1、The ISO 9000EssentialsA Practical Handbook for Implementing the ISO 9000Family of StandardsPLUS 9001 4th EditionPublished in March 2009 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-74
2、7-4044Visit our Online Store at www.ShopCSA.caPLUS 9001The ISO 9000 EssentialsA practical handbook for implementing the ISO 9000 family of standardsCSA Special PublicationISBN 978-1-55491-063-2Technical Editor: David Zimmerman Canadian Standards Association 2009All rights reserved. No part of this p
3、ublication may be reproduced in any form whatsoever without the prior permission of the publisher.ISO material is reprinted with permission.100%The Canadian Standards Association (CSA) prints its publications on Rolland Enviro100, which contains 100% recycled post-consumer fibre, is EcoLogo and Proc
4、essed Chlorine Free certified, and was manufactured using biogas energy.Technical EditorDavid ZimmermanCanadian Standards AssociationMississauga, OntarioContributors:Peter Papakostantinu Robert T. MarshallPapa and Associates Inc. R.T. Marshall AssociatesToronto, Ontario Toronto, OntarioAcknowledgeme
5、ntsFigures and tables were kindly provided by Denis Pronovost of Accademia Qualitas, a private organization that teaches the application of ISO 9000 principles.Published byCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, OntarioCanada L4W 5N6For information about this Handbook,
6、 and to order copies of publications referenced in it, please contact Canadian Standards Association at the address given above or call 1-800-463-6727.Contents Canadian Standards Association The ISO 9000 EssentialsMarch 2009 iiiPreface 1Layout of this handbook 2Abbreviations 20Introduction 30.1 Gene
7、ral 30.2 Rationale for QMS 30.3 The ISO 9000 phenomenon 41 The process approach 51.1 Overview 51.2 Changes in ISO 9001 82 Conceptual overview 82.1 Quality management principles 82.2 Requirements for products and requirements for quality management systems 102.3 Relationship between ISO 9001 and ISO
8、9004 112.4 The scope of a QMS 132.5 Application of ISO 9001 142.6 Exclusions 142.6.1 Justification of exclusions 142.6.2 Most likely exclusions 152.6.3 Requirements that may not be excluded, and claims of conformity 152.7 Subcontracted or “outsourced” processes 152.8 Certification/registration 162.9
9、 Examples 173 An implementation path 193.1 Accreditation of registrars 193.2 Typical project 193.2.1 Overview 193.2.2 Management decision and commitment 213.2.3 Project planning and assignment of responsibility 223.2.4 Training key resources 223.2.5 Initial internal assessment 233.2.6 Documentation
10、development 233.2.7 Implementation of procedures 243.2.8 Internal auditing or pre-assessment 253.2.9 Registration audit 26PLUS 9001 Canadian Standards Associationiv March 20093.3 Outside assistance 283.3.1 Overview 283.3.2 Acquiring knowledge and abilities 283.3.3 Acquiring expert resources 293.3.4
11、Interpretations 313.3.5 Internal audits 313.3.6 Usefulness of audit conclusions 323.3.7 Measuring and monitoring the audit processes 323.4 Scope, references, and definitions of ISO 9001:2008 344 Quality management system 374.1 General requirements 374.2 Documentation requirements 404.2.1 General 404
12、.2.2 Quality manual 454.2.3 Control of documents 464.2.4 Control of records 485 Management responsibility 525.1 Management commitment 525.2 Customer focus 535.3 Quality policy 545.4 Planning 555.4.1 Quality objectives 555.4.2 Quality management system planning 555.5 Responsibility, authority and com
13、munication 575.5.1 Responsibility and authority 575.5.2 Management representative 575.5.3 Internal communication 585.6 Management review 605.6.1 General 605.6.2 Review input 605.6.3 Review output 606 Resource management 636.1 Provision of resources 636.2 Human resources 636.2.1 General 636.2.2 Compe
14、tence, awareness and training 636.3 Infrastructure 656.4 Work environment 657 Product realization 677.1 Planning of product realization 677.2 Customer-related processes 70 Canadian Standards Association The ISO 9000 EssentialsMarch 2009 v7.2.1 Determination of requirements related to the product 707
15、.2.2 Review of requirements related to the product 737.2.3 Customer communication 757.3 Design and development 777.3.1 Design and development planning 777.3.2 Design and development inputs 827.3.3 Design and development outputs 847.3.4 Design and development review 857.3.5 Design and development ver
16、ification 887.3.6 Design and development validation 907.3.7 Control of design and development changes 927.4 Purchasing 967.4.1 Purchasing process 967.4.2 Purchasing information 987.4.3 Verification of purchased product 1007.5 Production and service provision 1027.5.1 Control of production and servic
17、e provision 1027.5.2 Validation of processes for production and service provision 1067.5.3 Identification and traceability 1107.5.4 Customer property 1137.5.5 Preservation of product 1167.6 Control of monitoring and measuring equipment 1188 Measurement, analysis and improvement 1248.1 General 1248.2
18、 Monitoring and measurement 1268.2.1 Customer satisfaction 1268.2.2 Internal audit 1288.2.3 Monitoring and measurement of processes 1318.2.4 Monitoring and measurement of product 1338.3 Control of nonconforming product 1358.4 Analysis of data 1408.5 Improvement 1428.5.1 Continual improvement 1428.5.
