Implementing an effective quality
George Hummel tells how
By George H. Hummel, CEO, IQC, Inc. firstname.lastname@example.org
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 ø a road map, if you will ø 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 ø yes, you do have to read it
sometime! ø 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 http://www.iso.ch/iso/en/ISOOnline.frontpage
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 ø 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 ø
what it does or does not do. Here, once again the writers of ISO
9001:2000 can help. Go to http://www.iso.ch/iso/en/ISOOnline.frontpage
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 ø 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 ø has the process been implemented
effectively and its links with other processes defined; CHECK ø how is the
process monitored and measured; and, ACT ø the steps taken to ensure
In the next issue, we'll describe steps 4 through 10.