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E-raamat: ISO 9001:2015 for Small Businesses

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(Herne European Consultancy Ltd, UK)
  • Formaat: 678 pages
  • Ilmumisaeg: 04-Oct-2016
  • Kirjastus: Routledge
  • ISBN-13: 9781317685685
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ISO 9001:2015 for Small BusinessesSuurem pilt
  • Formaat: 678 pages
  • Ilmumisaeg: 04-Oct-2016
  • Kirjastus: Routledge
  • ISBN-13: 9781317685685
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The new edition of this top selling quality management book includes down to earth explanations aimed at helping you to understand what the new standard is all about and to determine what you need to work in compliance with and/or achieve certification to ISO 9001:2015. It covers all the major changes to this revised ISO standard and how they will affect your work, along with direct, accessible and straightforward guidance that has always been part of this series.As a bonus, this book also contains a free, customisable example of a complete, generic, Quality Management System that can be adapted to suit any organization, large or small.ISO 9001:2015 for Small Businesses consists of a number of Chapters covering topics such as:What is the importance of quality to small businesses - A reminder of the requirements and benefits of quality, quality control and quality assuranceWhat is the background to ISO 9000 – A brief historical record of how quality management standards began, their interoperability and the basic requirements of ISO 9001:2015 are explained.What is a process approach - The background to, and the inter-relationship of, processes as recommended by ISO 9001:2015.What is a Quality Management System? - The basic requirements of a quality management system and how a quality management system can be structured to any organisation’s particular type of business.What is the structure of ISO 9001:2015? – The requirements and recommendations of ISO 9001:2015 are explained and an indication of the documented proof that an organization needs to obtain, in order to show compliance with the standard, is provided.Chapter 6 - A fully worked example of an auditable, ISO 9001:2015 compliant, quality management systemSelf-Assessment – Covering the often-overlooked topic of self-assessment and methods for completing management reviews, internal, external as well as third-party audits and evaluations.What are the costs involved in an organization obtaining Registration to this Standard? – An indication of the easiest and most cost effective method of becoming an ISO 9001:2015 Certified Organization.This is supported by:Bibliography – Containing: Abbreviations and Acronyms; Reference Standards for Quality Management Systems; Glossary of terms used in quality management standards; and of course!) ‘Books by the same Author’.Full Index

Arvustused

Rays practical and easy to use book is full of helpful illustrations, hints, advice and a fully customizable example Quality Management System. This guide saves the small business owner valuable time and money. Excellent! - D.M. Belair, CAO, Kawartha Controls

There are many ISO 9001:2015 books out there but this book by Ray is the one for quick, simple and to the point explanations that a non ISO specialist can understand and implement. Even better is the fact that this book is generic and there are forms and templates that you can download to enable you to create the entire ISO 9001:2015 Quality Management System yourself, no matter what business youre in. This book is invaluable in helping you understand and create all aspects of the ISO 9001 QMS. I have absolutely no hesitation in recommending this book for any business or person wanting to take up the challenge to understand and create their own ISO 9001:2015 QMS. - Szilvia Parkinson, Plantastic Rail UK Ltd.

