Category Archives: Auditing

Work Instructions and Audits

Question Regarding ISO 9001: 2008 (or 2015) auditing, I have always been trained that a work instruction when implemented as supporting the QMS can be audited as it is supporting the effectiveness of the QMS. I was recently told by … Continue reading

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Audit Timeline

Question What is the ASQ recommended time frame between an auditee receiving a final audit plan and the audit commencing at the auditee’s site? Answers From Charlie Cianfrani: ASQ does not have a recommendation! From George Hummel: This is not … Continue reading

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Internal Audits, Third Party Audit

Question Shouldn’t a company audit its own processes and procedures to ensure compliance before a third-party audit is scheduled? Answer Thanks for contacting ASQ’s Ask the Experts Program.  In response to your inquiry, yes, it would be a good idea … Continue reading

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Unsigned Audit Report

Question Is it acceptable for an auditor to submit an UNSIGNED audit report in Word version? I’m QA director at a pharmaceutical CRO. We were recently audited by one of our clients. They refuse to provide a signed audit report … Continue reading

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Audit Versus Inspection?

Question Would you please tell me what the differences between audit and inspection are? Answer This is a great question.   We can start with the definitions of inspection and audit per the new ISO 9000:2015 standard.  Inspection is “Determination of … Continue reading

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ISO 9001: 2015 Tools for Auditors and Risk Based Thinking

Question In addressing clause 4 of ISO 9001:2015 regarding organization context and interested parties, what type of tool (spreadsheet,diagram,flowchart,etc), would you recommend to use to simplify the practice and to give a proper  understanding for auditors ?  I understand that … Continue reading

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ISO 17025

Question 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) … Continue reading

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