ISO 13485 Revision Update Status

The anticipated 2015 revision of  ISO 13485 did not receive the required votes to pass to the final draft stage. The working group is now tasked with resetting the process and developing a revised document to meet a proposed 2016 revision target.

Though this is a setback, we can look forward to ISO 9001and 14001 revisions later this year with ISO 13485 now targeted for a 2016 release. However, we do believe that a majority of the proposed major changes from the rejected FDIS will remain in effective in future revisions, plus hopefully alignment with the 9001:2015 requirements under guidance of Annex SL to simplify organizations QMS requirements.

ISO 13485 remains one of the strongest and fastest growing standards even in its older revision; many finished device manufactures are now mandating ISO 13485 registrations as a pre-contract requirement. This is leading to many lower tier suppliers seeking registration to ensure that they are ready to meet the growing medical devices market place, before seeking new customers.

NQA is one of the foremost registrars for 13485 certifications. Our medical device programs are supported by industry leading auditors, who understand an organizations’ needs and come with real hands on experience. Many have held the role as Quality Managers and Plant Managers of medical device manufactures themselves.

We do not provide notified body services or burden our organizations with additional visits, program days or charge travel time and reporting. We do provide value added, customer focused services with single point of contact for all customer needs with dedicated customer service personnel trained to understand the medical device industry’s needs.