ISO 9001:2015. Audit Procedures. Fourth edition. Ray Tricker. Ö Routledge fl m Taylor & Francis Group LONDON AND NEW YORK

Transcription

1 ISO 9001:2015 Audit Procedures Fourth edition Ray Tricker Ö Routledge fl m Taylor & Francis Group LONDON AND NEW YORK

2 Contents About the author Foreword Preface xi xiii xv PART 1: QUALITY MANAGEMENT OVERVIEW 1 1 The background to ISO 9001: So what has changed? Background to the ISO revision process The revision process Annex SL What are the main changes to the new Standard? Key changes ISO 9001:2015 clauses that have been changed, amended or deleted Top management The process model ßenefits of the revised Standard Other benefits Permissable exclusions Cost 27 2 The content and requirements of the ISO 9001:2015 Standard What are the current ISO 9000 Standards? What is the structure of ISO 9001:2008? What is the difference between ISO 9001:2015 and ISO 9001:2008? 53

3 o Contents 3 Compatibility of ISO 9001:2015 with other Management systems Is ISO 9001:2015 compatible with other management systems? What other Standards are based on ISO 9001:2008? 61 4 Background reminders for audltors Purpose of an audit The basic audit process Types of audit Audit categories First party (internal) audit Externa! audit Third party certification audits Conformity assessment Quality assurance du ring a product's or service's lifecycle What is the effect of ISO 9001:2015's new requirements on auditors? 113 PART 2: ISO 9001:2015 CHECKLISTS 125 Introduction ISO 9001: Organisational responsibilities Context of the Organisation Understanding the Organisation and its context Understanding the needs and expectations of interested parties Determining the scope of the quality management system Quality management system and its processes Leadership Leadership and commitment Policy Organisation roles, responsibilities and authorities Flanning Actions to address risks and opportunities Quality objectives andplanning to achieve them Planning of changes Support Resources 7.2 Competence 13g 7.3 Awareness 13g

4 Contents ^ yjj ) 7.4 Communication Documented Information Operation Operational planning and control Requirements for products and services Design and development of products and services Control of externally provided processes, products and services Production and Service provision Release of products and services Control of nonconforming Outputs Performance evaluation Monitoring, measurement, analysis and evaluation Internal audit Management review Improvement General Nonconformity and corrective action Continual improvement ISO 9001:2015's Organisational Requirements Context of the Organisation Leadership Flanning Support Operation Performance evaluation Improvement A complete checklist against the requirements of ISO 9001: Introductory questions Context of the Organisation Understanding the Organisation and its context Understanding the needs and expectations of interested parties Determining the scope of the Quality Management System Quality Management System and its processes Leadership Leadership and commitment Policy Organisational roles, responsibilities and authorities 165

5 fdjf) Contents 6 Flanning Actions to address risks and opportunities Quality objectives and planning to achieve them Planning of changes Support Resources Competence Awareness Communication Control of documented'information Operation Operational planning and control Requirements for products and services Design and development of products and services Control of externally provided processes, products and services Production and Service provision Release of products and services Performance evaluation Monitoring, measurement, analysis and evaluation Internal audit Management review Improvement General Nonconformity and corrective action Continual improvement Additional (general purpose) check sheets Quality Management System Documented Information requirements Management commitment Customer focus Quality Policy Planning Responsibility, authority and communication Management review Provision of resources Human resources Infrastructure Work environment Planning and product realisation Customer-related processes Design and development Purchasing 222

6 Contents ( ix) Production and service provision Contra! of monitoring and measuring devices Monitoring and measurement Auditing Control of nonconforming products and services Analysis of data Improvement Example stage audit checks Design stage Manufacturing or production stage Acceptanee stage In-service stage Comparison between ISO 9001:2015 and ISO 9001: Counter-comparison between ISO 9001:2008 and ISO 9001: Comparison between the 2015 versions of ISO and ISO Annex A 255 Abbreviations and acronyms 271 Reference Standards for Quality Management Systems 273 Glossary of terms used in Quality Management Standards 275 Books by the same author 281