1、ISO 9001:2008 for Small and Medium-Sized BusinessesH1385_Robitaille.indd 1 8/2/10 10:32 AMDenise E. Robitailles other books include:The Corrective Action HandbookCorrective Action for the Software IndustryManaging Supplier-Related ProcessesThe Management Review HandbookThe Preventive Action Handbook
2、Root Cause Analysis: Basic Tools and TechniquesDocument Control: A Simple Guide to Managing DocumentationAlso available from ASQ Quality Press:A Practical Field Guide for ISO 9001:2008Erik Valdemar MyhrbergISO 9001:2008 Explained, Third Edition Charles A. Cianfrani, John E. “Jack” West, and Joseph J
3、. TsiakalsISO Lesson Guide 2008: Pocket Guide to ISO 9001-2008, Third EditionJ. P. Russell and Dennis R. ArterISO 9001:2008 Internal Audits Made Easy: Tools, Techniques and Step-By-Step Guidelines for Successful Internal Audits, Second EditionAnn W. PhillipsProcess Driven Comprehensive Auditing: A N
4、ew Way to Conduct ISO 9001:2008 Internal Audits, Second EditionPaul C. PalmesISO 9001:2008 Interpretive Guide for the Design and Construction Project Team (e-Book)Prepared by members of the ASQ Design and Construction Division and edited by John R. BroomfieldHow to Audit the Process-Based QMSDennis
5、R. Arter, John E. (Jack) West, and Charles A. CianfraniQuality Audits for Improved Performance, Third EditionDennis R. ArterTo request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at http:/www.asq.org/quality-press.H1385_Robitaille.indd 2 8/2/10
6、 10:32 AMISO 9001:2008 for Small and Medium-Sized BusinessesSecond EditionDenise E. RobitailleASQ Quality PressMilwaukee, WisconsinH1385_Robitaille.indd 3 8/2/10 10:32 AMAmerican Society for Quality, Quality Press, Milwaukee 53203 2011 by ASQAll rights reserved. Published 2010Printed in the United S
7、tates of America16 15 14 13 12 11 10 5 4 3 2 1Library of Congress Cataloging-in-Publication DataRobitaille, Denise E., 1952. ISO 9001:2008 for small and medium-sized businesses / Denise E. Robitaille. 2nd ed. p. cm. Prev. ed. had title: ISO 9001:2000 for small and medium-sized businesses. Includes i
8、ndex. ISBN 978-0-87389-792-1 (alk. paper) 1. ISO 9001 Standard. 2. Quality assurance. 3. Quality control. I. Robitaille, Denise E. ISO 9001:2000 for small and medium-sized businesses. II. Title. TS156.6.R64 2010 658.4013dc22 2010028236No part of this book may be reproduced in any form or by any mean
9、s, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.Publisher: William A. TonyAcquisitions Editor: Matt MeinholzProject Editor: Paul OMaraProduction Administrator: Randall BensonASQ Mission: The American Society for Quality advances
10、 individual, organiza-tional, and community excellence worldwide through learning, quality improve-ment, and knowledge exchange.Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases fo
11、r business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.To place orders or to request a free copy of the ASQ Quality Press Publications Catalog, including ASQ membership i
12、nformation, call 800-248-1946. Visit our Web site at http:/www.asq.org/quality-press.Printed on acid-free paperH1385_Robitaille.indd 4 8/2/10 10:32 AMvContentsList of Figures and Tables ixPreface xiChapter 1 ISO 9001 and Small and Medium-Sized Businesses 1What Is ISO 9001? 1What Do We Mean by “Small
13、 and Medium-Sized”? . 1Why 9001? 3A Few Words about Registrars . 6Getting Going 8Chapter 2 Overview of ISO 9001:2008 . . 11The Quality Management Principles 12Overview of ISO 9001:2008 . . 19Chapter 3 ISO 9001:2008 Introduction . 250.1 General 250.2 Process Approach 270.3 Relationship to ISO 9004 28
14、0.4 Compatibility with Other Management Systems . . 29H1385_Robitaille.indd 5 8/2/10 10:32 AMvi ContentsChapter 4 ISO 9001:2008 Sectionsuni00A01,uni00A02,uni00A0and 3 . . 31Section 1: Scope 31Section 2: Normative Reference . 35Section 3: Terms and Definitions . 36Chapter 5 ISO 9001:2008 Section 4 39
15、4.1 General Requirements . . 394.2 Documentation Requirements . . 49Chapter 6 ISO 9001:2008 Section 5 655.1 Management Commitment . 655.2 Customer Focus . 665.3 Quality Policy . . 665.4 Planning . 675.5 Responsibility, Authority, and Communication . 705.6 Management Review . 72Chapter 7 ISO 9001:200
16、8 Section 6 816.2 Competence, Training, and Awareness . 826.3 Infrastructure and 6.4 Work Environment 85Chapter 8 ISO 9001:2008 Section 7 897.1 Planning for Product Realization 907.2 Customer-Related Processes . 917.3 Design and Development 947.4 Purchasing . 987.5 Production and Service Provision .
