September 2, 2020
Mireaux is here to help

Have you lost your Quality Manager, Document Control person or do you lack resources to maintain your Management System? Do not despair Mireaux is here to help!

In the recent months, we have experienced unprecedented events, and many of Mireaux Management Solutions’ Clients have lost valuable resources essential to their business.
November 18, 2019
5 signs your company is in dire need of root cause analysis and corrective action training

5 Signs Your Company Is in Dire Need of Root Cause Analysis & Corrective Action Training (With a Bonus Item for API Holders!)

If you are wondering whether your organization could benefit from formal Root Cause Analysis (RCA) and Corrective Action training, read below to see if any of these issues are present in your day to day operations.
April 8, 2014
quality manual

How to Write an ISO or API Compliant 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 ...
December 7, 2013
ft parrot

How did the Quality Manual Come to be a Mirror of the Standard?

How did this all start? Quality Manual Series: Part 2 of 3 Way back when, we used to have a Quality Manual with the following elements: A picture of our process map (to satisfy the sequence and interaction of the processes) ...
March 4, 2013

ISO: Most Frequently Asked Questions

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 ...
June 21, 2012

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 ...
June 6, 2011

If You Want Guaranteed Success, Then You Need Informal Assessments: Audits on Steroids

Have you ever wondered why the last Internal Audit or External Audit uncovered so many issues even though you thought everything was great? Are most of your nonconformities or corrective actions pointed out by external parties? If the answer to any of these questions is yes then what you may need in order to pass ...
April 7, 2011

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 ...
March 25, 2011

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. ...
July 11, 2010

What’s the Difference? Series: Gap Analysis vs. Internal Audits vs. Pre-Assessment

If you have ever wondered what the difference was between an audit, an assessment or a gap analysis, then you might not be alone. When trying to figure out whether your company meets the requirement of a standard, such as ISO, API, Safety, etc.; chances are you are trying to decide which one of these ...
July 24, 2009

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 ...
July 17, 2009

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 ...