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ISO 13485 Accreditation

Accreditation for ISO 13485 -

Medical Device

Quality Management

 

 

About ISO 13485 and Accreditation

ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) for the design and manufacture of medical devices. The standard is designed to help organizations demonstrate their ability to provide medical devices that meet customer and regulatory requirements. UQAS is an internationally recognized accreditation body that grants accreditation to certification bodies who issue ISO 13485 certificates to medical device manufacturers. Accreditation aids in the mutual recognition of certificates and demonstrates the competence and impartiality of the certification body.

 

Requirements for ISO 13485 Accreditation

UQAS grants ISO 13485 accreditation to organizations with reference to the following standards:

  • ISO/IEC 17021-1:2016 - Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements

  • ISO/IEC 17011:2017 - Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies

  • IAF MD 8:2020 - Application of ISO/IEC 17011:2017 in the Field of Medical Device Quality Management Systems (ISO 13485) 

  • IAF MD 9:2022 - Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)

 

Reasons to Become an ISO 13485 Accredited Certification Body

There are numerous benefits to becoming an ISO 13485 accredited certification body, including:

  • Credibility - By becoming accredited, you will be seen as a credible source of ISO 13485 certificate. This can help you attract new clients and grow your business.

  • Mutual Recognition of Certificates - As an accredited certification body, your ISO 13485 certificates will be recognized by other accredited bodies around the world. This facilitates international trade and allows medical device manufacturers to access new markets.

  • Increased Competitiveness - In today’s global market, many customers require certification from an accredited body. By becoming accredited, you will be able to compete for this business.

  • Improved Quality - The accreditation process is designed to help certification bodies improve their quality management systems. As a result, you can expect to see improvements in the quality of your certificates.

 

Contact us Today!

If you are a certification body interested in becoming accredited for ISO 13485, we invite you to contact us today. We would be happy to discuss the accreditation process with you and answer any questions you may have.