Title
Medical devices - quality management systems - requirements for regulatory purposes.
Executive summary
Quality management systems for regulatory requirements for medical devices.
Abstract
This International Standards specifies requirements for a quality management system where an organization need to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. It is based on a process approach to quality management.
The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
This standard can be used by organizations for design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
This edition of ISO 13485 has a revised title and addresses quality assurance of product, customer requirements, and other elements of quality system management. It follows the format of ISO 9001 for the convenience of users in the medical device community.
Type
Specification
History and related standards:
This standard supersedes BS EN 13485:2001 and BS EN ISO 13488:2001 which are withdrawn. This is a stand-alone standard, which is based on ISO 9001. ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO 13485.