19、2 Corrective action 1438.5.3 Preventive action 147AnnexesA The ISO 9000 family of standards 149B ISO 9000:2005 Vocabulary 150C Changes between ISO 9001:2000 and ISO 9001:2008 166D Correspondence between ISO 9001:2008 and ISO 14001:2004 179E Bibliography, Internet resources, and contact information 1
20、87PLUS 9001 Canadian Standards Associationvi March 2009Tables1 Quality management principles 92 ISO 9001:2008 and ISO 9004:2000 113 Typical days to conduct an audit vs. size of the company being audited 274 Examples of records 49Figures1 Number of ISO 9001:2000 certificates as of 2007 52 QMS continu
21、al improvement diagram 73 Quality: Product and confidence 104 The quality management house 125 Typical project approach 216 Typical registration process 267 QMS documentation 428 Process control 689 Design and development acceptance 7810 Verification and validation 9011 Validation of processes (for
22、special processes) 10812 Process validation decision tree 10913 Corrective and preventive action 145 Canadian Standards Association The ISO 9000 EssentialsMarch 2009 1PLUS 9001A practical handbook for implementing the ISO 9000 family of standardsPrefaceThe primary objective of this handbook is to pr
23、ovide both novice and experienced quality practitioners with a concise, user-friendly guide to understanding and implementing the requirements of the ISO 9001 quality management standard. The ISO 9000 family of standards has undergone three revisions. Initially published in 1987, ISO 9001 was revise
24、d in 1994, 2000, and, most recently, in 2008. The first part of the handbook is made up of four subsections: “Introduction”, “The process approach”, “Conceptual overview”, and “An implementation path”. The “Introduction” outlines the background of the ISO 9000 family of standards. “The process appro
25、ach” introduces some of the basic concepts found in the ISO quality management system. “Conceptual overview” provides an understanding of the fundamentals associated with quality management systems (QMSs). Finally, “An implementation path” suggests an approach for QMS registration, and describes the
26、 process of conformity assessment by third-party registration bodies (registrars) and accreditation bodies.The second part of the handbook is also made up of subsections, which are numbered according to corresponding clause numbers in ISO 9001:2008. This containsthe actual text of ISO 9001:2008;guid
27、ance, providing an explanation of the intent of the ISO 9001:2008 standard;numerous definitions extracted from ISO 9000:2005;typical audit questions useful for organizations seeking to implement a QMS based on ISO 9001:2008; andself-diagnostic questions to be used by an organization while preparing
28、its quality management system.Some figures and tables were kindly provided by Denis Pronovost of Accademia Qualitas, a private organization that teaches the application of ISO 9000 principles.PLUS 9001 Canadian Standards Association2 March 2009Layout of this handbookAbbreviationsEDI: Electronic Data
29、 InterchangeEMS: Environmental Management SystemIAF: International Accreditation ForumIEC: International Electrotechnical CommissionISO/TC 176: International Organization for Standardization Technical Committee 176 Quality Management and Quality AssuranceOHSMS: Occupational Health and Safety Managem
30、ent SystemPCDA: Plan-Do-Check-Act methodologyQMP: Quality Management PrinciplesQMS: Quality Management SystemSCC: Standards Council of CanadaAll clauses of ISO 9001:2008 are reproduced in a text box.This section contains guidance extracted from the ISO Introduction and Support Package prepared by IS
31、O Technical Committee 176/ Subcommittee 2), or developed by members of the editorial team for this 4th edition of PLUS 9001, as well as information made available from the Canadian Advisory Committee to ISO (CAC/ISO/TC 176).This section contains information relevant to the service sector, e.g., hote
32、ls, insurance companies, training providers, governments.This section contains information relevant to computer software, in contrast to other types of intellectual software products such as music, movies, and stories.This section lists audit questions typical of those used by third-party QMS regist
33、rars.This section provides definitions of terms primarily from ISO 9000:2005. Notes contained in these definitions are not always included in this section, but are all included in Annex B.This section lists diagnostic questions to be considered by the organization while preparing its QMS. Canadian S
34、tandards Association The ISO 9000 EssentialsMarch 2009 30Introduction0.1 GeneralThe ISO 9000 family of standards was developed to assist organizations, of all types and sizes, to implement and operate an effective quality management system (QMS). It is made up of four core standards:(a) ISO 9000:200
