ISO 9001-2000 Quality Management System Design

Schlickman, Jay J., 1934–
ISO 9001:2000 quality management system design
p. cm.–(Artech House technology management and professional development library) Includes bibliographical references and index.
ISBN 1-58053-526-7 (alk. paper)
1. ISO 9000 Series Standards. I. Title. II. Series.
TS156.6 .S35 2003
658.5′62–dc21

PREFACE
The 20th century will be remembered as the Century of Productivity, whereasthe 21st century will come to be known as the Century of Quality. So predictsDr. Joseph M. Juran, father of the quality movement.—Joseph A. DeFeo, “The Future Impact of Quality” Quality Engineering, MarcelDekker, Volume 13, Number 3, 2001Why We Are Replacing 13 Million Firestone Tires: Ford Motor Company isreplacing all FirestoneWilderness 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 ofthe Firestone Wilderness AT tires not covered by last year’s recall could, atsome time in the future, experience increased failure rates.— Ford Motor Company Advertisement, Friday, May 24, 2001, The Boston Globe,p. A27Quality in a World of Globalization Without question, product quality isneeded 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, mostimportantly, oftentimes costs human life.The pursuit of product quality requires that an organization create a qualityframework. The ISO 9001:2000 quality management system (QMS) is aninternationally established quality framework. This book is designed to assistan organization to structure an ISO 9001:2000 QMS on some well-establisheddocumentation and implementation concepts that have been proven to beeffective based on ten years of intensive consulting and auditing experienceswith 106 ISO 9000–certified organizations. The intent of this exercise is toprovide the reader with a reasonable probability of maximized organizationalproductivity when the ISO 9001:2000 system is implemented.
The book’s objective is to establish an engineering design approach to createa compliant ISO 9001:2000 QMS. Our design rules are constructed to effectivelyminimize documentation in a way that still increases implementationusage and fosters a dynamic demonstration of continual improvement.An effectively designed QMS should do the following:◗ Unify the organization’s economic needs with its quality requirements;◗ Optimize the flow of information to a wide range of users;◗ Maintain full compliance with the ISO 9001:2000 International Standard(Standard);◗ Provide a dynamic presentation of the organization’s drive towards ameaningful ISO 9000 QMS;◗ Propose a resolution as to just what a quality manual should containand thereby provide a basis for a less diverse set of practitionerinterpretations.The book’s approach is based primarily upon an interpretation of therequirements stated in the Standard and its associated guidelines. The directivesare encased within the context of 39 years of experience in the managementof high-tech research, engineering, marketing and sales, quality,manufacturing, and service organizations.Although the design rules are generic, the text covers 1994–2000 upgradesin detail (the cut-and-paste and fill-in techniques) because over 400,0001994-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 secondcase study is designed for someone who needs to create a QMS from theground floor using the book’s design rules. The second case study is muchshorter, as the first case study ends up with a complete quality manual that, intone and structure, is similar to a first created quality manual.Origins The ISO 9000 schema has matured to the point that it contains itsown scholarship, mythology, and sibling conflicts. The program has transitionedto one of big business, complete with a plethora of international accreditationboards, registrars, trainers, and consultants under contract to thousandsof global organizations. We have termed this group of entrepreneurs the ISO9000 practitioners [1].Every week, the ISO schema becomes more entrenched into the fabric ofbusiness and society (e.g., the certification of Nasdaq’s computer and networkoperations, facilities and technical services to ISO 9001; the development of FSxviii Preface9000 for the financial sector; and the United States Army’s planned adoptionof ISO 14001 by 2005 [2]).The ISO 9000 practitioners work within an exciting and dynamic environmentthat now fosters a myriad pattern of standards and interpretations ofthose standards. It is this book’s intention to make a significant contribution tothe clarification of this broad range of perspectives—both for those who wishto create an effective QMS and for those who audit those systems.It is my privilege, as an independent subcontractor, to work with thisgroup of remarkable talents on both sides of the ISO 9000 street. This situationhas afforded me the opportunity to serve as a consultant and both assessor andauditee within the ISO 9000 certification process. Hopefully, this has also providedme a more balanced view in my role as provocateur. My ISO 9000 experiencewith over 100 organizations has been extremely positive, and it is mywish to share this unique opportunity with the entire ISO 9000 community.It is this book’s contention that a successful implementation of ISO9001:2000 in any type of organization is the result of a fully compliant andstrategically driven QMS. The design platform described in the book consistsof a set of design tools that can create a fully compliant QMS whose fabric isan organization’s strategic business declaration.In most cases, ISO 9000 QMSs are difficult to document, implement, andmaintain. The greatest difficulty lies in the demonstration of continualimprovement. The lessons learned during my experiences with over 100 systemsshould not be lost but should be documented for others to evaluate andutilize to create their own effective ISO 9000 QMS. The effort required to createa QMS that conforms to the 2000 revision is no less and perhaps abit greater than a QMS that conformed to the 1994 version. However, theversions are decidedly different in structure and tone. We hope that this bookwill clarify the differences for the certified-experienced readers and establish aclear structural context for those readers in the midst of their first certification.This book will prove useful to those organizations that have already createda 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 theneed to create documentation that addresses a broad audience. It is also themost difficult aspect of this design approach, and we have worked diligently toillustrate how a QMS can be designed to provide the required information forall system users.Although the book has been written at a technical level designed to revealthe operational beauty and power of the Standard, the conceptual nature ofthe Standard is not easily envisioned because of its hierarchal nature anddescriptive style. We have worked very diligently to clarify and to offer alternativeways to address such issues.
