Medical ISO 17021 Changes

The transition period for the new standard EN ISO/IEC 17021:2006 (Conformity assessment. Requirements for bodies providing audit and certification of management systems) ends on 15th September 2008.  This standard covers the requirements for certification bodies and the principles of management system certifications within an organisation, e.g.  ISO 9001 / ISO 13485 Quality and Regulatory Management Systems. 

As an accredited Certification Body we are required to follow this standard and implement these changes within our certification systems.  These changes affect some of your responsibilities, as well as the way that audits are conducted and reported, especially with respect to analysis and determination of corrective measures regarding non-conformities and observations.

Please click HERE [ PDF 1917 kB ] to download further information, which includes a letter from the TÜV Product Service Certification Panel with further information on the changes.  It is important that you take time to read this letter.

If you have any questions please contact info@tuvps.co.uk or call 01489558100