ISO 13485: Medical Devices Quality Management Systems – Requirements for Regulatory Purposes

What Is Accreditation for ISO 13485 Medical Devices Quality Management Systems?

ISO 13485 specifies requirements for a quality management system for the design and development, production, installation, and servicing of medical devices, and the design, development, and provision of related services. The international standard details management responsibility and applies to organizations involved with one or more stages of the medical device life cycle. It can also be used to assess the organization’s ability to meet customer and regulatory requirements in the medical device industry. The quality management system requirements specified in ISO 13485 are complementary to technical requirements for products.

CBs applying for ISO 13485 accreditation must conform to ISO/IEC 17021-1. ISO 13485 is a base standard program in ANAB’s fee schedule.

Please refer to the information about the accreditation process at How to Prepare for ANAB ISO/IEC 17021-1 Management Systems Accreditation.

You can view the ISO 13485 application to understand specific requirements but the application process must be completed via ANAB’s online application process.

Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices. Consequently, ISO 13485 expects that the organization:

• identifies its role(s) under applicable regulatory requirements;
• identifies the regulatory requirements that apply to its activities under these roles;
• incorporates these applicable regulatory requirements within its quality management system.

The definitions in applicable regulatory requirements differ from nation to nation and region to region. The organization needs to understand how the definitions in ISO 13485 will be interpreted in light of regulatory definitions in the jurisdictions in which the medical devices are made available.

This International Standard is used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements applicable to the quality management system and the organization’s own requirements.