Understanding ISO 13485

No one wants to be responsible for someone being hurt. Problems with medical devices can hurt people. So 13485 is written to make sure you follow the proven path all the time. They took the references to continuous improvement out of the ISO 9001:2000 document because improvement means change!

The FDA has articulated this issue from a very conservative point of view. It may be from reading their comments that they did not fully understand what the ISO language says.

For example, their first bullet about customer satisfaction. In my book, the safety and efficacy of a medical device has a whole lot to do with my satisfaction as a patient, or the medical parishioners' satisfaction in using it. Each of their points could be argued in similar manners. However, here are their words.

"FDA and medical device regulators from other countries see problems with enforcing some ISO 9001:2000 requirements relating to:

Assuring customer satisfaction: This goes beyond the safety and efficacy of medical devices. Therefore, to a large extent the requirement to assure customer satisfaction outside the purview of medical device regulators.

Engaging in continuous improvement (in regard to increasing efficiency): Improvement is within the medical device regulator's purview when it is done to correct violations. However, improvement for the sake of operating more efficiently is outside the purview of medical device regulatory agencies.

Documentation: ISO 9001: 2000 requires less documentation. Auditors and investigator, whether they be from FDA or from some other organization, need documentation to know what a company intends to do and what they actually did.

20 Element structure: The committee revising ISO 13485 intends to address these issues in their revisions. Also, ISO 9001:2000 is written using a process model approach instead of the twenty (20) element format used in ISO 9001:1987 and 1994. In a voluntary standards arena there is no requirement for a manufacturer to change the structure of its documentation to meet the format of the standard. In a regulatory environment, however, manufacturers often feel the need to align their documentation structure with that of the regulations.

Process Model: FDA sees no safety or quality benefit in having the manufacturers completely change their documentation structure and systems to the process model. Manufacturers may choose whatever documentation structure and system works best for their organization and regulatory obligations. The reasons the authors of the new ISO 9001:2000 changed to a process model are not necessarily transferable to the medical device industry.
It is interesting to note that the EPA has the same problem with ISO 14001, despite hard evidence that it works. They need the "command and control" model to feel comfortable. We all see (breath and drink) how well that has worked.

So when looking at the medical device additions (and deletions) from ISO 9001:2000 keep in mind the single-minded focus on safety and efficacy, with a pretty bureaucratic conservative approach.