Will ISO 13485 remain useful for its regulatory use purpose?

Will ISO 13485 remain useful for its regulatory use purpose?

ISO 13485 has been designated by ISO as a management system standard (MSS), more in particular a sector-specific MSS. The fact that ISO 13485 has been designated an MSS means, in principle, that if the standard is revised, it will have to adopt the high-level structure (HLS). This structure is known since 2012 as the ISO-HLS and is included in the ISO/IEC Directives as Annex SL (in the ISO supplement). Besides being mandatory for MSSs, it is more than just a structure for management system standards: it comes with some 10 pages of mandatory text. By the end of 2018, IEC decided to also adopt this HLS for standards within the IEC domain that also are (or can be considered) management system standards. With the publication of the 2019 edition of Part 1 of the ISO/IEC Directives, it is now available as Annex L.

The current (2016) edition of ISO 13485 does not comply with the ISO HLS. The standard did not have to comply either as the revision process was started before the HLS was declared mandatory. Also, regulators considered the mandatory language from the ISO HLS not acceptable for ISO 13485, with the “intended purpose” of the latter being for use in regulatory context. However, for any following revision of the standard, that timing argument will no longer work. The serious concerns by regulators, however, remain. There is no immediate concern but if a revision of ISO 13485 becomes necessary, the mandatory implementation of the ISO HLS is still there.

So, we have a few options to proceed: 1) avoid revision of ISO 13485; 2) modify the HLS so that it is no longer unacceptable to regulators; 3) have ISO 13485 removed from the list of MSS for which HLS is mandatory; and 4) forget about ISO altogether.

  1. This is our short-term approach. As long as we do not revise ISO 13485, there is no obligation to transform it to an HLS compatible standard;
  2. This is our second line approach. In 2018, following an enquiry about the HLS, it was concluded that a revision of the HLS would be appropriate. Clearly, different group will have different interests when it comes to revision of the HLS. Our interest is to have the regulatory obstacles removed;
  3. This is considered as a possible back-up plan in case the approach under 2) won’t provide sufficient change in the HLS such that regulators can accept it;
  4. This approach is currently not pursued but leaving ISO could be the ultimate scenario.

From ISO/TC 210, two people participate in the group discussing the HLS for the approach mentioned under 2): Melissa Torres (US FDA) and Scott Sardeson, WG1 convener. They had the first meeting of the group, Task Force TF14 of ISO/JTCG, late last February in Atlanta, GA. The Atlanta meeting was mainly an extensive group discussion, aimed to arrive at a common position. The next meeting of TF14 is scheduled for July 2019, in Vienna. Since that common position wasn’t really achieved at the Atlanta meeting, it is expected that part of the discussion will continue.  


At the Seoul meeting, November 2018, next to appointing the two representatives for ISO/TC 210, Melissa and Scott, also an ad hoc support group was set up. This group acts like a sounding board for the matter.