ISO 9001:2015 for Small Businesses

Description

Small businesses face many challenges today, including the increasing demand by larger companies for ISO 9001compliance, a challenging task for any organisation and in particular for a small business without quality assurance experts on its payroll. Ray Tricker has already guided hundreds of businesses through to ISO accreditation, and this sixth edition of his life-saving ISO guide provides all you need to meet the new 2015 standards. ISO 9001:2015 for Small Businesses helps you understand what the new standard is all about and how to achieve compliance in a cost effective way. Covering all the major changes to the standards, this book provides direct, accessible and straightforward guidance. Cover Half Title Title Page Copyright Page Dedication Table of Contents Foreword Preface About the author 1 What is the importance of quality to small businesses? 1.1 Why manage quality? 1.2 The importance of quality 1.3 Quality – the fundamentals 1.4 Quality Control 1.5 Quality Assurance 1.6 Specifications 1.6.1 The significance of specifications 1.6.2 Types of specification 1.6.3 Supplier’s responsibilities 1.6.4 Purchaser’s responsibilities 1.7 Quality Assurance during a product’s life cycle 1.7.1 Design stage 1.7.2 Production stage 1.7.3 Acceptance stage 1.7.4 In-service stage 1.8 Benefits and costs of Quality Assurance 1.9 Costs of quality failure 1.9.1 The supplier 1.9.2 The purchaser 1.10 What are the costs involved in an organisation obtaining registration to this standard? 2 What is the background to ISO 9000? 2.1 What is ISO 9000? 2.2 What national and international standards are available (and what is their interoperability)? 2.3 What about the growth of quality-specific standards? 2.4 But who are ISO? 2.5 What is the background to ISO 9000 and its current status? 2.5.1 ISO 9000:1987 2.5.2 ISO 9000:1994 2.5.3 ISO 9001:2000 2.5.4 ISO 9001:2008 2.5.5 ISO 9001:2015 2.6 So what has changed? 2.7 What is Annex SL? 2.8 What will ISO’s core cases be in the future? 2.9 What is the new structure of Annex SL? 2.10 What is the current status of Annex SL revisions? 2.11 What are the current ISO 9000 standards? 2.11.1 ISO 9000:2015 Quality Management Systems – fundamentals and vocabulary 2.11.2 ISO 9004:2009 Managing for the sustained success of an organisation: a Quality Management approach 2.11.3 ISO 9001:2015 Quality Management Systems – requirements 2.12 Quality Management Principles 2.13 Impact of the changes 2.14 ISO 9001:2015’s compatibility with other management systems 2.14.1 The OHSAS 18000 Series 2.14.2 The ISO 14000 Series 2.14.3 What is the difference between ISO 9000 and ISO 14000? 2.15 What other standards are based on ISO 9001:2015? 2.15.1 Aerospace 2.15.2 Auditing management systems 2.15.3 Automotive industry 2.15.4 Computer software 2.15.5 Crop production 2.15.6 Data 2.15.7 Education 2.15.8 Electoral organisations 2.15.9 Energy management systems 2.15.10 Explosive atmospheres 2.15.11 Food safety 2.15.12 Good manufacturing practice 2.15.13 Health care 2.15.14 Human resources 2.15.15 Information security 2.15.16 Information technology 2.15.17 Local government 2.15.18 Measurement manufacturing systems 2.15.19 Medical devices 2.15.20 Multilayer piping systems 2.15.21 Packaging – transport packages for dangerous products 2.15.22 Petroleum, petrochemical and natural gas industries 2.15.23 Quality Management System consultants 2.15.24 Quality Management Systems projects 2.15.25 Quality plans 2.15.26 Ships and marine technology 2.15.27 Software engineering 2.15.28 Space systems 2.15.29 Supply chain management 2.15.30 Systems engineering 2.15.31 Telecommunications industry 2.15.32 Testing and calibration laboratories 2.15.33 Welding consumables 2.16 What is ISO 9001:2015’s basic process? 2.17 What is the new structure of ISO 9001:2015? 2.18 What about auditing ISO 9001:2015? 2.18.1 Purpose of an audit 2.18.2 Types of audit 2.18.3 Audit categories 2.18.4 ISO 19011:2011 2.19 Certification 2.19.1 Who can certify an organisation? 2.19.2 What is required for certification? 