ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes, the internationally recognized medical device industry quality management systems (QMS) standard, has been under revision since 2010. The published standard was available on 25 February 2016.
The new revision ISO 13485:2016 will NOT align with the revised high level structure, Annex SL, used in ISO 9001:2015. For those medical device manufacturers who hold dual certification, you will need to be aware and start to consider and develop transition plans to allow for a smooth migration from previous versions of the standards to the two newly released versions.
Cross referencing material will be available within the standard which will correlate the clauses of ISO 9001:2008 to the clauses of ISO 9001:2015. As with previous versions of ISO 13485, the standard will also contain cross referencing tables, i.e. ISO 13485:2016 with ISO 9001:2015.
This 1 hour long webinar will discuss the considerations needed to transition to the new standards within your organization taking into account the now different structures.
Stewart Brain is the QMS Certification Lead at BSI Medical Devices and has worked in the BSI Medical Devices Notified Body for 15 years. He has overall responsibility for the management of BSI's UKAS accredited ISO 13485 quality system certification program. Prior to this he was the Global Head of Microbiology for 10 years where he had overall responsibility for the microbiology and sterilization assessment work carried out by BSI.
Linda Moon is an IVD Product Specialist in Healthcare at BSI. Her key roles are assessing clients to ISO13485, CMDCAS, IVD and MDD quality systems management and ISO9001 and delivering training courses: predominantly ISO13485, internal auditor and the IVD courses.