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Proposed Lapse Of ISO 9001:2008 Certification

Issuing time:2017-12-08 23:26

Following the recent updates to ISO 9001 and ISO 13485, DTR Medical have made the decision to no longer maintain certification to ISO 9001 as the standards have now diverged in format. ISO 9001:2015 now follows the Annex SL format, whilst ISO 13485:2016 has maintained the ISO Guide 83 format. This presents specific challenges to maintain certification to both standards whilst keeping costs at a minimum as there is a need for additional audit time as part of this divergence.

This change will not impact on the service or quality of products supplied by DTR Medical. ISO 9001 is a general management system which can be achieved by any industry regardless of whether it is medical based or not, while ISO 13485 provides requirements for a specific management system for the medical industry which is our focus. By concentrating on meeting and exceeding the requirements of ISO 13485, DTR Medical will strengthen their medical focus and be able to streamline internal processes in order to provide exceptional innovation, service and quality to our customers.

We do not anticipate any negative impact on our customers by no longer holding certification to this standard however, if you have any specific concerns please do not hesitate to contact us on

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