Category Archives: Auditing

Relocation Requires Audit?

Question One of my contract manufacturers who is ISO 9001: 2008 certified, submitted a Supplier Change Notice to relocate their factory to a new site/location. This will trigger many activities including re-qualification, etc. My question is, for their ISO 9001 … Continue reading

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Special Process NCRs During Audit

Question Recently one of our business units had an ISO 9001: 2008 audit and during the audit they received a couple NCRs on welding as a special process. One of the NCRs was “Some welders are not qualified prior to … Continue reading

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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 and Business Changes

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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Internal Audits

Question If 2nd or 3rd party performs full system audit on my QMS, can it be used as to satisfy requirement for Internal Audit of that year? Answer Thank you for sending your question to ASQ’s Ask The Experts program. … Continue reading

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