ISO 13485 DIS2 – Update timeline, impact and anticipated publication

The text for ISO 13485 DIS2 (Draft International Standard) – Medical Devices - Quality Management Systems – requirements for regulatory purposes has been released by ISO for public comment. The voting period will close on the 5th May 2015. All comments must be submitted to ISO prior to this date.

For organizations within the United Kingdom where BSI is the National Standards Body, the voting period will close on Thursday 12th March 2015, to allow compilation of comments prior to a review meeting scheduled for later in March. Other National Standards Bodies may have an alternate closure date for comments.

All National standards bodies, including BSI, will review the document and submit both their comments and vote by the 5th May deadline to ISO. It is anticipated these comments will be reviewed at the next planned meeting of ISOTC 210 WG1 (ISO Technical Committee working on the revision of the standard), scheduled for June 2015 in Denver. From this meeting it is expected  that a Final DIS (FDIS) will be compiled and issued with a 2 month voting period. The expected time line will give a final publication toward the very end of 2015.

Proposed Structure of Revised ISO 13485

The content of this revision continues to be structured around the requirements detailed in the Design Specification. This includes the format, which, will be based on ISO 9001:2008. There is no plan, as part of this current revision, to align with the High Level Structure contained in Annex SL as applied in the new ISO 9001:2015.

Therefore, this 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. As we progress to publication of the revised ISO 13485, BSI will provide further information, including webinars, on the considerations needed to transition.

It is anticipated that cross referencing material will be available 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

How do I review the DIS?

• BSI is the National Standards Body in the United Kingdom and the document can be viewed from the BSI website. Reminder: the closing date for comments to BSI for their National Committee is Thursday 12th March 2015. The standard can be purchased via the BSI Shop.
• Or From the ISO website
• Or please contact your relevant National Standards Body to obtain a copy of the DIS. Please use the official template to feedback comments.

How can BSI help?

Should you have any comments specifically relating to ISO DIS 13485 or any further questions please contact Paul Sim: UKISO13485@bsigroup.com

Yours faithfully,

Paul Sim

Chairman BSI Standards Committee – CH 210