17、 1017.6 Control of Monitoring and Measurement Equipment 108H1385_Robitaille.indd 6 8/2/10 10:32 AMContents viiChapter 9 ISO 9001:2008 Section 8 1138.2 Monitoring and Measurement . . 1138.3 Control of Nonconforming Product . 1198.4 Analysis of Data . 1208.5 Continual Improvement . 122Appendix Related
18、 ISO Standards from TC 176 . 127Index 129H1385_Robitaille.indd 7 8/2/10 10:32 AMH1385_Robitaille.indd 8 8/2/10 10:32 AMixList of Figures and TablesTable 4.1 Evidence for justification of exclusion . . 35Table 4.2 Commonly used terms and definitions from ISO 9000:2005 . . 36Table 5.1 First-round brai
19、nstorming of processes 41Table 5.2 Organization of processes . . 43Figure 5.1 Interrelation of processes . 44Figure 5.2 QMS processes . . 45Figure 5.3 Documentation structure tiered model . . 51Table 5.3 Examples of documents of external origin 58Table 5.4 Records required by ISO 9001:2008 . . 60Tab
20、le 6.1 Examples of quality objectives . 68Table 6.2 Management focus vs. ISO 9001 review requirements . 74Table 6.3 Tips and examples for management review . 76Figure 9.1 Example of return on investment for effective corrective action . . 125H1385_Robitaille.indd 9 8/2/10 10:32 AMH1385_Robitaille.in
21、dd 10 8/2/10 10:32 AMxiPrefaceThis handbook was developed to help small and medium-sized organizations better understand ISO 9001:2008. It is intended to facilitate implementation and improve-ment. The establishment, implementation, and maintenance of an ISO 9001compliant quality management system (
22、QMS) should allow the organization to experience multiple benefits beyond the achievement of certification. Organizations should also see improvements in the quality of products, customer sat-isfaction, and process effectivenessall of which ultimately have a positive impact on the bottom line.For th
23、ose readers whose organizations have already estab-lished a QMS, this handbook will serve to reinforce good prac-tices and lead to a better understanding of the intent and value of some of the requirements of ISO 9001. Since this handbook is especially focused on small and medium-sized organizations
24、, the examples provided will have greater applicability and will enhance comprehension, again resulting in increased value.Many organizations have also implemented sector-specific standards based on ISO 9001. Examples of QMS standards based on ISO 9001 include AS9100 (for aviation, space, and defens
25、e), ISO/TS 16949 (for automotive), ISO 13485 (for med-ical devices), and ISO 17025 (for laboratory accreditation). This handbook should be equally useful to these organizations H1385_Robitaille.indd 11 8/2/10 10:32 AMin understanding the requirements that are common to all of these standards.In 2008
26、, a minor revision was issued to ISO 9001. It is not necessary to have an understanding of the distinctions between ISO 9001:2008 and any previous version in order to use this handbook.Terminology will be discussed in Chapter 4; however, there are two terms that bear particular note, and their use s
27、hould be clarified from the onset.The word product is intended to mean the output of a series of processes that is delivered to a customer. This may include service in those cases where an organizations “product” is a service. Some examples might include transportation, training, after-market servic
28、ing of a sold product, financial portfolio management, and healthcare. Note that in each case, the prod-ucts sound more like activities than what we traditionally think of as productsthat is, tangible goods. ISO 9001 has grown and diversified. There has been an explosion in the number of organizatio
29、ns providing service-type products that are required to conform to international QMS standards. In this handbook, an effort is made to standardize the use of the word product to encompass all organizations. However, where it can provide greater clarity, the word service is occasionally used.The othe
30、r word that bears special consideration is orga-nization. ISO 9001s diversification has resulted in a prolif-eration of certifications among nonprofit, educational, and governmental entities. Hence, the generic use of organiza-tion is universally applicable. Except in those cases where it clearly ma
31、kes more sense to use the word business, the word organization is used.Finally, one of the great characteristics of organizations is their variety. Products, processes, markets, internal cultures, size, assets, and constraints all contribute to the tableau that is your unique organization. Your QMS
32、must reflect your organization. xii PrefaceH1385_Robitaille.indd 12 8/2/10 10:32 AMPreface xiiiIt should be reflective of your relationship with your custom-ers and your commitment to fulfilling their requirements. There is no cookie-cutter QMS. ISO 9001:2008 defines the require-ments, but it does n
33、ot dictate the method of application. Utiliz-ing this handbook should allow you to develop or rejuvenate your QMS so that it is a benefit to both you and your customer.H1385_Robitaille.indd 13 8/2/10 10:32 AMH1385_Robitaille.indd 14 8/2/10 10:32 AM1WHAT IS ISO 9001?ISO 9001 is an international stand
