ISO 9001:2015 In Brief

Cover
Title
Copyright
Dedication
Contents
About the author
Foreword
Preface
1 What is quality?
	1.1 But who is responsible for managing quality in an organisation?
	1.2 And so what is the difference between a product and a service?
	1.3 What about Quality Control and Quality Assurance?
		1.3.1 Quality Control
		1.3.2 Quality Assurance
2 What is a Quality Management System?
	2.1 What are the requirements of a Quality Management System?
	2.2 What are the costs and benefits of having a Quality Management System?
	2.3 What is a Quality Manual?
		2.3.1 What goes into a Quality Manual?
		2.3.2 What does each part of the Quality Manual do?
	2.4 What is a Quality Policy?
		2.4.1 Mission Statements
		2.4.2 Corporate policy statement
		2.4.3 Process-specific policies
		2.4.4 How to set quality objectives
		2.4.5 How to go about setting measurable objectives
		2.4.6 Fancy a RUMBA?
	2.5 What is a Quality Process?
		2.5.1 The process approach
		2.5.2 Core Business Process
		2.5.3 What types of Core Processes would a business require?
		2.5.4 Supporting processes
		2.5.5 Inter-relationship of process documentation
		2.5.6 The hierarchy of processes
	2.6 What is a Quality Plan?
		2.6.1 What should be covered by a Quality Plan?
		2.6.2 Management responsibility
		2.6.3 Contract review
		2.6.4 Design control
		2.6.5 Documentation
		2.6.6 Purchasing
		2.6.7 Customer-supplied products and services
		2.6.8 Product and service identification and traceability
		2.6.9 Process control
		2.6.10 Inspection and testing
		2.6.11 Inspection, measuring and test equipment
		2.6.12 Nonconforming products and services
		2.6.13 Other considerations
	2.7 What is a Quality Procedure?
		2.7.1 What is the best way to write a Quality Procedure?
		2.7.2 What should go into a Quality Procedure?
	2.8 What is a Work Instruction?
		2.8.1 What should go into a Work Instruction?
		2.8.2 How many Work Instructions can I have?
	2.9 Who controls quality in an organisation?
		2.9.1 Who has overall responsibility?
		2.9.2 Management responsibilities
		2.9.3 The Quality Management Team
		2.9.4 The Staff
	2.10 How quality helps during the life cycle of products and services
		2.10.1 Design stage
		2.10.2 Manufacturing stage
		2.10.3 Acceptance stage
		2.10.4 In-service stage
		2.10.5 End-of-life stage
	2.11 What are the purchaser’s responsibilities?
	2.12 What are the supplier’s responsibilities?
	2.13 Quality Management and computer technology
3 The history of quality standards
	3.1 1979 – BS 5750:1979 Parts 1, 2 and 3
	3.2 1981–1986
	3.3 1987 – ISO 9000:1987 Parts 1, 2 and 3
	3.4 1994 – BS EN ISO 9000:1994
	3.5 2000 – ISO 9001:2000
	3.6 2008 – ISO 9001:2008
	3.7 2015 – ISO 9001:2015
	3.8 So what has changed?
4 Who produces quality standards?
	4.1 Who and what is ISO?
	4.2 Who and what is the IEC?
	4.3 Who and what is the ITU?
	4.4 How important is the work of all these committees?
	4.5 Military standards
	4.6 National standards
5 A brief summary of ISO 9001:2015
	5.1 Background reminder
	5.2 Why has ISO 9001 been revised?
	5.3 How are these standards revised?
	5.4 What effect did this revision have on ISO 9001?
		5.4.1 Other changes
	5.5 What is Annex SL?
		5.5.1 What is the new structure of Annex SL?
		5.5.2 What is the current status of Annex SL revisions?
	5.6 But what exactly is meant by the ‘ISO 9000 family of standards’?
		5.6.1 ISO 9000:2015 Quality Management Systems: Fundamentals and vocabulary
		5.6.2 ISO 9004:2009 Managing for the sustained success of an organisation. A quality management approach
		5.6.3 ISO 9001:2008 Quality Management Systems: Requirements
	5.7 The seven principles of management
		5.7.1 The Process Model
	5.8 What is the new structure of ISO 9001?
	5.9 What are the major clause changes seen in ISO 9001:2015?
		5.9.1 Are there any other significant changes?
		5.9.2 What about the revised duties of Top Management?
6 What other standards are based on ISO 9001:2015?
	6.1 Aerospace
	6.2 Auditing management systems
	6.3 Automotive industry
	6.4 Computer software
	6.5 Crop production
	6.6 Data
	6.7 Education
	6.8 Electoral organisations
	6.9 Energy management systems
	6.10 Explosive atmospheres
	6.11 Food safety
	6.12 Good manufacturing practice
	6.13 Health care
	6.14 Human resources
	6.15 Information technology
	6.16 Information security
	6.17 Local government
	6.18 Measurement manufacturing systems
	6.19 Medical devices
	6.20 Multi-layer piping systems
	6.21 Packaging: transport packages for dangerous products
	6.22 Petroleum, petrochemical and natural gas industries
	6.23 Quality Management System consultants
	6.24 Quality Management Systems projects
	6.25 Quality Plans
	6.26 Ships and marine technology
	6.27 Software engineering
	6.28 Space systems
	6.29 Supply chain management
	6.30 Systems engineering
	6.31 Telecommunications industry
	6.32 Testing and calibration laboratories
	6.33 Welding consumables
7 What to do once your QMS is established
	7.1 Internal audits
	7.2 Certification
		7.2.1 What are the benefits of achieving certification to ISO 9001:2015?
		7.2.2 What are the differences in being a certified, accredited and/or registered ISO 9001:2015 organisation?
		7.2.3 But can’t I just work ‘in compliance’ with ISO 9001?
		7.2.4 OK, so how do I become an ISO 9001-registered organisation then?
		7.2.5 What would the budgetary costs be for doing all this?
		7.2.6 How long will it take to become certified?
		7.2.7 What is the certification process?
	7.3 What to do once my QMS is established
		7.3.1 Improvement
		7.3.2 Process metrics
		7.3.3 Process improvement tools
		7.3.4 How do I apply Six Sigma to improve my processes?
		7.3.5 Why have six Sigmas when one would do?
	7.4 How do I upgrade my existing ISO 9001:2008 registration to meet ISO 9001:2015’s requirements?
		7.4.1 Does my organisation have to scrap its existing processes and procedures and start again?
		7.4.2 Does my organisation need to re-certify now that ISO 9001:2015 is published?
		7.4.3 How can I prepare for the new standard?
	7.5 How can all this be achieved?
Annex A – ISO 9001:2015 – a summary of requirements
Abbreviations and acronyms
Reference standards for Quality Management Systems
Glossary of terms used in Quality Management standards
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