Next for ISO 13485

Paul Brooks, VP of Healthcare Solutions at BSI Group America, recently sent an ISO 13485 e-Update on the next steps for ISO 13485:2003.

Mr. Brooks explained that the International Standards Committee, ISO TC 210 Working Group 1, has the responsibility for the maintenance, review, and updating of ISO 13485:2003 Medical Devices — Quality Management Systems – Requirements for Regulatory Purposes. ISO rules require formal, five-year reviews of standards, but in the case of ISO 13485, it was deferred until 2011, given that the Transition Period for fully adopting the standard ended in 2006.

The ISO TC 210 Working Group 1 met in April 2011 at a joint meeting with Study Group 3 of the Global Harmonization Task Force (GHTF). At this meeting, they met, reviewed, and debated the next steps for ISO 13485. According to Mr. Brooks, after much consideration, it was decided to compile a New Work Item Proposal for review by ISO Member Bodies. It was also agreed to compile a User Survey in order to solicit feedback (positive and negative) from the users of the Standard. The responses will be analyzed to provide feedback into future discussions.

The survey will take approximately 30 minutes to complete and will remain open until August 31, 2011. Mr. Brooks said that BSI encourages all users within your organization to complete the survey, but in particular your Quality and Regulatory personnel. Click here for the ISO 13485 Revision User Requirements Survey.

The e-Update quoted Paul Sim, BSI, U.K. Country Delegation Leader to ISO TC 210, “I can assure you that all feedback will be considered, analyzed, and used as extremely valuable input into the next revision of ISO 13485, should that be the result of the New Work Item Proposal vote. Thank you for your time and support.” You can provide any comments or questions to Mr. Sim directly at