New versions of ISO 13485 and ISO 9001, what do you need to consider?
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.