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E-raamat: ISO 9001:2015 Audit Procedures

(Herne European Consultancy Ltd, UK)
  • Formaat: 306 pages
  • Ilmumisaeg: 01-Jul-2016
  • Kirjastus: Routledge
  • ISBN-13: 9781317685562
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ISO 9001:2015 Audit ProceduresSuurem pilt
  • Formaat: 306 pages
  • Ilmumisaeg: 01-Jul-2016
  • Kirjastus: Routledge
  • ISBN-13: 9781317685562
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Fully revised, updated and expanded, this 4th Edition completes the trio by providing access to methods for auditing against the requirements of ISO 9001:2015.Although primarily aimed at showing how small businesses auditors can complete management reviews and internal, external and third party quality audits, this book will prove invaluable to professional auditors.Containing an overview of the changes made by the 2015 edition of ISO 9001 and how these will affect how audits need to be completed in future, the book also includes an extensive range of audit checklists, explanations and example questionnaires.For convenience, this book is divided into three parts, withPart 1 -describing the requirements of ISO 9001:2015Part 2 - providing background information for auditorsPart 3 containing a series of explanations, checklists and example questionnaires to assist auditors in compiling their own system and individual specific audit check sheets. These consist of:ISO 9001:2015 headings etc.ISO 9001:2015 – explanation and likely documentationISO 9001:2015 – organisational requirementsISO 9001:2015 – management requirementsISO 9001:2015 audit questionnaireAdditional (general purpose) audit checksStage audit check sheetComplete index for ISO 9001:2015ISO 9001:2015 crosscheck and correspondence formAudit check sheet formComparison between ISO 9001:2015 and ISO 9001:2008Counter-comparison between ISO 9001:2008 and ISO 9001:2015A selection of audit formsISO 9001:2015 – elements covered and outstandingAnd for assistance:Acronyms and abbreviations used in quality.Glossary of terms used in qualityReferencesUseful addresses.

Arvustused

Rays easy to read book ISO 9001:2015 Audit Procedures is a must have for small businesses wishing to complete management reviews and quality audits. This step by step guide includes forms, questionnaires and authors hints that are invaluable. - D.M. Belair, CAO, Kawartha Controls

'An invaluable resource I highly recommend. Easy to read, to the point explanations, detailed checklists and diagrams, this is the one book you need if you would like to understand ISO 9001:2015 audit procedures. Ray explains the ISO terminology, definitions and processes, and provides checklist questions that an auditor would be looking to answer. I would also recommend this book alongside Rays ISO 9001:2015 in Brief, as combined they give you all you need to know about the QM System and associated audit and certification processes.' - Jonathan Parkinson Plantastic DWC LLC. Dubai

