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FAQ

41.1 Question on Management Review clause 8.9.3 b)

By auditor standpoint, what is it expected to find in practices in a laboratory fulfilling the clause 8.9.3 b)? “The outputs from the Management Review shall record all decisions and actions related to at least: ..b) Improvement of laboratory activities related to the fulfilment of the requirements of this document.”

Records shall give evidence that the laboratory’s management has pursued the achievement of the improvement of laboratory activities already established in the management review, with respect to the ISO/IEC 17025 requirements.

As an example, the management review has certain inputs required, if we take internal audit, the management will discuss the implementation of the programme and concerns raised overall, trend analysis etc. This may well lead to the management team implementing changes to laboratory activities to improve the performance and compliance with external and internal requirements, this will need to be recorded as an output and this would address the clause as detailed in 8.9.3(b).

It is also important to state that there may well be no output from the management system review related to improving laboratory activities, this fully depends on the status of the system at the time. You have to balance the inputs with regards to the expected outputs.