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ISO 13485 AND ISO 9001, with both changing are you prepared?

The 3rd revision of ISO 13485 will not align with the revised structure of ISO 9001:2015 when published. 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 current versions of the standards to the next. This webinar will discuss the considerations needed to transition to the new standards.

It is anticipated that cross referencing material will be available within the standards 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 13485:201X with ISO 9001:2008.

The webinar will help you to start planning for the changes you will need to make for the revisions.


Paul Sim

Joining BSI in August 2010 leading the BSI effort working with the Saudi Food & Drug Authority on the implementation of the SFDA Medical Device Interim Regulations. Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical, Ohmeda (formerly The BOC Group healthcare business)

Bill Enos

Bill Enos is the Microbiology Team Leader, Americas for BSI Medical Devices and has been with BSI for more than 10 years. His responsibilities include auditing quality systems and review of technical files and other certification activities related to sterile medical devices.