In November of 1998, I was invited to attend the chairholder’s council of NCCLS (now called CLSI). This is a meeting of the leaders of the committees that produce clinical laboratory standards. During the meeting, NCCLS started a quality initiative kicked off with a keynote speech and rationale for the program by David Nevalainen, listed at the time as from the Abbott Quality Institute (1). He presented a quality system quite similar to ISO 9000. I commented at the presentation that in my experience, ISO 9000 (upon which the NCCLS quality system is based) has had virtually no impact on quality in industry. (I believe this is still true). There was no reaction to my comment.
One year latter, I was attending the November 1999 chairholder’s council. In the lobby of the hotel, I was reading the Wall Street Journal when I noticed that one of the top stories was about an FDA fine for Abbott quality problems. The fine was for 100 million dollars and ordered Abbott to stop selling certain assays (2). When I tried to point out to NCCLS senior management the connection among the NCCLS quality system, Nevalainen, and Abbott, I got no reaction.
- See, for example: http://arpa.allenpress.com/arpaonline/?request=get-document&doi=10.1043%2F0003-9985(1999)123%3C0566:TQSA%3E2.0.CO%3B2
- Abbott to pay $100 million in fine to U.S. The Wall Street Journal, November 3, 1999.