WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Manufacturer obligations: essential principles, technical documentation, clinical evidence, QMS, declaration of conformity, labelling and promotion – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.2.3-QMS: Establish and maintain, for every device class, a QMS with records suited to the processes and products, aligned with ISO 13485 and ISO 14971 at their latest editions

What does 6.2.2.3-QMS require?

Law should oblige manufacturers of all device classes to set up and keep a quality management system and its records, fitted to their own processes and products, so that devices are designed and made so that they stay safe, perform and keep their quality over their life and so that the technical evidence behind the declaration of conformity is gathered under control. The GMRF recommends aligning the QMS with ISO 13485:2016 and risk management with ISO 14971:2019, always applying the current editions, with sound record-keeping and retention. The extent of external audit depends on class: usually none before market entry for Class A (except sterile or measuring devices), while for Classes B to D the NRA should be assured that a suitable QMS is currently operating or audit it before authorization, often relying on certificates from recognised bodies.

Maintained by Gerard Blokdyk

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