ISO 9001: 2000 Quality Management System Design

The 20th century will be remembered as the Century of Productivity, whereas the 21st century will come to be known as the Century of Quality. So predicts Dr. Joseph M. Juran, father of the quality movement.

—Joseph A. DeFeo, "The Future Impact of Quality" Quality Engineering, Marcel Dekker, Volume 13, Number 3, 2001

Why We Are Replacing 13 Million Firestone Tires: Ford Motor Company is replacing all Firestone Wilderness AT tires on any Ford Motor Company vehicle. This action is a precautionary measure. Our analysis of real-world data, information from the federal government and lab testing indicate that some of the Firestone Wilderness AT tires not covered by last year's recall could, at some time in the future, experience increased failure rates.

— Ford Motor Company Advertisement, Friday, May 24, 2001, The Boston Globe, p. A27

Quality in a World of Globalization Without question, product quality is needed now as never before. Poor quality, especially in a world of globalization, equates to costs of nonconformance in the area of billions of dollars and, most importantly, oftentimes costs human life.

The pursuit of product quality requires that an organization create a quality framework. The ISO 9001:2000 quality management system (QMS) is an internationally established quality framework. This book is designed to assist an organization to structure an ISO 9001:2000 QMS on some well-established documentation and implementation concepts that have been proven to be effective based on ten years of intensive consulting and auditing experiences with 106 ISO 9000-certified organizations. The intent of this exercise is to provide the reader with a reasonable probability of maximized organizational productivity when the ISO 9001:2000 system is implemented.

The book's objective is to establish an engineering design approach to create a compliant ISO 9001:2000 QMS. Our design rules are constructed to effectively minimize documentation in a way that still increases implementation usage and fosters a dynamic demonstration of continual improvement.

An effectively designed QMS should do the following:

The book's approach is based primarily upon an interpretation of the requirements stated in the Standard and its associated guidelines. The directives are encased within the context of 39 years of experience in the management of high-tech research, engineering, marketing and sales, quality, manufacturing, and service organizations.

Although the design rules are generic, the text covers 1994–2000 upgrades in detail (the cut-and-paste and fill-in techniques) because over 400,000 1994-certified sites require upgrades prior to December 15, 2003. As a result, the upgrade requirement was used as the basis for the first case study. The second case study is designed for someone who needs to create a QMS from the ground floor using the book's design rules. The second case study is much shorter, as the first case study ends up with a complete quality manual that, in tone and structure, is similar to a first created quality manual.

Origins The ISO 9000 schema has matured to the point that it contains its own scholarship, mythology, and sibling conflicts. The program has transitioned to one of big business, complete with a plethora of international accreditation boards, registrars, trainers, and consultants under contract to thousands of global organizations. We have termed this group of entrepreneurs the ISO 9000 practitioners [1].

Every week, the ISO schema becomes more entrenched into the fabric of business and society (e.g., the certification of Nasdaq's computer and network operations, facilities and technical services to ISO 9001; the development of FS 9000 for the financial sector; and the United States Army's planned adoption of ISO 14001 by 2005 [2]).

The ISO 9000 practitioners work within an exciting and dynamic environment that now fosters a myriad pattern of standards and interpretations of those standards. It is this book's intention to make a significant contribution to the clarification of this broad range of perspectives—both for those who wish to create an effective QMS and for those who audit those systems.

It is my privilege, as an independent subcontractor, to work with this group of remarkable talents on both sides of the ISO 9000 street. This situation has afforded me the opportunity to serve as a consultant and both assessor and auditee within the ISO 9000 certification process. Hopefully, this has also provided me a more balanced view in my role as provocateur. My ISO 9000 experience with over 100 organizations has been extremely positive, and it is my wish to share this unique opportunity with the entire ISO 9000 community.

It is this book's contention that a successful implementation of ISO 9001:2000 in any type of organization is the result of a fully compliant and strategically driven QMS. The design platform described in the book consists of a set of design tools that can create a fully compliant QMS whose fabric is an organization's strategic business declaration.

In most cases, ISO 9000 QMSs are difficult to document, implement, and maintain. The greatest difficulty lies in the demonstration of continual improvement. The lessons learned during my experiences with over 100 systems should not be lost but should be documented for others to evaluate and utilize to create their own effective ISO 9000 QMS. The effort required to create a QMS that conforms to the 2000 revision is no less and perhaps a bit greater than a QMS that conformed to the 1994 version. However, the versions are decidedly different in structure and tone. We hope that this book will clarify the differences for the certified-experienced readers and establish a clear structural context for those readers in the midst of their first certification.

This book will prove useful to those organizations that have already created a QMS but would like to bring their efforts to a new level of effectiveness.

The single most difficult aspect in the creation of an effective QMS is the need to create documentation that addresses a broad audience. It is also the most difficult aspect of this design approach, and we have worked diligently to illustrate how a QMS can be designed to provide the required information for all system users.

