Shipped November 01, 2021


This paper challenge was sent to category A and C1 laboratories. The following scenario was presented to participants:

ISO 15189, the international foundation for medical laboratory quality and competence states, “The laboratory shall establish and implement an internal audit program that includes the selection of auditors who are trained to assess performance of the laboratory’s management system.”

Which of the following would be acceptable approaches for training auditors to perform laboratory internal audits.

A. invite staff to read ISO 15189 (or their provincial accreditation standard) prior to performing the internal audit

B. invite staff to view YouTube videos on Internal Audits-15189 prior to performing the                internal audit

C. develop an in-house seminar/discussion based auditor training program

D. have staff participate in an externally developed internal audit training program

E. all the above are correct.



  1. Internal Audits must be done by people who are trained to perform audits and deemed to be competent.
  2. Asking staff to read a standard or view a video in preparation to perform and internal audit  in the absence of informed auditor training creates a high risk for error and incomplete or inaccurate audits.

Full critique (PDF)

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