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.

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ISO 13485:2016

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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?

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 latest quality management system practices, including changes in technology and regulatory requirements and expectations.

What are the key improvements?

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.

How can I purchase ISO 13485:2016?

ISO 13485:2016 is available from your national ISO member or the ISO Store.

ISO 13485:2016 - Medical devices - A practical guide
Handbook intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485.
ISO 13485 - Quality management for medical devices
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.

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