Following an extensive audit by the United Kingdom Accreditation Service (UKAS), LRQA has been granted accreditation to ISO 13485:2016, the international quality management system (QMS) standard for organizations involved in medical device manufacturing.
Published in March 2016, ISO 13485:2016 shares the same QMS principles of the previous version of the standard, but has not adopted the Annex SL high level structure reflected within ISO 9001:2015.
Holders of UKAS accredited certificates issued against either ISO 13485:2003 or the associated European Standard EN ISO 13485:2012 will have until March 31, 2019 to transition to the revised standard, after which the certificates will cease to be valid. New clients who wish to apply for certification to either of the aforementioned standards are strongly encouraged to apply for ISO 13485:2016 certification.
John Howlett, LRQA Technical Manager, Medical Devices, said, “The new ISO 13485:2016 standard presents organizations with an opportunity to make their management systems even more robust while aligning with the ever demanding global regulatory environment. Adopting the risk based approach and implementing the improved feedback processes should allow organizations to move beyond compliance to enhanced performance. Certified organizations should be acting now, as delaying transition and not planning ahead could potentially put your certificate at risk.”
With all the major ISO standards being revised, LRQA is at the forefront of communicating the changes. We offer a range of assessment services as well public and in-house training courses, all aimed at helping to ensure that organizations worldwide have a smooth transition to the new standards.
Contact us to learn more about ISO 13485:2016 UKAS accreditation