3 Responses

  1. Phillip Rouviere
    Phillip Rouviere at |

    A must read for all professional auditors.

  2. Devin M
    Devin M at |

    I work in the medical device manufacturing industry as a professional consultant. One of my responsibilities is conducting ISO 13485 compliance audits. Some of my clients still have current ISO 9001 certificates (in addition to ISO 13485 certs). Do you believe that an ISO 9001 cert may actually be needed in the cases of medical device manufacturers that have current ISO 13485 certificates?

  3. Kairi Gainsborough
    Kairi Gainsborough at |

    I didn’t realize that so many companies waited until the last minute to update to ISO 9001:2000. You make a good point when you urge companies not to do the same thing with the current standards. If they haven’t already started, your section on how to begin the transition process would be really helpful. I would think that most companies would want to be proactive about this kind of thing.


Leave a Reply