Although the book has been written at a technical level designed to reveal the operational beauty and power of the Standard, the conceptual nature of the Standard is not easily envisioned because of its hierarchal nature and descriptive style. We have worked very diligently to clarify and to offer alternative ways to address such issues.

Specifically, the text has been written for a diverse audience comprising the following:

Part Content This book establishes a set of design rules for effective QMS creation. In particular, the need for full compliance to each requirement (written as SHALL) of the Standard is addressed in detail. For completeness, several other system design configurations and strategies are also addressed, though in less detail. The overall structure of the book follows a hierarchal flow that first considers the total QMS design issue and then deals separately with the design of the quality manual, standard operating processes and procedures, work instructions, forms, and records, as well as a number of important supplemental design topics.

Part I establishes the basis for QMS design. It is imperative that the QMS be transparent to the overall strategic goals and objectives of the organization. To formalize this concept, this section deals with several possible choices upon which to base an integrated strategic and quality-based QMS design. The ISO 9001:2000 International Standard is chosen for further exposition because of its inherent international and national certification advantage. The fundamentals of ISO 9001:2000 QMS design are then discussed in detail (e.g., the three pillars of documentation, implementation, and demonstration of effectiveness that support QMS operational integrity; the QMS process model; continual/continuous improvement cycles; and mandatory documentation requirements).

Part II deals with QMS documentation design and establishes a four-tier documentation hierarchy as the basis for an effectively documented QMS. The critical role of the quality manual as a key driver to overall QMS effectiveness is discussed in detail. Then, the lower tier documentation (i.e., processes, procedures, forms, records, and other mandatory documents) is addressed in terms of optimum documentation structure and their specific roles in the QMS hierarchy.

Part III deals with QMS implementation and discusses organizational issues in regard to leadership, QMS planning, documentation implementation, and the impact of carefully planned internal audits.

Part IV describes the key change in philosophy from the previous ISO 9001 version, (i.e., the organization must now continually improve QMS effectiveness and accomplish this task via quantitative analysis of QMS performance). The critical area of quality objective design is then discussed in some detail in regard to formulation, implementation, and analysis.

Part V discusses QMS styles. The topics of inherent, broad readership requirements; the negative impact of a paraphrased manual; publication media choices, and effective writing styles are addressed to illustrate their impact on QMS effectiveness.

Part VI blends all of the tools together and summarizes their use in the creation of a fully compliant and strategically business-oriented QMS. This set of tools is deployed in the two case studies described in Part VII.

Part VII addresses the fact that there are over 400,000 1994 manuals that will need to be upgraded to the new Standard. Many thousands more will need to create their first manual in conformance with the Standard. As a result, we have created two case studies:

The first case study describes the upgrade and recertification of the Growth Corporation from ISO 9001:1994 to ISO 9001:2000. The exercise is based on a wholly fictitious (although you may spot yourself) but completely formed high-tech organization that utilizes this book's set of design tools. The corporation chooses a cut-and-paste and fill-in approach to electronically cut up the old manual:1994 into the new manual:2000. The result is a stand-alone form of quality manual in which the sections directly form a complete and compliant manual:2000 contained within this book. [3]. Join the group and see how the Growth Corporation uses the cut-and-paste and fill-in method to upgrade their quality manual to the Standard. Of course there is a very wise consultant on board.

In case study #2, a friend of Growth needs to create their first QMS based on the Standard, and has come to Growth for advice. Growth's vice president of quality assurance comes to the rescue and offers a plan that has been used to achieve Growth's 1994 certification and an ISO 9001:2000 upgrade certification using the design tools presented in this book. The same wily consultant helps out.

Several appendixes are also used to present more detail with regard to tool application. Adherence to the proposed design rules will create a documented, implemented, and systems-effective QMS that is fully compliant with the Standard, and makes a powerful statement about the organization's technical competence, commitment to quality, and enterprise uniqueness.

[1]By the end of 1999, 150 countries had adopted ISO 9000. The estimated "ISO 9000 third-party registration industry has had a combined economic impact of $4 billion." This data was reported in Quality Systems Update, McGraw-Hill Companies, Vol. 10, No. 7, Fairfax, VA, July 2000. A later report by Quality Systems Update (QSU Publishing Company, Vol. 12, No. 7, July 2002, p. 1) indicates that the worldwide total of ISO 9000 registration certificates now stands at 510,616 in 161 countries.

[2]Reported in Quality Systems Update, McGraw-Hill Companies, Fairfax, VA, June 2001 and March 2001 publications; and in The Environmental Management Report by the same company in the June 2001 publication. Please note that the term certification is used to denote the receipt of a certificate from an ISO 9000 registrar. The registrar then places the site on their list of certified organizations and in this manner the organization is registered.

[3]The choice of configuration is not meant to imply a so-called best approach. It simply represents the most common form of quality policy manual that I have found in working with over 142 manuals. The tier II, III, and IV documentation described is also based on the most common forms of processes, procedures, and forms that I have observed. I occasionally still come across integrated manuals. They are a problem for some third-party assessors because of their uniqueness, but that is the assessor's problem, not the supplier's.

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