Specifically, the text has been written for a diverse audience comprisingthe following:◗ Executives who wish to understand what an effective QMS looks likeand want to ensure that the system is economically feasible and in concertwith the organization’s strategic goals;◗ Members of steering committees, stewards, process champions, and ISO9000 management representatives who must decide on the scope anddesign detail of theQMSconfiguration and who must ensure that the systemis effectively implemented;◗ Operational and audit team members who need to understand how towrite an effective set of ISO 9000 documents and how to make sure thatthe system is measured effectively and contains a dynamic corrective andpreventive action process;◗ ISO 9000 practitioners who are interested in the study of self-consistentQMS configurations and what it is like to work on the other side of thetable;◗ Training course suppliers who can use the book as either a researchsource or as the day-to-day text.Part Content This book establishes a set of design rules for effective QMScreation. In particular, the need for full compliance to each requirement (writtenas SHALL) of the Standard is addressed in detail. For completeness, severalother system design configurations and strategies are also addressed, though inless detail. The overall structure of the book follows a hierarchal flow that firstconsiders the total QMS design issue and then deals separately with the designof the quality manual, standard operating processes and procedures, workinstructions, forms, and records, as well as a number of important supplementaldesign topics.
Part I establishes the basis for QMS design. It is imperative that the QMS betransparent to the overall strategic goals and objectives of the organization. Toformalize this concept, this section deals with several possible choices uponwhich to base an integrated strategic and quality-based QMS design. The ISO9001:2000 International Standard is chosen for further exposition because of itsinherent international and national certification advantage. The fundamentalsof ISO 9001:2000 QMS design are then discussed in detail (e.g., the three pillarsof documentation, implementation, and demonstration of effectiveness thatsupport QMS operational integrity; the QMS process model; continual/continuousimprovement cycles; and mandatory documentation requirements).
Part II deals with QMS documentation design and establishes a four-tierdocumentation hierarchy as the basis for an effectively documented QMS. Thecritical role of the quality manual as a key driver to overall QMS effectivenessis discussed in detail. Then, the lower tier documentation (i.e., processes, procedures,forms, records, and other mandatory documents) is addressed interms of optimum documentation structure and their specific roles in theQMS hierarchy.
Part III deals with QMS implementation and discusses organizationalissues 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 9001version, (i.e., the organization must now continually improve QMS effectivenessand accomplish this task via quantitative analysis of QMS performance).The critical area of quality objective design is then discussed in some detail inregard to formulation, implementation, and analysis.
Part V discusses QMS styles. The topics of inherent, broad readershiprequirements; the negative impact of a paraphrased manual; publicationmedia choices, and effective writing styles are addressed to illustrate theirimpact on QMS effectiveness.
Part VI blends all of the tools together and summarizes their use in thecreation of a fully compliant and strategically business-oriented QMS. This setof 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 thatwill need to be upgraded to the new Standard. Many thousands more willneed to create their first manual in conformance with the Standard. As aresult, we have created two case studies:The first case study describes the upgrade and recertification of the GrowthCorporation from ISO 9001:1994 to ISO 9001:2000. The exercise is based on awholly fictitious (although you may spot yourself) but completely formedhigh-tech organization that utilizes this book’s set of design tools. The corporationchooses a cut-and-paste and fill-in approach to electronically cut up theold manual:1994 into the new manual:2000. The result is a stand-alone formof quality manual in which the sections directly form a complete and compliantmanual:2000 contained within this book.1 Join the group and see how theGrowth Corporation uses the cut-and-paste and fill-in method to upgrade
1. The choice of configuration is not meant to imply a so-called best approach. It simply represents the mostcommon 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 formsthat I have observed. I occasionally still come across integrated manuals. They are a problem for somethird-party assessors because of their uniqueness, but that is the assessor’s problem, not the supplier’s.their quality manual to the Standard. Of course there is a very wise consultanton board.In case study #2, a friend of Growth needs to create their first QMS basedon the Standard, and has come to Growth for advice. Growth’s vice presidentof quality assurance comes to the rescue and offers a plan that has been usedto achieve Growth’s 1994 certification and an ISO 9001:2000 upgrade certificationusing the design tools presented in this book. The same wily consultanthelps out.Several appendixes are also used to present more detail with regard to toolapplication. Adherence to the proposed design rules will create a documented,implemented, and systems-effective QMS that is fully compliant with theStandard, and makes a powerful statement about the organization’s technicalcompetence, commitment to quality, and enterprise uniqueness.