34、ard that defines the require-ments for establishing a system to manage your organization and processes to better serve your customers.This standard does not reinvent your company, nor is the process for implementation difficult. Its a logical methodol-ogy based on how you run your business. It bring
35、s consistency and control to everyday practices. The basic philosophy is: “Do what you say and say what you do!” Further, it augments the effectiveness of processes by providing requirements that help you monitor and analyze key performance indicators for main-tenance and improvement.Over one millio
36、n organizations around the globe are certi-fied to ISO 9001. The standard has been in place for almost 20 years. Companies utilizing this international standard come from varied fields and industries. Companies as small as one person have been certified.WHAT DO WE MEAN BY “SMALL AND MEDIUM-SIZED”?Tr
37、aditionally, companies with fewer than 50 people are con-sidered small, whereas those with up to 500 employees are 1ISO 9001 and Small and Medium-Sized BusinessesChapter OneH1385_Robitaille.indd 1 8/2/10 10:32 AM2 Chapter Oneconsidered medium-sized. There is no precise definition, no exact number. F
38、or example, an organization can have 90 peo-ple, but if 80 of them perform the same routine tasks and top management is encompassed by only two individuals, it might be considered a small business. Conversely, with the advent of virtual technology, a medium- to large-sized software company could eas
39、ily have fewer than 50 employees. The multiplicity and intricacy of processes, assets, tiers of middle management, use of subcontractors, and complexity of the product also con-tribute to the determination of “small” versus “medium-sized.”Financial institutions and agencies such as the U.S. Small Bu
40、siness Administration (SBA) have specific criteria for small businesses used to determine financial assistance and loan quali-fication. This handbook does not adhere to those strict guidelines.Therefore, depending on the purpose of the categorization, any reasonable definition is correct. Ultimately
41、, the decision is yours. You get to decide if you consider your organization to be small or medium-sized. It is not particularly relevant to the utility of this handbook. Suffice it to say that this handbook has broad applicability.Its important to keep in mind that smaller organizations do tend to
42、share similar characteristics. They tend to have fewer individuals in top management or middle management. They often have less complicated processes. That, in turn, often means fewer documents. However, that isnt always the case. A small design firm might have many, many documents.Smaller organizat
43、ions have fewer people, so there tends to be extensive cross-training. One individual may wear many hats. In organizations with fewer than 20 people, its more likely that individuals will have multiple tasks. Perhaps the most ubiquitous example is the shipper/receiver. This individ-ual has responsib
44、ility for both functions. Yet in an ISO 9001 system, those processes are considered to be separate and unique. Shipping is generally the next sequential process after manufacturing or final inspection. The requirements are found H1385_Robitaille.indd 2 8/2/10 10:32 AMISO 9001 and Small and Medium-Si
45、zed Businesses 3in subclause 7.5.5. Receiving is a process directly related to the purchasing function and more closely associated with sub-clause 7.4.3. So you have one person and one job description but two distinct processes.Communication occurs differently in smaller organiza-tions. Theres usual
46、ly only one location and one building. Consequently, communication is generally face to face, and internal e-mails are less frequent. Meetings tend to be less for-mal, and changes are implemented with minimal bureaucracy. This doesnt absolve the organization from the requirements for well-controlled
47、 documentation and record retention. It simply means that it will occur differently than it would in a large corporation where, for example, engineering change notices might need approvals from process owners on three continents.Implementing a quality management system (QMS) is not easier or harder
48、in a small organization than it is in a large one. Resources are different; each has its own unique challenges, constraints, and advantages. The thing to always bear in mind is that this is your organization and these are your processes.WHY 9001?ISO 9001:2008 is the most widely used QMS standard in
49、the world. Theres good reason for its success. Simply stated, it works.There are a variety of reasons for implementing a QMS. Before continuing, its worth reviewing the value and benefits of your implementation project. The following sections discuss some of the great reasons for establishing and implementing an ISO 9001 QMS.To Improve the Way the Company Does BusinessThis is the single best reason for “doing ISO.” It will help you improve your organization. It will help by bringing consistency and definition to processes, which will res
