What is a Quality Management System (QMS)?  It is a management system pure and simple.  It is not quality’s management system; it is a management system that, if done right, produces quality products.  Quality Management Systems are built for ISO registration, to satisfy customer requirements, or to produce better products.  Building a robust QMS is not hard if you follow these 10 easy steps.

1. Define and Map your processes.  The process of creating your process maps will force you to define your processes and the sequence and interaction of those processes.  Process maps are important for understanding who is responsible for what.  They define your core business process and communicate the flow of your business.  When mapping your processes:

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There are two types of actions in an ISO 9001 Quality Management System: Corrective action and preventive action.  Many people struggle with just what a preventive action looks like and how it differs from a corrective action.  What’s funny about this discussion is how everyone tries to explain the difference as merely an interpretation of the words “occurrence” and “potential”.

For example, the ISO 9000:2005 definition states:

Corrective Action (Clause 3.6.5):
action to eliminate the cause of a detected nonconformity and its recurrence.

Preventive Action (Clause 3.6.4):
action to eliminate the cause of a potential nonconformity and its occurrence.

But does this really clear it up for anyone?

What’s the Difference between Corrective Action and Preventive Action?

Corrective action is performed on detected nonconformities.  In other words, there are real defects that exist right now

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As the Quality Manager you are responsible for Quality Management System (QMS) compliance.  In other words, you must manage all company-wide, quality policies, procedures, processes, programs, and practices, to assure the company of continuous conformance with appropriate standards and regulations.  In a smaller company you may also be the document control manager, quality auditor, and process improvement specialist.

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Developing an ISO 9001 Quality Management System (QMS) requires a lot of effort to create a system, change employee behavior (management and workers), and obtain the desired results.  Many companies have successfully built an ISO QMS, passed their initial registration audit, and later failed to maintain all of the documents, records, and quality process activities.  Creating an ISO QMS is one thing but maintaining it can be just as difficult for your organization.

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PDCA (Plan, Do, Check, Act) Cycles refers to the PDCA wheel (Figure 1) and the continuous motion that PDCA requires.  PDCA is not as easy as it sounds but, if you are interested in ISO 9001 Quality Management Systems (QMS), then you will find that PDCA cycles are the foundation for all ISO 9001 cycles.  Master PDCA and you will become the master of your ISO 9001 QMS.

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What is the first thing you think of when you hear the term “ISO 9001“? Lengthy policies, complicated procedures, and miles of forms to fill out?  A bureaucracy that rivals the US government in size and complexity? Intense, week-long audits that make waterboarding seem like spa therapy? You may be misinformed — ISO 9001 is based on sound business practices and is designed to help your organization improve incrementally.

Now, what do you think of when you hear the term “lean“? Are you thinking “no fat”, as in Jack Sprat?  Do the words “efficient”, “effective”, or “no waste” come to mind?

If we put the two terms together, we get Lean ISO 9001, which means a quality management system (QMS) with no fat…an ISO 9001 system that is efficient, effective, and reduces waste within your organization. Who wouldn’t want that?

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Sounds easy in principle, doesn’t it? Just plan your work and work your plan. So, why is “plan-do-check-act” so difficult in practice? Using the Plan-Do-Check-Act (PDCA) method is like climbing a hill: it starts out easy but gets harder the higher up you go.

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Officially, the worst global economic recession in several generations ended over a year ago and we are on the way back, according to the U.S. National Bureau of Economic Research. Unofficially, they need to revisit their definition of “recession”, as most of us are still plagued by a tight money supply, a lethargic job market, stagnating production and a general crisis of confidence.

Some of you aren’t buying the “fear, uncertainty, and doubt“ story, though. You’re going about your business logically, methodically, and with a clear sense of direction and purpose. You’re making things happen now and you’ll be in the lead when 2011 rolls around.

For the rest of us, there are many things we could be doing to make great strides forward in the coming year. Among them are implementing or refining the following key procedures:

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In part 1 of this two-part series, we discussed three important reasons why quality management systems (QMS) projects fail. Here are four other reasons:

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Lean approach simplifies the ISO 9001:2008 quality procedures manual and clearly points out the required QMS procedures and records.

St. Louis, MO – June 18, 2009 – Bizmanualz, Inc., a business publications, training, and consulting company based in St. Louis, MO, today announced the release of the updated ISO 9001 Policies and Procedures Manual. The company has greatly improved its product by modeling its policies and procedures on the Deming (“Plan-Do-Check-Act”) Cycle.

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