ISO 13485 - Medical devices - A practical guide

Advice from ISO/TC 210

About this handbook

All organizations face challenges when developing or updating their quality management system (QMS) and it is hoped that this handbook will be used to provide additional insight and understanding of the requirements in ISO 13485 1), Medical devices – Quality management systems – Requirements for regulatory purposes. It is not expected that you will sit down and read this handbook in one sitting, but that you might use it as a reference when questions come up about specific requirements. Therefore, it is broken up into the sections outlined in the contents in line with the clause structure of ISO 13485.

It is expected that you have basic practical experience with QMS and the applicable regulatory requirements within the medical devices sector to effectively understand the guidance provided. In this handbook, advice to guide understanding of ISO 13485 and its application is given by first listing the full text of ISO 13485, followed by the intent of that section and relevant guidance. Examples have been used wherever possible as an aid to understanding what the requirements mean.

This handbook has been written by a task group of technical experts from ISO’s Technical Committee TC 210 and is intended to guide organizations that provide product, including services, that affect any part of the lifecycle or supply chain of a medical device.

Such organizations can be manufacturers, importers, distributors, service providers or authorized representatives. In addition, this handbook can be useful to regulatory authorities and certification bodies concerned with conformity to ISO 13485.

The guidance given in this handbook describes concepts and methods that can be considered by your organization to assist in the development, implementation and maintenance of your QMS and this can be applicable to the design, development, production, installation, servicing and post market surveillance of medical devices. This handbook has taken into consideration requirements and guidance contained in documents as listed in the bibliography from the following organizations:

• International Medical Device Regulators Forum (IMDRF) including those documents maintained from the disbanded Global Harmonization Task Force (GHTF);
• International Organization for Standardization (ISO);
• European Committees for Standardization (CEN and CENELEC);
• National regulatory bodies.