ISO 9001 The Standard Interpretation - A Peek Between the Covers

Published by Simply Quality

Preface

ISO 9000 is a series of documented standards prescribing quality assurance management. Written by the International Organization for Standardization, the series has been adopted by 80 countries, including the United States, Canada, the European Union and Japan. ISO 9001 has the broadest scope of these standards and is intended to be used for four purposes:

The 9001 Standard presents a basic model for Quality Assurance. When requirements of the Standard are met, customers can be confident of the quality of products and services they purchase.

The ISO 9001 Standard is used in legally binding contracts, so its language must be precise. However, it must also be general enough to apply to all industries. The result is that although the Standard is fewer than ten pages long, it is difficult to read and understand. The purpose of this book is to present each paragraph of the Standard, then increase the reader's understanding with a discussion and checklist.

In its most basic form, the Standard requires that you:

The bulk of the book is made up of units, each consisting of the following four sections:

ISO 9001 Heading                     Simple Heading                        
The exact text of the ISO 9001       A simplified rephrasing of the        
Standard.                            Standard heading followed by a        
                                     simplified introduction to the text   
                                     of the Standard. This is intended to  
                                     provide the reader with an overview   
                                     of the text of the Standard. Because  
                                     simplifications and interpretations   
                                     are made here, the actual text of     
                                     the Standard should be referred to    
                                     for critical decision-making.

Discussion:

Notes on, or examples of, the best or most common practices to use in carrying out the Standard.

Checklist:

A list of questions, based on this section of the Standard, that is representative of those asked by an auditor. These may be used as a checklist to assess your organization's readiness during compliance efforts or may be used as the basis for internal audits. To be in compliance, you must be able to provide objective evidence supporting a "yes" answer to any checklist question. Note that although these are valid questions and the list is intended to be comprehensive, currently no checklists are sanctioned by the International Organization for Standardization (ISO). The actual questions asked by any auditor will differ from those on this list.

Changing each question into a positive statement for action will provide a list of practical directives on how to implement each paragraph of the Standard.

Special Use Terms:

Several terms throughout the Standard have a more precise meaning than they do in common usage. They can be defined as follows:

These definitions are used throughout this book instead of the original terms. Other terms used in the Standard may be unfamiliar, and are defined in a glossary at the end of the book.

It is helpful to know that the scope of the Standard is work affecting the quality of a product or service. And the test for a sufficient Quality System is its "effectiveness." Therefore, in assessing compliance, the auditor, who is trained to evaluate compliance with the Standard, will determine whether a person's work affects product and service quality and if the Quality System is effective in preventing errors. In an effective Quality System, if errors do happen, they are quickly detected and corrected .

Interpretation of the Standard will vary from one auditor or consultant to the next and from one registration agency to the next. This book describes an interpretation based on the practices of several auditors. The exact interpretation used by any individual auditor can only be made by that auditor.

Summary and Afterword

The twenty paragraphs, 4.1 through 4.20, of the Standard are interrelated and form a Quality Assurance System. The table on the last page of this book is an overview of those paragraphs, showing how they support each other. The figures on pages 97 and 98 illustrate the interrelationships between several elements.

It is vital that top management actively support the achievement of product and service quality by creating and deploying a written quality policy; defining the organization and structure of staff responsible for product and service quality; providing for inspectors, independent auditors and reviewers; assigning an ISO 9001 Management Representative with the authority to carry out the requirements of the Standard, and personally reviewing the results of the internal audits.

A Quality System is created and maintained by keeping a comprehensive set of controlled procedures documents, and having the resources needed to achieve quality.

All phases of product design, development, manufacture, installation and service, from review of the sales agreement with the customer, through all intermediate stages of product design, selection and control of suppliers, identifying, testing and controlling the product during its creation, handling, storage, packaging and delivery and providing customer service, are carried out with care for product and service quality.

Work that affects product and service quality is conducted through controlled processes. This requires that the processes are effectively managed by establishing defined procedures, controlling documentation, maintaining records of results and authorizations, auditing the Quality System to keep it current, taking corrective and preventive action, calibrating measuring and test equipment and using only valid statistical techniques.

To allow all of this to happen, people are qualified to carry out their work based on their education, training or experience.

ISO 9001 presents a basic model for quality assurance. I hope this book helps you to understand and appreciate the Standard. Deciding to obtain registration is an excellent next step, or first step, in your quality journey. I hope you will take that step, it is well within your reach.

When you do obtain registration, please tell me your experiences. Let me know how this book was most helpful and where it can be improved.

Changes Made in the 1994 Version of ISO 9001

Directives of the International Organization for Standardization require that all standards be reviewed every five years. The purpose of this review is to ensure that:

As a result, the ISO 9000 series of standards has been revised and officially adopted in July 1994. The most significant changes from the 1987 version of ISO 9001 are as follows: