In the attempt to create a fully
By contrast, procedural documentation and forms, whether effective or not, are more easily
In the case of manual design, it is necessary to
This issue of content existed for the 1987 and 1994 versions of the international Standard and has already shown to be the same for the 2000 version. In fact, there were ISO 9001:2000-paraphrased manual software advertisements on the market before the Standard's final draft was even released.
All of these topics are discussed in detail within this book and the reader is presented with a number of alternative approaches to the manual's content—all of which, we believe, are in full compliance with the Standard.
Our observations with regard to manual content are based on the review of over 100 manuals during 10
This wide interpretive disparity of the ISO 9000 guidelines—
We believe that a clear controversy exists with regard to what
This book asserts that it is through the flow of prescriptive, quality policy statements into the lower tier documentation—and the resultant operational feedback by users of that documentation to the organization's top management—that completeness, closure, and continuous QMS informational growth occurs.
As indicated in Figure 5.1, once the strategic plan is created and the
Figure 5.1: Typical ISO 9001—2000 certification gates.
We note that the manual is derived from an analysis of the organization's total processes—from its strategic front-end
Most importantly, to
Once the manual is complete, the process/procedural documents can be finalized and a total quality auditing system can be put in place to monitor the effective implementation of the QMS. By total quality auditing, we mean
In addition, the manual is the first document seen by the registrar's auditors when the time comes to schedule the initial (certification) assessment. Unless the manual is acceptable, the registrar normally can go no further into the process. The manual review (a central part of the document review process) is often accomplished by the registrar as either an off-site activity or part of a documentation review in your facility prior to either the on-site initial assessment or the optional on-site preassessment.
The manual is also the primary document
The manual is the major driver for effectiveness in the QMS because it
We have observed in practice that a fully compliant manual—that reflects both the personality and technical competence of the organization—significantly enhances the organization's competitive position. By comparison, we have observed that an inadequate manual has
In juxtaposition to the intrinsic value of a prescriptive manual, the following rationale is used by practitioners to answer why it doesn't matter if the manual is useless:
Disinterest on the part of the customer;
The only important documents are the operational ones;
Disinterest on the part of the distributor;
Protection of proprietary information;
Disinterest on the part of top management;
Wish to minimize the documentation effort;
Insensitivity to those who want to understand the enterprise's strategic market position;
Disinterest on the part of the employees;
Misunderstanding of the manual's value as the primary navigator to find documentation;
The position that the employees don't need to read the manual anyway;
The customer simply wants a summary manual.
Of course, there are elements of truth in each of these
Based on this discussion, we see that although the manual is of an intrinsic value to the organization because it describes the strategic organizational viewpoint, a lack of definitive criteria establishes what constitutes a fully responsive manual. This interpretive issue has always existed with the previous ISO 9000 versions, and we already see a worsening situation for ISO 9001:2000, which requires even more interpretive aid than the previous versions  . The tendency is to continue to trivialize the manual through a slightly revised restatement of the Standard's text. We have concluded that the controversy needs much attention.
We believe that the controversy is a result of rapid growth in the ISO 9000 industry. For example, approximately 10 years ago, in the very early days of United States entry into the world of ISO 9000, we found that the manual's structure was
Relatively few suppliers that were large,
The involvement of basically only high-tech organizations;
The involvement of a limited number of registrars;
Lead assessors shared similar quality-assurance backgrounds;
A strong TQM influence;
Basic quality programs
We observed that the manual controversy grew slowly after 1994, and then in the period 1995 to the present accelerated into what we believe is a major issue. We have concluded that this change is due in part to the following:
The explosion of candidates in small, medium, and large organizations in extremely diverse fields;
Candidates in widely ranging levels of technology;
A broad spectrum of lead assessors with varied backgrounds;
Enhancements to TQM—for example, reengineering, quality function deployment (QFD), six sigma programs, enhanced Statistical Process Control (SPC), best practices management; business process engineering;
The introduction of both integrated Standards—for example, QS-9000/ISO/TS 16949 (automotive), ISO 14000 (environmental), TL-9000 (telecommunications), AS9000 (aerospace), FDA/CGMPs (USA) medical devices, Medical Device Directive (International); and a
We offer our approach to ISO 9000 QMS design in an attempt to harmonize such widely disparate perspectives. We feel that our design rules form a common ground for discussion and agreement.
 See, for example, Kannan, V., et al., "Tools and Techniques of Quality Management: An Empirical Investigation of Their Impact on Performance," QMJ , Vol. 6, No. 3, 1999.
 See, for example, Russell, J. P., The Quality Audit Handbook, Second Edition , Milwaukee, WI: ASQ Quality Press, 2000.
 See, for example, "First Interpretations Stall Over Possible Lapse in Process," Quality Systems Update , Volume 11, Number 11, November 2001, at http://www.qsuonline.com.
 This observation is supported in part by data presented on p. 20 of Quality , (January 1997), which notes that, in general, larger companies have been registered longer than smaller companies.
 The Registered Company Directory, North America, 1999 , McGraw-Hill Companies, publisher of Quality Systems Update , Columbus, OH (e-mail: <firstname.lastname@example.org>) lists the profiles of 84 accredited registrars and four unaccredited registrars in North America.