ISO 9001: 2000 Quality Management System Design

20.1 Proposal

Indeed, we live in a time of transition as we observe the quality of our quality practitioners inexorably decline into mediocrity ^[1]. The confusions of the 1994 revision have been magnified by the complexity and redundancy of the 2000 version. The practitioners who found it difficult to grasp the concept that quotes were an integral part of contract review, that statistical techniques applied to corrective and preventive action data analysis, and that returned goods (that belonged to the customer) were part of customer supplied product will find it even more difficult to grasp the 2000 version concepts of organizational process structures. I have already seen clients roll their eyes in disbelief when auditors cannot grasp their elegant solutions to flowed-down quality objectives. Additionally, paraphrased manuals remain common; hours of ISO 9001:2000 seminars result in clients who still have no idea about how to design their QMS; and debates on continuous versus continual improvement waste valuable training time.

The 2000 version changes are so significant that sector-specific-standards based on the Standard require global revisions to maintain harmony with the Standard. In addition, because of these significant changes, most 1994 certified organizations have seriously delayed their upgrade activity. This delay will most probably lead to a mad rush in 2003 to bring thousands of sites up to date by the mandatory December 15 of that year. Even at this late date, I have only upgraded 10 clients to ISO 9001:2000, and I complete about 70 third-party audits a year.

We have found that the following changes have caused the most confusion and most difficulty in implementation listed (in no particular order):

• The numbering system from 20 elements to 5 sections into which are integrated the old 20 elements;

• The requirement for a process-oriented QMS that has a major impact on the way top management must view the enterprise from a TQM perspective;

• The requirement of top management to continually improve the QMS effectiveness, especially its processes;

• The need to clearly define and document measurable quality objectives and to have those objectives flow down through the organization;

• The contradiction between the need for only six procedures and the requirement that documents are needed to ensure the effective planning, operation, and control of its processes, in conjunction with the note that procedures can be documented or not;

• Failure to clarify what a process document is and the definition that a procedure is a specified way to carry out an activity or a process;

• The broad-ranging title of 4.2.4: Control of Records, yet a narrow range of records defined in the Standard;

• The requirement to enhance customer satisfaction;

• The requirement that the management representative promote an awareness of customer requirements throughout the organization;

• The need for top management to assess opportunities for improvement and the need for QMS changes during management reviews;

• The need to evaluate the effectiveness of training;

• The requirements to maintain and manage organizational infrastructure and work environments;

• The stress on customer feedback and effective customer complaint resolution;

• The extensive use of quantitative methods to evaluate continual improvement;

• An annoying degree of redundancy.

We, of course, hope that our attempt to define an effective and affective set of QMS design rules will help in some measure to provide the tools needed to address this set of challenging requirements. Our stress has been on the over-all QMS design structure with multiple suggestions on how to create and optimize a QMS that directly conforms to the Standard's requirements. In particular, the use of quality policy statements in response to each SHALL will serve as a beacon to effectively highlight each of these requirements and lead to their resolution.

To successfully apply this structural beacon, we have demonstrated that the root causes of the observed QMS deficiencies in structure exist primarily in the tendency for authors to do the following:

• Lack clarity in their overall QMS structural design;

• Perform inadequate research into the reality of their system's performance;

• Place too little time in process-document creation;

• Place quality policy statements in lower level documents instead of in the chosen stand-alone manual;

• Paraphrase the Standard and leave out key prescriptive details for decision makers;

• Bypass SHALLS because of an incomplete analysis of the requirements;

• Use an integrated policy and procedure manual that does not fully respond to the Standard's requirements (SHALLS);

• Not stress the importance of tier-to-tier linkage;

• Maintain redundant procedures in several documentation tiers;

• Have no reliable source of interpretation to turn to.

This tendency is a result of an industry-wide disagreement by ISO 9000 practitioners on the purpose and structure of the manual. The result is confusion over what constitutes an effectively written document and what are the specific textual tools that we have to create the manual. Such practices are counterproductive because they invariably produce redundancy, omission, and noncompliance with the Standard.

To ameliorate this situation, we have attempted to place QMS documentation design and implementation on a scientific foundation. We have proposed a number of design rules that we believe produce compliant quality manuals—and, as a result, compliant quality management systems. Such systems integrate business strategy with quality management and thereby form the organization's total QMS strategic enterprise position.

Leadership is the ability to extend what is known while, concurrently, inspiring others to support you in your venture. Leadership is dynamic and self fulfilling. That is why you can achieve the same goals through widely different strategies. A dedicated group will meet their goals regardless of the leader's specific directives. A dedicated group will succeed even when the leader is less than adequate to the task. The leader cannot destroy the underlying professionalism of an individual. Many a leader has thought that they had been the motivator because the group succeeded, not realizing that the group succeeded in spite of its leader's incompetence.

As this unique human phenomenon is true in all human activity, it holds true in the creation of an effective QMS. Accordingly, our design rules may be used in any order that you see fit. More rules that are appropriate to your specific enterprise needs can be added. What is key, however, is that our design rules be used somewhere in the process as a foundation and context for the QMS. The rules will create self consistency and diminish redundancy as well as promulgate clarity and vigor throughout the entire creative process.

A summary of the design rules and specifics of such techniques is addressed in Chapter 21. In this chapter, we wish to examine the anticipated benefits of a QMS that uses the proposed design rules.

^[1]Unfortunately, justifiable complaints against the ISO 9000 schema can be found throughout ISO 9000 publications (e.g., "ISO Warns Third-Party Industry to Police Its Self," Environmental Management Report, QSU Publishing Company, December 2001, p. 10. A more biting indictment is by Fahrlander, H. W. (Hank), Jr., "Don't Blame ISO 9000 for Poor Quality," Quality Systems Update, QSU Publishing Company, December 2001, p. 13.