August 2002

Vol. 4, No. 8

Implementing an effective quality system: 
George Hummel tells how

By George H. Hummel, CEO, IQC, Inc.

These steps, outlined by ISO expert and CEO George Hummel, will lead you through a successful implementation of an effective quality management system following requirements of ISO9000:2000 and related road maps.
Step 1: Understand the requirements for a Quality Management System (QMS)
Your organization will need a starting point and a decision about where you want to go. Your destination might  be 100% Customer Satisfaction, for example. Few can reach that goal without some guidance and direction, but there is a set of documents a road map, if you will available to us.  Those documents are ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000. 
Last issue, we discussed the Eight Quality Management Principles that are the foundation for an effective QMS. These are documented in ISO 9000:2000, Fundamentals and Vocabulary. Not only are these principles described, but also there is a wealth of information regarding the rationale for a QMS, the importance of the role of top management, the process approach and more!  There is also an excellent dictionary to help with the terms we will encounter along the way.  Before getting into the requirements of ISO 9001:2000, a review of this guideline is very helpful.
When you do read through ISO 9001:2000 yes, you do have to read it sometime! be aware of the concept of the process approach described in the Introduction section.  You will see this approach linked to Plan-Do-Check-Act (PDCA) throughout the standard. Your QMS and its processes can be built upon PDCA for maximum effectiveness.  If you are transitioning from ISO 9001/02:1994, Annex B provides a helpful key to the relationships between the old and new standards.
ISO 9004:2000 provides guidance on performance improvement beyond the minimum requirements for a QMS seen in ISO 9001:2000.  Many organizations did not see substantial improvement as a result of implementing the 1994 versions.  Here's why: once the standard had been implemented, the organization stood still. ISO 9001 requires continual improvement. ISO 9004:2000 can take you there.
The folks who wrote ISO 9001:2000 can help you, as well. Visit their Transition Planning Guide at
Step 2 Determine the Scope of your QMS
Since ISO 9001 was written for all sorts of organizations, some of it may not fit your organization.  You can exclude these non-relevant requirements if you follow the rules!  These are:  the exclusions can be only from clause 7; they do not affect your ability to provide your product; and the exclusion does affect your responsibility to meet a regulatory requirement.  To ensure that your exclusions are justifiable, you have to know the scope, or the boundaries of the system what it does or does not do.  Here, once again the writers of ISO 9001:2000 can help.  Go to
Step 3 Adopt the Process Approach
The definition of a process is 'a set of interrelated or interacting activities which transforms inputs into outputs. '  (ISO 9000:2000, 3.4.1)  In order to have an effective QMS, your organization must first identify your key processes the 50,000 foot view down at the organization that provides a view of the major activities that you perform to interact with your customers. These probably include processes such as marketing, sales, receiving orders, quality planning and the like. Our organization recommends creating a Master Process Flowchart.  Once these key processes are identified, you must ask if the process owner has been identified and given adequate resources, responsibility, and authority to execute the process in a manner that prevents problems, meets requirements, and increases customer satisfaction. The PDCA concept can be applied to these processes themselves:  PLAN --what are the quality objectives for the process; DO has the process been implemented effectively and its links with other processes defined; CHECK how is the process monitored and measured; and, ACT the steps taken to ensure continual improvement.
In the next issue, we'll describe steps 4 through 10.

Copyright 2002 PQ Systems.

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