ISO 14971 authors, expertise, and potential conflicts of interest

November 28, 2007

I have questioned the elevated status of ISO standards claimed by some. Often, people justify this status by asserting that ISO standards are prepared by a consensus of experts. This entry explores three topics related to this assertion:

·        ISO authorship

·        Expertise of authors

·        Potential conflicts of interest for authors

The membership of an ISO committee

If you have an ISO document – I have the latest version of ISO 14971 – one thing to notice is that there is no list of authors nor even a list of the committee members. I don’t understand why it is the policy of ISO to hide this information, nor could I find such an explanation (or list of members).

Note that CLSI (formerly NCCLS) has in each standard a list of authors and subcommittee members, advisors, and observers (as well as area committee members).

What does it take to be an expert?

A simple if not flip answer to this is to be on an ISO committee, since by assertion, all committee members are experts. Of course, for ISO committees, one cannot form an opinion, since membership is unknown outside of the committee.

Potential conflicts of interest

Here are some opinions about conflict of interest regarding ISO membership (given that I don’t have a clue who the authors are). To understand conflict of interest concerns, it is helpful to understand that ISO documents have quasi regulatory status. As such, organizations can be divided into two groups: regulatory providers, and regulatory consumers (see post).

Manufacturers – The membership from this (regulatory consumer) group is often filled with regulatory affairs professionals. Their potential conflict of interest is to shape the documents to favor ease of compliance. They favor horizontal over vertical documents (see post).

Clinical laboratory or hospital professionals – Although this group would not seem to have a vested interest, one can question, how many of these people serve as consultants for industry. If a standard is written for the clinical laboratory or elsewhere in the hospital than this group has the same regulatory consumer potential conflict of interest as the manufacturer.

Regulators – As a regulatory provider group, the potential conflict of interest is the healthcare economics policy in place by the current administration.

Consultants – This group often has a high potential conflict of interest since some consultants make their living by helping companies comply with ISO standards.

Trade associations – This group is the voice of manufacturers and if represented on a ISO group has the same potential conflict of interest as for manufacturers, but with the added concern that trade groups are skilled in organizing manufacturers.

Note that for CLSI, any prospective member must fill out a conflict of interest statement. I am unaware of anyone ever being turned away from membership due to the conflict of interest statements.