QUESTION:

Fayyaz asks the following about APIQ1 :
Dear Sir
Kindly let me know that is there any INTERNATIONAL STANDARD or guideline for conducting API Q1 management reviews effectively on standard forms, records or patterns.

REPLY:

Hello Fayyaz,

There is no international standard or required format reporting or documenting management reviews.  Each organization must make their own decision as to the format that will work best for them.

As long as all input items as defined in clause 5.6.2 are presented or discussed and that the output items as defined in clause 5.6.3 are document, that all that’s required to show evidence of conformance.

A best practice is to prepare an agenda that shows all management review input items discussed as well as review of the quality policy and objectives.  The output items, which include action items or management decisions made regarding resources must be documented.

If a meeting is used to conduct the management review, consider documenting all information in the form of meeting minutes, along with names of all meeting attendees.

I hope this helps.

Best regards,

Bill Aston

Managing Director, ATCS