How to Write an ISO or API Compliant Quality Manual

quality manual

How To Build A Perfect Quality Manual Quality Manual Series: Part 3 of 3 Ah, so you read my part 1, “The Abominable Quality Manual,” and part 2, “How Did We Get Here,” and now you are ready to learn how to build a perfect Quality Manual. Well, I have good news and bad news …

ISO: Most Frequently Asked Questions

Befuddlement

Have you ever been audited by an ISO auditor? If you have, then you should know that there are a set of questions that are frequently asked during audits against various ISO standards …

Excuse Me, Mr. Auditor, Can I Phone a Friend?

There you are, in the middle of an Internal or External Audit, and the Auditor asks you a question that you are truly not sure about. What do you do? Hit the panic button. Ask the audience for a hint. Phone a friend. Well, there isn’t a studio audience, and chances are the Auditor didn’t …

Hello Mr. Auditee: Did Mickey Mouse Help in Your Root Cause Analysis?

Ok, so you issued a nonconformity to your auditee or vendor and you are hoping that they will review the problem in such a manner that the current problem will be solved and similar problems will be prevented from happening again. You ask for a formal response and to your surprise, when you see the …

Hey, Mr. Auditor: This Is a Mickey Mouse Nonconformity. Show Me the Value!

Have you ever been audited and felt like the findings the auditor was bringing up were minutia and almost irrelevant in the context of the major challenges and goals setup in your organization? Did you almost feel like they were mickey-mouse or minutia issues compared to the big tidal waves your organization is going through. …

How to Pass an ISO Audit?

I’ve worked with several companies over the years and dealt with different individuals, different processes and different levels of ISO 9000 understanding. However when an organization is getting ready to apply for ISO 9000 certification, the question remains: “Are we going to pass the audit? Similar questions I have been asked are: How many of …

ISO Audit Results and Nonconformities

There are some misconceptions about what ISO audit findings are. In this article, I attempt to explain clearly what audit findings are, what types of findings may be generated in an audit and the guidelines that is widely use to categorize audit findings. What are the results of audits? Depending on the audit style adopted …

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The Essential Steps to Jumpstart your ISO/API Certification Journey!

These are the same steps our own Consultants use to successfully guide our clients to achieve ISO/API certification