Management system standards
Providing a model to follow when setting up and operating a management system, find out more about how MSS work and where they can be applied.
Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.
Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485.
Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.
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Reference number
ISO 13485:2016
ISO 13485:2016
© ISO 2024
International Standard
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
Edition 3
2016-03
2016-03
Medical devices — Quality management systems — Requirements for regulatory purposes
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Productos sanitarios: los básicos
Este paquete agrupa las normas ISO esenciales para brindar un marco sólido para la gestión de la calidad y la gestión de riesgos en la industria de productos sanitarios.
- ISO 13485:2016
- Guía práctica sobre ISO 13485:2016
- ISO 14971:2019
- ISO/TR 24971:2020
What you need to know about iso 13485
What is a medical device?
A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
Who is ISO 13485 for?
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Certification to ISO 13485
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.
Read more about certification to ISO’s management system standards.
Why was ISO 13485 revised and what are the main improvements?
All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
Handbook intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485.
A free brochure with tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.
Transitioning to ISO 13485:2016
Learn more about how to transition from ISO 13485:2003 to ISO 13485:2016 in this transition planning guidance document [PDF] developed by the technical committee.
