ISO 13485-2016-Medical QMS

ISO 13485:2016 sets out the requirements for a quality management system covering the design, development, production, installation and servicing of medical devices and related services. It is used by device manufacturers, suppliers of components and materials, sterilisation providers and distributors, whatever their size or type, and every requirement bends towards one end: that devices consistently meet customer and applicable regulatory requirements, with patient safety and product effectiveness as the overriding emphasis.

Built on the ISO 9001 process approach, ISO 13485 presses harder on regulatory compliance, on risk management applied throughout product realisation, and on keeping processes documented. Its requirements run through management responsibility and a documented QMS; design and development controls and the medical device file; document and record control; risk management aligned with ISO 14971 principles; control of production and service provision, including cleanliness, contamination control and sterilisation where applicable; validation of processes and software; identification and traceability of devices; and complaints, adverse-event reporting, corrective and preventive action and post-market feedback. It sits beneath the frameworks that decide market access — the EU Medical Device Regulation, the FDA Quality System Regulation and the requirements underpinning the Medical Device Single Audit Program — and certification is granted by an accredited body after audit, then held through surveillance and recertification.