2.19.3 What is the difference between being certified and being registered? 2.19.4 What is the difference between being certified and being compliant? 2.19.5 What is the difference between being certified and being accredited? 2.20 Who will be responsible for quality within an organisation? 2.21 What is the future evolution of ISO 9000? Annex A Comparison between the ISO 9001:2015 and ISO 14001:2015 standards 3 The process approach 3.1 Background 3.1.1 Example of a simple process flow chart 3.2 But what is the process approach? 3.3 Planning an organisation’s business processes 3.3.1 Core business process 3.4 What kind of core processes would a business require? 3.4.1 Supporting processes 3.4.2 Primary supporting processes 3.4.3 Secondary supporting processes 3.5 Inter-relationship of process documentation 3.6 The hierarchy of processes 4 What is a Quality Management System? 4.1 Quality Management System – requirements 4.1.1 Basic requirements of a Quality Management System 4.2 Quality Management System – principles 4.3 Quality Management System – approach 4.4 Quality Management System – structure 4.4.1 QMS documentation 4.5 Quality policy 4.5.1 Corporate policy statement 4.6 Processes 4.7 Quality procedures 4.7.1 What documented procedures are required by ISO 9001:2015? 4.8 Work instructions 4.8.1 What is the difference between a work instruction and a record? 4.9 Quality plan 4.9.1 Management responsibility 4.9.2 Contract review 4.9.3 Design control 4.9.4 Document and data control 4.9.5 Purchasing 4.9.6 Customer supplied products and services 4.9.7 Identification and traceability 4.9.8 Process control 4.9.9 Inspection and testing 4.9.10 Inspection, measuring and test equipment 4.9.11 Nonconforming products and services 4.9.12 Other considerations 4.10 Documented information 5 The structure of ISO 9001:2015 1 Scope 2 Normative references 3 Terms and definitions 4 Context of the organisation 4.1 Understanding the organisation and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the Quality Management System 4.4 Quality Management System and its processes 5 Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities 6 Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning 7 Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 6 Example Quality Management System 7 Self-assessment 7.1 How ISO 9000 can be used to check small businesses’ Quality Management Systems 7.2 Internal audit 7.2.1 Audit plan 7.2.2 Internal audit programme 7.3 External audit 7.3.1 Supplier evaluation 7.4 The surveillance or quality audit visit 7.4.1 Multiple evaluations and audits 7.4.2 Secondary audit 7.4.3 Third-party evaluation 7.4.4 Conformity assessment 7.5 Self-assessment checklists 7.5.1 Documentation required by an organisation to meet ISO 9001:2015 requirements 7.5.2 ISO 9001:2015 requirements of management 7.5.3 Example checklists of typical auditors’ questions for ISO 9001:2015 compliance 7.5.4 Example internal stage audit checklists 7.6 Documentation requirements 7.6.1 The requirements 7.6.2 Control of documents 7.6.3 Software programs for document control 8 What are the costs involved in an organisation obtaining registration to this standard? 8.1 Can I just work ‘in compliance’ with ISO 9001? 8.2 So why should I bother about getting ISO 9001 certification? 8.3 But what is the difference to being a certified, accredited and/or a registered ISO 9001:2015 organisation? 8.4 But is it worth the cost and trouble to become ISO 9001:2015 certified? 8.5 What are the benefits of ISO international standards? 8.6 How do I become an ISO 9001 registered organisation? 8.7 How long will it take to become certified? 8.8 How is the certification completed? 8.9 What happens during the actual ISO 9001 audit?! 8.10 What other national certification bodies are there? 8.11 What happens after certification and beyond? 8.12 How can I maintain my certification? 8.13 What are the advantages of maintaining my ISO 9001:2015 certification? Abbreviations and acronyms Reference standards for Quality Management Systems Glossary of terms used In Quality Management standards Books by the author Index