About the author xi
Foreword xiii
Preface xv
PART 1 QUALITY MANAGEMENT OVERVIEW
1(124)
1 The background to ISO 9001:2015
3(26)
1.1 So what has changed?
5(1)
1.2 Background to the ISO revision process
6(1)
1.3 The revision process
6(1)
1.4 Annex SL
7(2)
1.5 What are the main changes to the new standard?
9(1)
1.6 Key changes
10(2)
1.7 ISO 9001:2015 clauses that have been changed, amended or deleted
12(6)
1.8 Top management
18(1)
1.9 The process model
19(6)
1.10 Benefits of the revised standard
25(1)
1.11 Other benefits
25(2)
1.12 Permissable exclusions
27(1)
1.13 Cost
27(2)
2 The content and requirements of the ISO 9001:2015 Standard
29(28)
2.1 What are the current ISO 9000 standards?
29(3)
2.2 What is the structure of ISO 9001:2008?
32(21)
2.3 What is the difference between ISO 9001:2015 and ISO 9001:2008?
53(4)
3 Compatibility of ISO 9001:2015 with other management systems
57(18)
3.1 Is ISO 9001:2015 compatible with other management systems?
57(4)
3.2 What other standards are based on ISO 9001:2008?
61(14)
4 Background reminders for auditors
75(50)
4.1 Purpose of an audit
78(1)
4.2 The basic audit process
78(2)
4.3 Types of audit
80(1)
4.4 Audit categories
80(11)
4.4.1 First party (internal) audit
81(10)
4.5 External audit
91(8)
4.6 Third party certification audits
99(3)
4.7 Conformity assessment
102(2)
4.8 Quality assurance during a product's or service's lifecycle
104(9)
4.9 What is the effect of ISO 9001:2015's new requirements on auditors?
113(12)
PART 2 ISO 9001:2015 CHECKLISTS
125(130)
Introduction
127(6)
2.1 ISO 9001:2015 -- Organisational responsibilities
133(3)
4 Context of the organisation
136(1)
4.1 Understanding the organisation and its context
136(1)
4.2 Understanding the needs and expectations of interested parties
136(1)
4.3 Determining the scope of the quality management system
136(1)
4.3.1 Quality management system and its processes
136(1)
5 Leadership
136(1)
5.7 Leadership and commitment
136(1)
5.2 Policy
137(1)
5.3 Organisation roles, responsibilities and authorities
137(1)
6 Planning
137(1)
6.1 Actions to address risks and opportunities
137(1)
6.2 Quality objectives and planning to achieve them
137(1)
6.3 Planning of changes
138(1)
7 Support
138(2)
7.7 Resources
138(1)
7.2 Competence
139(1)
7.3 Awareness
139(1)
7.4 Communication
139(1)
7.5 Documented information
139(1)
8 Operation
140(3)
8.1 Operational planning and control
140(1)
8.2 Requirements for products and services
140(1)
8.3 Design and development of products and services
141(1)
8.4 Control of externally provided processes, products and services
141(1)
8.5 Production and service provision
142(1)
8.6 Release of products and services
143(1)
8.7 Control of nonconforming outputs
143(1)
9 Performance evaluation
143(2)
9.1 Monitoring, measurement, analysis and evaluation
143(1)
9.2 Internal audit
144(1)
9.3 Management review
144(1)
10 Improvement
145(11)
70.7 General
145(1)
10.2 Nonconformity and corrective action
145(1)
10.3 Continual improvement
145(2)
2.2 ISO 9001:2015's Organisational Requirements
147(6)
2.2.1 Context of the organisation
148(1)
2.2.2 Leadership
148(1)
2.2.3 Planning
149(1)
2.2.4 Support
149(1)
2.2.5 Operation
150(2)
2.2.6 Performance evaluation
152(1)
2.2.7 Improvement
152(1)
2.3 A complete checklist against the requirements of ISO 9001:2015
153(3)
Introductory questions
156(1)
4 Context of the organisation
156(4)
4.1 Understanding the organisation and its context
156(1)
4.2 Understanding the needs and expectations of interested parties
157(1)
4.3 Determining the scope of the Quality Management System
157(1)
4.4 Quality Management System and its processes
158(2)
5 Leadership
160(6)
5.7 Leadership and commitment
162(1)
5.2 Policy
163(2)
5.3 Organisational roles, responsibilities and authorities
165(1)
6 Planning
166(2)
6.1 Actions to address risks and opportunities
166(1)
6.2 Quality objectives and planning to achieve them
167(1)
6.3 Planning of changes
168(1)
7 Support
168(10)
7.1 Resources
168(5)
7.2 Competence
173(1)
7.3 Awareness
174(1)
7.4 Communication
175(1)
7.5 Control of documented information
176(2)
8 Operation
178(18)
8.1 Operational planning and control
178(1)
8.2 Requirements for products and services
179(3)
8.3 Design and development of products and services
182(6)
8.4 Control of externally provided processes, products and services
188(2)
8.5 Production and service provision
190(5)
8.6 Release of products and services
195(1)
9 Performance evaluation
196(6)
9.1 Monitoring, measurement, analysis and evaluation
196(2)
9.2 Internal audit
198(1)
9.3 Management review
199(3)
10 Improvement
202(53)
10.1 General
202(1)
10.2 Nonconformity and corrective action
203(1)
10.3 Continual improvement
204(1)
2.4 Additional (general purpose) check sheets
205(30)
2.4.1 Quality Management System
207(1)
2.4.2 Documented information requirements
208(2)
2.4.3 Management commitment
210(1)
2.4.4 Customer focus
211(1)
2.4.5 Quality Policy
211(1)
2.4.6 Planning
212(1)
2.4.7 Responsibility, authority and communication
212(1)
2.4.8 Management review
213(1)
2.4.9 Provision of resources
214(1)
2.4.10 Human resources
214(1)
2.4.11 Infrastructure
215(1)
2.4.12 Work environment
216(1)
2.4.13 Planning and product realisation
216(2)
2.4.14 Customer-related processes
218(1)
2.4.15 Design and development
219(3)
2.4.16 Purchasing
222(1)
2.4.17 Production and service provision
223(4)
2.4.18 Control of monitoring and measuring devices
227(2)
2.4.19 Monitoring and measurement
229(1)
2.4.20 Auditing
230(1)
2.4.21 Control of nonconforming products and services
231(2)
2.4.22 Analysis of data
233(1)
2.4.23 Improvement
234(1)
2.5 Example stage audit checks
235(8)
2.5.1 Design stage
236(2)
2.5.2 Manufacturing or production stage
238(1)
2.5.3 Acceptance stage
239(1)
2.5.4 In-service stage
240(3)
2.6 Comparison between ISO 9001:2015 and ISO 9001:2008
243(4)
2.7 Counter-comparison between ISO 9001:2008 and ISO 9001:2015
247(4)
2.8 Comparison between the 2015 versions of ISO 14001 and ISO 9001
251(4)
Annex A 255(16)
Abbreviations and acronyms 271(2)
Reference standards for Quality Management Systems 273(2)
Glossary of terms used in Quality Management standards 275(6)
Books by the same author 281
Ray Tricker (MSc, IEng, FIET, FCMI, FCQI, FIRSE) is currently working as the Senior Management Consultant for Herne European Consultancy Ltd - a company specialising in offering organisations access to a range of highly skilled and specialist consultants to help these companies enhance their business performance.
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