ISO has produced a Draft International Standard (DIS) version of ISO 7101 “Healthcare Quality Management Systems — Requirements.” The DIS is currently being circulated for feedback from the public and ISO member body representatives.

The standard aims to provide quality management system requirements specific for healthcare providers, including doctors, hospitals, hospices, and other related enterprises. The standard is produced by ISO Technical Committee 304.

The existence of the standard reveals that ISO has formally moved away from its prior mandates to “limit the proliferation of quality management systems,” which had been a formal directive issued to TC 176, the committee that authors the ISO 9001 standard. Now, not only has ISO fully embraced the notion of having competing quality management system standards, it has allowed other TCs entirely to produce them. ISO TC 176 no longer holds sole responsibility for QMS standards.

The risk, of course, is that ISO is cannibalizing its own product lines, but for now it appears ISO is willing to take that risk.

I have provided my official comments to both ANSI (USA) and INACAL (Peru), after a fairly exhaustive review. I won’t outline all of the issues with the standard, but here are a few highlighted problems with the current draft:

  1. Mixed adherence to Annex SL text causes confusion. They have adhered to the idea of “documented information” — which confuses documents from records. It’s not clear when records are actually required by the standard, and given that we are talking healthcare, this could literally increase patient risk.
  2. The standard drops ISO 9001’s PDCA model in favor of a PDSA model (Plan, Do, Study, Act.)
  3. The standard attempts to standardize impossible concepts such as “kindness,” “ethics,” “fairness,” and “justice.” Another clause requires that the user organization ensure they have “heard the people’s voice.” Once again, an ISO TC creates a standard intended for third-party certification without understanding how to write requirements that can be verified through objective evidence.
  4. The standard bizarrely puts the responsibility for the provision of “universal healthcare” on user organizations. The target for this standard is healthcare providers, not government policymakers, so this makes no sense at all. A hospital cannot unilaterally decide to provide “universal healthcare.”

As it’s written right now, the standard would be unlikely to receive enough votes to pass, given the political and social language that is included in the standard.

To comment on the DIS, you must submit your comments to your nation’s official ISO member body. You can find those here.

About Christopher Paris

Christopher Paris is the founder and VP Operations of Oxebridge. He has over 30 years' experience implementing ISO 9001 and AS9100 systems, and is a vocal advocate for the development and use of standards from the point of view of actual users. He is the author of Surviving ISO 9001 and Surviving AS9100. He reviews wines for the irreverent wine blog, Winepisser.


Traditional Tri-System