ISO 17025 and Business Changes

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratoriesQuestion

My organization has just been recently accredited to ISO/IEC 17025:2005. Shortly thereafter, changes were made to the organization’s structure and business operations.  I would like to know:

1) When should these changes be reflected in the Quality Manual?

2) Do I need to advise the local registrar about the changes?

3) Are these changes time-sensitive that need to be reported to the certifying body to maintain certification or, should I just wait for the next surveillance audit coming in about six (6) months?

Answer

Thank you for your question.  Updates to your Quality Management System and Quality Manual should be made as soon as they are implemented.  I would suggest notifying your CB of the changes now and let them plan for auditing these changes.  They will likely want to roll that into your next surveillance and not make a special visit.  That decision, of course, would be up to them.

Denis

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

For more on this topic, please visit ASQ’s website.

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