ISO 9001:2015 Audit Procedures

✍ Scribed by Ray Tricker

• Publisher: Routledge
• Year: 2016
• Tongue: English
• Leaves: 307
• Edition: 4
• Category: Library

✦ Synopsis

Revised and fully, ISO 9001:2015 Audit Procedures describes the methods for completing management reviews and quality audits and describes the changes made to the standards for 2015 and how they are likely to impact on your own audit procedures.

Now in its fourth edition, this text includes essential material on process models, generic processes and detailed coverage of auditor questionnaires. Part II includes a series of useful checklists to assist auditors in compiling their own systems and individual audit check sheets. The whole text is also supported with a glossary of terms as well as explanations of acronyms and abbreviations used in quality.

ISO 9001:2015 Audit Procedures is for auditors of small businesses looking to complete a quality audit review for the 2015 standards. This book will also prove invaluable to all professional auditors completing internal, external and third party audits.

✦ Table of Contents

Cover
Title
Copyright
Contents
About the author
Dedication
Foreword
Preface
PART 1: QUALITY MANAGEMENT OVERVIEW
1 The background to ISO 9001:2015
1.1 So what has changed?
1.2 Background to the ISO revision process
1.3 The revision process
1.4 Annex SL
1.5 What are the main changes to the new standard?
1.6 Key changes
1.7 ISO 9001:2015 clauses that have been changed, amended or deleted
1.8 Top management
1.9 The process model
1.10 Benefits of the revised standard
1.11 Other benefits
1.12 Permissable exclusions
1.13 Cost
2 The content and requirements of the ISO 9001:2015 Standard
2.1 What are the current ISO 9000 standards?
2.2 What is the structure of ISO 9001:2008?
2.3 What is the difference between ISO 9001:2015 and ISO 9001:2008?
3 Compatibility of ISO 9001:2015 with other management systems
3.1 Is ISO 9001:2015 compatible with other management systems?
3.2 What other standards are based on ISO 9001:2008?
4 Background reminders for auditors
4.1 Purpose of an audit
4.2 The basic audit process
4.3 Types of audit
4.4 Audit categories
4.4.1 First party (internal) audit
4.5 External audit
4.6 Third party certification audits
4.7 Conformity assessment
4.8 Quality assurance during a product’s or service’s lifecycle
4.9 What is the effect of ISO 9001:2015’s new requirements on auditors?
PART 2: ISO 9001:2015 CHECKLISTS
Introduction
2.1 ISO 9001:2015 – Organisational responsibilities
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
4.3.1 Quality management system and its processes
5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organisation 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 of changes
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
2.2 ISO 9001:2015’s Organisational Requirements
2.2.1 Context of the organisation
2.2.2 Leadership
2.2.3 Planning
2.2.4 Support
2.2.5 Operation
2.2.6 Performance evaluation
2.2.7 Improvement
2.3 A complete checklist against the requirements of ISO 9001:2015
Introductory questions
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 of changes
7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Control of 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
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
2.4 Additional (general purpose) check sheets
2.4.1 Quality Management System
2.4.2 Documented information requirements
2.4.3 Management commitment
2.4.4 Customer focus
2.4.5 Quality Policy
2.4.6 Planning
2.4.7 Responsibility, authority and communication
2.4.8 Management review
2.4.9 Provision of resources
2.4.10 Human resources
2.4.11 Infrastructure
2.4.12 Work environment
2.4.13 Planning and product realisation
2.4.14 Customer-related processes
2.4.15 Design and development
2.4.16 Purchasing
2.4.17 Production and service provision
2.4.18 Control of monitoring and measuring devices
2.4.19 Monitoring and measurement
2.4.20 Auditing
2.4.21 Control of nonconforming products and services
2.4.22 Analysis of data
2.4.23 Improvement
2.5 Example stage audit checks
2.5.1 Design stage
2.5.2 Manufacturing or production stage
2.5.3 Acceptance stage
2.5.4 In-service stage
2.6 Comparison between ISO 9001:2015 and ISO 9001:2008
2.7 Counter-comparison between ISO 9001:2008 and ISO 9001:2015
2.8 Comparison between the 2015 versions of ISO 14001 and ISO 9001
Annex A
Abbreviations and acronyms
Reference standards for Quality Management Systems
Glossary of terms used in Quality Management standards
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