Foreword xiii
Preface xv
About the author xxvii
1 What is the importance of quality to small businesses?
1(24)
1.1 Why manage quality?
1(1)
1.2 The importance of quality
2(1)
1.3 Quality -- the fundamentals
3(2)
1.4 Quality Control
5(1)
1.5 Quality Assurance
6(1)
1.6 Specifications
7(6)
1.6.1 The significance of specifications
8(1)
1.6.2 Types of specification
8(2)
1.6.3 Supplier's responsibilities
10(1)
1.6.4 Purchaser's responsibilities
11(2)
1.7 Quality Assurance during a product's life cycle
13(6)
1.7.1 Design stage
14(2)
1.7.2 Production stage
16(1)
1.7.3 Acceptance stage
16(1)
1.7.4 In-service stage
17(2)
1.8 Benefits and costs of Quality Assurance
19(2)
1.9 Costs of quality failure
21(1)
1.9.1 The supplier
21(1)
1.9.2 The purchaser
22(1)
1.10 What are the costs involved in an organisation obtaining registration to this standard?
22(3)
2 What is the background to ISO 9000?
25(70)
2.1 What is ISO 9000?
25(2)
2.2 What national and international standards are available (and what is their interoperability)?
27(5)
2.3 What about the growth of quality-specific standards?
32(2)
2.4 But who are ISO?
34(1)
2.5 What is the background to ISO 9000 and its current status?
35(8)
2.5.1 ISO 9000:1987
36(1)
2.5.2 ISO 9000:1994
36(2)
2.5.3 ISO 9001:2000
38(3)
2.5.4 ISO 9001:2008
41(1)
2.5.5 ISO 9001:2015
41(2)
2.6 So what has changed?
43(2)
2.7 What is Annex SL?
45(2)
2.8 What will ISO's core cases be in the future?
47(1)
2.9 What is the new structure of Annex SL?
47(4)
2.10 What is the current status of Annex SL revisions?
51(1)
2.11 What are the current ISO 9000 standards?
52(3)
2.11.1 ISO 9000:2015 Quality Management Systems -fundamentals and vocabulary
53(1)
2.11.2 ISO 9004:2009 Managing for the sustained success of an organisation: a Quality Management approach
53(1)
2.11.3 ISO 9001:2015 Quality Management Systems -requirements
54(1)
2.12 Quality Management Principles
55(4)
2.13 Impact of the changes
59(1)
2.14 ISO 9001:2015's compatibility with other management systems
60(3)
2.14.1 The OHSAS 18000 Series
61(1)
2.14.2 The ISO 14000 Series
62(1)
2.14.3 What is the difference between ISO 9000 and ISO 14000?
63(1)
2.15 What other standards are based on ISO 9001:2015?
63(8)
2.15.1 Aerospace
66(1)
2.15.2 Auditing management systems
66(1)
2.15.3 Automotive industry
66(1)
2.15.4 Computer software
66(1)
2.15.5 Crop production
66(1)
2.15.6 Data
67(1)
2.15.7 Education
67(1)
2.15.8 Electoral organisations
67(1)
2.15.9 Energy management systems
67(1)
2.15.10 Explosive atmospheres
67(1)
2.15.11 Food safety
67(1)
2.15.12 Good manufacturing practice
68(1)
2.15.13 Healthcare
68(1)
2.15.14 Human resources
68(1)
2.15.15 Information security
68(1)
2.15.16 Information technology
68(1)
2.15.17 Local government
68(1)
2.15.18 Measurement manufacturing systems
69(1)
2.15.19 Medical devices
69(1)
2.15.20 Multilayer piping systems
69(1)
2.15.21 Packaging -- transport packages (or dangerous products
69(1)
2.15.22 Petroleum, petrochemical and natural gas industries
69(1)
2.15.23 Quality Management System consultants
70(1)
2.15.24 Quality Management Systems projects
70(1)
2.15.25 Quality plans
70(1)
2.15.26 Ships and marine technology
70(1)
2.15.27 Software engineering
70(1)
2.15.28 Space systems
70(1)
2.15.29 Supply chain management
71(1)
2.15.30 Systems engineering
71(1)
2.15.31 Telecommunications industry
71(1)
2.15.32 Testing and calibration laboratories
71(1)
2.15.33 Welding consumables
71(1)
2.16 What is ISO 9001:2015's basic process?
71(3)
2.17 What is the new structure of ISO 9001:2015?
74(10)
2.18 What about auditing ISO 9001:2015?
84(3)
2.18.1 Purpose of an audit
84(1)
2.18.2 Types of audit
85(1)
2.18.3 Audit categories
85(1)
2.18.4 ISO 19011:2011
86(1)
2.19 Certification
87(2)
2.19.1 Who can certify an organisation?
87(1)
2.19.2 What is required for certification?
88(1)
2.19.3 What is the difference between being certified and being registered?
88(1)
2.19.4 What is the difference between being certified and being compliant?
88(1)
2.19.5 What is the difference between being certified and being accredited?
89(1)
2.20 Who will be responsible for quality within an organisation?
89(1)
2.21 What is the future evolution of ISO 9000?
90(5)
Annex A Comparison between the ISO 9001:2015 and ISO 14001:2015 standards
91(4)
3 The process approach
95(20)
3.1 Background
95(4)
3.1.1 Example of a simple process flow chart
98(1)
3.2 But what is the process approach?
99(4)
3.3 Planning an organisation's business processes
103(4)
3.3.1 Core business process
105(2)
3.4 What kind of core processes would a business require?
107(4)
3.4.1 Supporting processes
108(2)
3.4.2 Primary supporting processes
110(1)
3.4.3 Secondary supporting processes
111(1)
3.5 Inter-relationship of process documentation
111(3)
3.6 The hierarchy of processes
114(1)
4 What is a Quality Management System?
115(24)
4.1 Quality Management System -- requirements
