Manager's Guide to ISO 9000 - Hardcover

Chapter 1

WHAT IS ISO 9000, AND WHERE DID IT COME FROM?

ISO 9000 is one of the more misunderstood series of standards in common use today. After leading a manufacturing facility into compliance with and certification to ISO 9001 and providing direction and resources to bring a chemical manufacturing facility into compliance with ISO 9002, I can say without hesitation that the ISO 9000 series of standards is not solely a quality control standard.

But if ISO 9000 is not a quality control standard, what is it? The standard is a guideline for the design, manufacture, sale, and servicing of a product. For the purpose of this book, a product can be defined as either hard (for example, a car, computer, or sheet of paper) or soft (such as the service provided by a bank, information provided by a computer, or a design file or specification). To implement this standard successfully, the team working to establish the system must view the ISO 9000 series as a complete design, manufacturing, sales, and servicing standard. The system developed must concentrate on consistency of purpose and focus on the requirements of doing business well. In summary, ISO 9000 is nothing more than a checklist for doing business on a world-class level.

The ISO 9000 standard is a unique document. It was written in such a way that it can be successfully implemented in almost any type of business without modification or change. It has been implemented in health care institutions, banks, chemical manufacturing companies, heavy blacksmith-type manufacturing shops, pharmaceutical manufacturers, and food processing plants. The ISO 9000 standard is different from many of the existing quality standards in that it does not require specific actions to be carried out. Many standards state in exacting detail the amount of NDE required, the amount and type of incoming inspection required, how to document in-process or final inspection, or what is required in an inspection and test plan. ISO 9000 does not take this approach.

For this reason, ISO 9000 encourages each company to determine how best to meet the intent and requirement of the standard. This allows for flexibility and individualization of a company's method of operation. The underlying philosophy suggests that each business must address specific elements (design control, purchasing, product qualification, and so forth) in order to be successful. The authors of this standard have effectively defined the areas of business that must be properly addressed for a company to produce a consistent product. The list of these areas was compiled into a group of documents called ISO 9000, 9001, 9002, 9003, and 9004. These documents define the requirements within each area that must be satisfied before a program can be certified.

A Word of Warning

It is only fair that I explain my viewpoint of ISO 9000 very early in this text. While working on this project I received two criticisms from a national quality society. The first was that I have taken a very "European" view of the standard. To this criticism, I plead guilty. I have been involved in directing the efforts of a manufacturing facility making oil-field stimulation equipment certified to the European standards BS 5750: Part 1, ISO 9001, EN 29001; 1987. I have also helped a chemical manufacturing plant develop a quality system certified to BS 5750: Part 2, ISO 9002, EN 29002; 1987. The certification body in each activity was the Norwegian firm Det Norske Veritas Quality Assurance LTD, and the audit team did its work within the guidelines of the British scheme. I have developed this view as the certification program was initiated to allow both companies to compete better in Europe. As a result, I do have a European view of this standard.

I feel the approach outlined by ISO 9001 (be it European or American) is one that allows a company to use the standard as an improvement tool. The standard can be used as the structure through which to implement a Total Quality Management (TQM) program. The standard will allow a company to truly have a quality program that will pay for itself instead of being a drain.

If this is a European view, so be it. It is about time someone determined that quality programs must be custom fit to a company instead of the one-size-fits-all approach that many of the existing standards try to take.

This leads us to the second criticism made by the quality society, which was that this book was not written to describe in detail exactly how a program must be implemented to pass the certification audit. In other words I have not tried to develop a generic program that, if followed, might result in a certification. To this criticism, I also plead guilty. This book does not detail a program down to the percentage of parts that have to be inspected using military standard 105D, nor does it define who is required on a material review board, or how many copies of a form must be made. After having spent three years dissecting the ISO 9000 series standard, I can say without reservation that this series is one of the most forward-thinking approaches that has ever been taken for a quality system document. This series of standards has not taken a cookie-cutter approach to implementation, where everyone must do the same things and have the same programs. It provides overall direction while allowing the creativity generated from within each company to determine how best to implement the standard.

The International Organization for Standardization has taken the innovative approach that ISO 9001, 9002, and 9003 are minimum guidelines that should be followed for a company to do business well. This group of professionals understood that to dictate the detail of implementation would in itself doom this standard to a state of obsolescence before the ink dried on the paper. Why should anyone override this effort by publishing a work that tries to push a personal view of how a quality program should function? The standard allows for innovation and improvement; a generic program can be neither cost-effective nor certifiable in all industries. The lack of specific program structure is the strong point of this standard.

What this book will do is look at each element of the standard, outline the intent, list the requirements, and give an example of an implementation strategy that has worked. I stress that the implementation strategy is an example of how the standard was implemented in a certified program, not a mandate for how it must be implemented. Find out what works well for your company and decide if what you are doing meets the intent of the standard, fulfills the requirement, and makes sense. If you can answer yes to each area, the program will probably pass a certification audit.

What About the 1994 Version?

This text was written in relation to the 1987 version of the ISO 9000 series standard. In March 1993, the first recommended revisions to the European series standard were presented to the member countries for possible ratification. The draft standard was referred to as ISO/DIS 9000 through ISO/DIS 9004. The member countries evaluated the standard and in September 1993 voted to accept the content of the modifications to the ISO 9000 standard. The modified standard will be issued in the spring of 1994 with the U.S. version being issued through the American National Standards Institute in late spring of 1994.

The American National Standards Institute has given us permission to reprint the 1987 version of ISO 9001 and 9004 along with reprinting any portions of the ISO/DIS 9000 series that we felt necessary to adequately present this topic. The verbiage of ISO 9001 and 9004 as cited in this book will be that of the 1987 versions as the revisions incorporated by the 1994 version have not altered the intent or basic requirements of the standard. The major revisions have prov