35、5, entitled Quality management systems Fundamentals and vocabulary, describes the fundamentals of a QMS and specifies the terminology for a QMS.(b) ISO 9001:2008 specifies requirements for a QMS where an organization needs to demonstrate its ability to provide products that meet customer requirement
36、s and applicable regulatory requirements and aims to enhance customer satisfaction.(c) ISO 9004:2000, entitled Quality management systems Guidelines for performance improvement, provides guidelines for both the effectiveness and efficiency of the QMS. The aim of this standard is the improvement of t
37、he performance of an organization and the satisfaction of customers and other interested parties.Note: At time of printing, this standard is under development with a new edition planned for mid-2009.(d) ISO 19011:2002, entitled Guidelines for quality and/or environmental management systems auditing,
38、 provides guidance on auditing quality and environmental management systems, and was developed by both ISO/TC 176 and ISO/TC 207. The ISO/TC 207 is responsible for the ISO 14000 family of environmental management system standards.Together the four ISO documents form a coherent set of QMS standards f
39、acilitating mutual understanding for national and international trade.0.2 Rationale for QMSA QMS assists organizations in enhancing customer satisfaction. Customers require products with characteristics that satisfy their needs and expectations. These needs and expectations, expressed in product spe
40、cifications, are collectively referred to as “customer requirements”. Customer requirements may be specified contractually by the customer or may be determined by the organization itself. In either case, the customer ultimately determines the acceptability of the product. Because customer needs and
41、expectations tend to change, organizations are driven to continually improve their products and processes, since something which provided customer satisfaction in the past may be a source of customer dissatisfaction in the future.PLUS 9001 Canadian Standards Association4 March 2009The QMS approach e
42、ncourages organizations to analyze customer requirements, define the processes that contribute to the realization of product that meets the specified requirements, and to keep these processes under control. A QMS can provide the framework for continual improvement to enhance the satisfaction of cust
43、omers and other interested parties. It provides confidence to the organization and its customers that it can provide products that consistently fulfill requirements.0.3 The ISO 9000 phenomenonThe ISO 9000 family of standards was called a “phenomenon” a few years ago because, in just a few years, it
44、was successful in replacing national standards in the field of quality assurance around the world. The market acceptance of these standards was also quite spectacular, although some predicted that this acceptance would soon reach a plateau. However, the latest survey conducted by ISO indicates that
45、over one million certificates have been issued in 175 countries. Both numbers are astounding. Moreover, the number of certificates continues to grow. Certificates are only one indicator of the value that the ISO 9000 family provides to its users, as many organizations have implemented ISO 9001 witho
46、ut seeking certification. But they certainly are a good indicator of the worldwide acceptance of these standards.A quick look at different regions of the world shows that all of them are participating, from Central and South America with close to 30,000 all the way to Europe with over 415,000. Figur
47、e 1 illustrates the world total and world growth numbers. Canadian Standards Association The ISO 9000 EssentialsMarch 2009 5Figure 1Number of ISO 9001:2000 certificates as of 20071 The process approach1.1 OverviewISO 9001 promotes the adoption of a process approach when developing, implementing, and
48、 improving the effectiveness of a QMS, so as to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to identify and manage numerous linked activities. Activities use resources and are managed in order to enable the transformation of inp
49、uts into outputs, which can be considered to be a process. Often the output from one process directly forms the input to the next. Figure 8, “Process control”, illustrates an approach to controlling the expected results from any process within the QMS (i.e., those of Clauses 4, 5, 6, 7, and 8, not just those of Clause 7).The application of a system of processes within an organization, together with the identification and interaction of these processes and their management, can be referred to as the “process approach”. An
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