ISO 9001

August 10, 2012

Our ISO Management Rep is Leaving the Company: Should I Call 911?

Your ISO management Rep is leaving the company, and you have yet to reassign the post. Don’t worry – there is no need to hit the panic button or call 911. If you are wondering whether there are any formalities that need to be followed, then you are on the right track. With some simple ...
July 25, 2012

Document Review: Do I HAVE to?

Deciding how to control your documents can be difficult. ISO 9001 requires you to maintain accurate and up-to-date procedures, but doesn’t give a lot of guidance on how to get there. Between the requirements and the implementation lie grey areas and confusion. Let’s take a look at the difference between what is required and what ...
June 18, 2012

What’s the Difference Series: NCRs vs NCNs vs CARs vs PARs vs SCARs vs CAPA vs CPARs vs CIP

So, you think you’ve got it all figured it out, and then, BAM! Somebody else comes with a new acronym to throw you off your game. Well, don’t give up so soon. Quality is not that hard, or at least not as hard as some people expect it to be. It all boils down to ...
May 28, 2010

We are Just a Service Company, Why Do They Need Us to be ISO 9001 Certified?

Are you a service provider selling project management services, engineering or IT services? Have you been asked more than once whether you are ISO 9001 certified and wonder what is all that about? Before you tell your prospective client they have an error on their forms, see why more and more organizations are demanding their ...
April 16, 2010

Combining ISO 9001 with C-TPAT Requirements: A Simple Approach to Building an Integrated Quality Management System

Sweet Challenge I was called to a prospective client to help them implement ISO 9001. They seemed very interested at improving their processes in order to increase their quality and revenues. After contract negotiations, we were given the green light and quickly began process mapping the company’s main functions. As we moved from process mapping ...
February 19, 2010

Do You Feel Like Your Company is Acting Like a Chicken Without a Head? Find Out What Good Process Mapping Can Do for You!

What is Process Mapping Process mapping is an essential technique for identifying all the processes that take place in an organization as well as their interrelation so that it is easy to understand the sequence at which these processes take place. A good process map should be a high level map of how your organization ...
January 22, 2010

What’s the Difference? Series: Goals vs. Targets vs. Objectives vs. KPI’s vs. Metrics

A Game of Words As an auditor I always ask employees to tell me whether they are familiar with the company Quality Objectives or not. Obviously I may not ask that as a straight question but rather something like this: How do you know if you are doing a good job? Has your company established ...
December 11, 2009

Are You Sure Your Torque Wrench is Capable of the Force You are Using It For? How to Determine Effectively the Equipment Needed for Your Monitoring and Measurement Activities

In case you are not sure if the equipment you are currently using for your monitoring and measuring activities is the most adequate equipment or if you are wondering why such as expensive tool is used to inspect a certain part, then it may be worth for you to understand tolerances, accuracy and what the ...
October 30, 2009

ISO and Other Quality Initiatives Can Improve Our Processes, But Can They Improve Our Sales?

When a quality management system is implemented, results are evident immediately: reduction in warranty cost, reduction in rework, reduction in scrap, higher profit margins, etc. Would you agree that ISO and other quality initiatives such as Lean, Six Sigma, 5S can significantly improve any company’s processes -if requirements are correctly implemented? Why, if you know ...
September 18, 2009

The History Behind MXI-CON-HOU-SOP-2-009-A

Back when the ISO 9001 standard came about over 20 years ago, emphasis was on documentation and unfortunately not much on the organization’s processes. Although the standard was well intended it caused many companies to produce a chart similar to the one below: Most organizations had the exact same chart on their manuals and whether ...
August 28, 2009

Was is Necessary to Revise ISO 9001:2000 to ISO 9001:2008?

Since the inception of the ISO 9001:2000 revision it was clear that this version of the standard was so robust and coherent that more people were able to understand its tremendous value and potential for improving a company’s overall processes rather than being a mere documentation guide. In fact the standard was so well written ...
August 21, 2009

How to Handle Out-Of-Calibration Equipment Appropriately

If you have ever found equipment that is out of calibration, then you know it is not something to take lightly. Whether you manufacture children’s toys or automobile tires, you know that the implications and ramifications of the decisions you make, can be devastating for your company. Although the requirements from the ISO 9001 standard ...
August 7, 2009

Twenty Two Years After the Standard’s Inception, Why are There Companies Still Not ISO 9001 Certified?

Even after many years of hearing the word ISO 9000 and seeing many organizations get ISO certified, there are still companies who are skeptical when it comes to registering for ISO 9001 certification. For some, a misconception on the objectives of the ISO 9001 standard or the lack of knowledge may steer them off this ...
July 31, 2009

Do You Need a Consultant to Achieve ISO 9001 Certification?

Well, a simple answer is no, you don’t need a consultant to achieve ISO 9001 certification. In fact many companies achieve ISO 9001 on their own, by appointing key employees to the task. The implications however of trying to implement a system on your own can be a set back to your business if resources ...
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 ...
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