Auditing Statistical Methods for ISO9001


Smith, Gordon E.   (1992, ASQC)   Massey University, Palmerston North, New Zealand

Annual Quality Congress, Nashville TN    Vol. 46    No. 0
QICID: 9905    May 1992    pp. 849-854
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Article Abstract

Clause 4.20 in ISO9001 states: "Where appropriate, the supplier shall establish procedures for identifying adequate statistical techniques required for verifying the acceptability of process capability and product characteristics." How does one decide when such procedures are appropriate? What statistical techniques are adequate? What constitutes verification?

The author presents a seven-stage approach to answering these questions:

  1. selection of important characteristics,
  2. selection of measurement methods,
  3. selection of statistical techniques,
  4. recording and reporting results,
  5. establishing control methods,
  6. ongoing verification,
  7. building specific work instructions.
For each step, the author provides an audit checklist to determine whether the step has been performed adequately. The checklist is appropriate both to someone performing the verification process and to an auditor checking that process. It provides a common ground from which both sides can understand the requirements of the verification task.


Audit checklist,ISO 9000,Statistics,Verification

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