:2016 is harmonised with both MDR and IVDR, therefore, it is an essential element of fulfilling the regulatory requirements for manufacturers supplying the European market.

Like every standard, the ISO 13485 only prescribes concise and straightforward requirements, the practical interpretation thereof causes difficulties, especially for start-ups wishing to join the medical sector.

Working group ISO TC/210 elaborated on the requirements of ISO 13485 in their publication entitled “A practical guide ISO 13485:2016 Medical devices” issued back in 2017.  This guideline describes the concepts and methods, which can be applied in the development, implementation and maintenance of the quality management system. The guideline follows the structure of the 13485:2016 standard, contains requirements of the standard as well as presents the purpose of the given phase, subsequently drawing up exact practical advice

Several points of the guideline refer to the documents of the International Medical Device Forum (IMDRF), including the documents of the already dissolved Global Harmonization Task Force (GHTF). The GHTF documents can be downloaded from the website of the IMDRF free of charge, thus they can be easily used for practical interpretation. The GHTF documents referred to in the practical guidance to ISO 13485 are as follows:

·        GHTF SG3 N15R8 - Risk Management Principles and Activities within a QMS - May 2005

·        GHTF SG3 N17:2008 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008

·        GHTF SG3 N18:2010 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010

·        GHTF SG3 N99-10:2004 - QMS - Process Validation Guidance - January 2004


The publication “A parctical guide ISO 13485:2016 Medical devices” should be compulsory literature for every quality expert, auditor and advisor, nevertheless it has only been read by few and applied by even fewer. 

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