115(2)
4.1.1 Basic requirements of a Quality Management System
115(2)
4.2 Quality Management System -- principles
117(4)
4.3 Quality Management System -- approach
121(1)
4.4 Quality Management System -- structure
122(2)
4.4.1 QMS documentation
122(2)
4.5 Quality policy
124(1)
4.5.7 Corporate policy statement
125(1)
4.6 Processes
125(1)
4.7 Quality procedures
126(1)
4.7.1 What documented procedures are required by ISO 9001:2015?
127(1)
4.8 Work instructions
127(1)
4.8.7 What is the difference between a work instruction and a record?
128(1)
4.9 Quality plan
128(7)
4.9.7 Management responsibility
131(1)
4.9.2 Contract review
131(1)
4.9.3 Design control
131(1)
4.9.4 Document and data control
132(1)
4.9.5 Purchasing
133(1)
4.9.6 Customer supplied products and services
133(1)
4.9.7 Identification and traceability
133(1)
4.9.8 Process control
133(1)
4.9.9 Inspection and testing
134(1)
4.9.10 Inspection, measuring and test equipment
134(1)
4.9.11 Nonconforming products and services
134(1)
4.9.12 Other considerations
134(1)
4.10 Documented information
135(4)
5 The structure of ISO 9001:2015
139(100)
1 Scope
141(1)
2 Normative references
142(1)
3 Terms and definitions
142(1)
4 Context of the organisation
143(5)
4.7 Understanding the organisation and its context
143(1)
4.2 Understanding the needs and expectations of interested parties
144(1)
4.3 Determining the scope of the Quality Management System
145(2)
4.4 Quality Management System and its processes
147(1)
5 Leadership
148(8)
5.1 Leadership and commitment
149(3)
5.2 Policy
152(3)
5.3 Organisational roles, responsibilities and authorities
155(1)
6 Planning
156(7)
6.1 Actions to address risks and opportunities
157(3)
6.2 Quality objectives and planning to achieve them
160(2)
6.3 Planning
162(1)
7 Support
163(16)
7.1 Resources
163(8)
7.2 Competence
171(1)
7.3 Awareness
172(1)
7.4 Communication
173(1)
7.5 Documented information
173(6)
8 Operation
179(38)
8.1 Operational planning and control
179(2)
8.2 Requirements for products and services
181(4)
8.3 Design and development of products and services
185(13)
8.4 Control of externally provided processes, products and services
198(7)
8.5 Production and service provision
205(7)
8.6 Release of products and services
212(2)
8.7 Control of nonconforming outputs
214(3)
9 Performance evaluation
217(13)
9.7 Monitoring, measurement, analysis and evaluation
218(5)
9.2 Internal audit
223(3)
9.3 Management review
226(4)
10 Improvement
230(9)
10.1 General
230(1)
10.2 Nonconformity and corrective action
231(5)
10.3 Continual improvement
236(3)
6 Example Quality Management System
239(340)
7 Self-assessment
579(26)
7.1 How ISO 9000 can be used to check small businesses' Quality Management Systems
580(1)
7.2 Internal audit
580(11)
7.2.1 Audit plan
582(2)
7.2.2 Internal audit programme
584(7)
7.3 External audit
591(4)
7.3.1 Supplier evaluation
591(4)
7.4 The surveillance or quality audit visit
595(2)
7.4.1 Multiple evaluations and audits
596(1)
7.4.2 Secondary audit
596(1)
7.4.3 Third-party evaluation
596(1)
7.4.4 Conformity assessment
596(1)
7.5 Self-assessment checklists
597(2)
7.5.1 Documentation required by an organisation to meet ISO 9001:2015 requirements
597(1)
7.5.2 ISO 9001:2015 requirements of management
597(1)
7.5.3 Example checklists of typical auditors' questions for ISO 9001:2015 compliance
598(1)
7.5.4 Example internal stage audit checklists
598(1)
7.6 Documentation requirements
599(6)
7.6.1 The requirements
599(3)
7.6.2 Control of documents
602(2)
7.6.3 Software programs for document control
604(1)
8 What are the costs involved in an organisation obtaining registration to this standard?
605(16)
8.1 Can I just work `incompliance' with ISO 9001?
606(1)
8.2 So why should I bother about getting ISO 9001 certification?
606(1)
8.3 But what is the difference to being a certified, accredited and/or a registered ISO 9001:2015 organisation?
607(1)
8.4 But is it worth the cost and trouble to become ISO 9001:2015 certified?
607(1)
8.5 What are the benefits of ISO international standards?
608(1)
8.6 How do I become an ISO 9001 registered organisation?
609(2)
8.7 How long will it take to become certified?
611(1)
8.8 How is the certification completed?
612(1)
8.9 What happens during the actual ISO 9001 audit?!
612(1)
8.10 What other national certification bodies are there?
613(2)
8.11 What happens after certification and beyond?
615(1)
8.12 How can I maintain my certification?
615(1)
8.13 What are the advantages of maintaining my ISO 9001:2015 certification?
615(6)
Abbreviations and acronyms 621(4)
Reference standards for Quality Management Systems 625(2)
Glossary of terms used In Quality Management standards 627(6)
Books by the author 633(6)
Index 639
Ray Tricker (MSc, IEng, CQP-FCQI, FIET, FCMI, 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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