ISO 9001:2015 Audit Procedures

Ray Tricker

• Publisher: Routledge
• Year: 2016
• ISBN:
  9781317685555
• Edition: 4
• Topic: Business
• Subtopic: Operations
• Index: Business

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.

Part 1 Quality Management overview

The first part of the book is intended to be used by auditors (qualified or unqualified, professional or amateur) as a reminder of what ISO 9001:2015 is all about and the need to meet its requirements for Quality Management.

It consists of four separate chapters, namely:

Chapter 1: The background to ISO 9001:2015: What clauses have been changed, amended or deleted.

Chapter 2: The content and requirements of the ISO 9001:2015 standard: Its structure and explanation of the requirements. The differences between the previous 2008 edition of the standard and the current one.

Chapter 3: Compatibility of ISO 9001:2015 with other management systems: An example of the similarity between this new Quality Management standard and that of Occupational Health and Safety (i.e. the OHSAS 18000 series) and the Environmental standard (i.e. the ISO 14000 series), together with details of other standards that are based on ISO 9001:2015.

Chapter 4: Background reminders for auditors: A brief overview of the purpose and types of audit and the effect of ISO 9001:2015’s new requirements for auditors.

Chapter 1 The background to ISO 9001:2015

DOI: 10.4324/9781315774817-1

CONTENTS

• 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
  • 1.7.1 Clause 3: Terms and definitions
  • 1.7.2 Clause 4: Context of the organisation
  • 1.7.3 Clause 4.3: Determining the scope of the Quality Management System
  • 1.7.4 Clause 4.4: Quality Management System and its processes
  • 1.7.5 Clause 5: Leadership
  • 1.7.6 Clause 6: Planning
  • 1.7.7 Clause 7: Support
  • 1.7.8 Clause 7.5: Documented information
  • 1.7.9 Clause 8: Operation
  • 1.7.10 Clause 8.2: Design and development of products and services
  • 1.7.11 Clause 8.4: Control of externally proved processes, products and services
  • 1.7.12 Clause 8.7: Control of nonconforming processes
  • 1.7.13 Clause 9: Performance evaluation
  • 1.7.14 Clause 10: Improvement
• 1.8 Top Management
• 1.9 The Process Model
• 1.10 Benefits of the Revised Standard
• 1.11 Other Benefits
  • 1.11.1 Customers
  • 1.11.2 People within the organisation
  • 1.11.3 Owners and investors
  • 1.11.4 Suppliers and partners
  • 1.11.5 Society
• 1.12 Permissible Exclusions
• 1.13 Cost

Following the publication of the minor amendment to ISO 9001 in 2008, ISO carried out extensive research in preparation for an updated edition of ISO 9001 aimed at developing a long-term strategic plan for ISO and increasing the alignment of ISO’s management system standards through the development of a common high-level structure, common definitions and some common text for all current and future management standards.

The main result of ISO’s research indicated that whilst there was still significant satisfaction with the 2008 version of the standard, most people considered that in order to keep ISO 9001 relevant and reflect changes in its environment a revision of the 2008 edition was appropriate and that this revised standard (among other things) should:

• remain generic, and relevant to all types and sizes and of organisation regardless of whether they were designers, manufacturers, suppliers or end users;
• maintain the current focus on effective process management to produce cost-effective and desirable end results;
• take account of changes in Quality Management Systems practices and technology since the last major revision in 2008;
• reflect changes in the increasingly complex, demanding and dynamic environments in which organisations operate;
• enhance compatibility and alignment with other ISO management system standards;
• facilitate effective organisational implementation and effective conformity assessment by first, second and third parties;
• use simplified language and writing styles to aid understanding and consistent interpretations of its requirements; but above all;
• provide a stable core set of requirements for the next 10 years or more.

Fig. 1.1 History of the ISO 9001 Standard

Quality used to be about making sure that products and services were right and with an emphasis on producing something that could be inspected against a specific dimension or criterion. The product was then considered acceptable, or had to be reworked to become acceptable, or had to be scrapped (which could be very expensive). When things went wrong it was usual to blame the craftsmen (e.g. designers, software engineers, construction engineers, etc., etc!).

1.1 So What has Changed?

In a nutshell, the revised standard has:

• Brought quality and continuous improvement into the heart of every business – ensuring that Quality Management is now completely integrated and aligned with the business strategies of a particular organization.
• Emphasised the importance of Leadership – ...