ISO 9000 Quality Systems Handbook-updated for the ISO 9001: 2015 standard

Increasing the Quality of an Organization’s Outputs

David Hoyle

• Publisher: Routledge
• Year: 2017
• eBook ISBN: 9781317282273
• Topic: Business
• Subtopic: Business General
• Index: Business

Completely revised to align with ISO 9001:2015, this handbook has been the bible for users of ISO 9001 since 1994, helping organizations get certified and increase the quality of their outputs.

Whether you are an experienced professional, a novice, or a quality management student or researcher, this is a crucial addition to your bookshelf. The various ways in which requirements are interpreted and applied are discussed using published definitions, reasoned arguments and practical examples. Packed with insights into how the standard has been used, misused and misunderstood, ISO 9000 Quality Systems Handbook will help you to decide if ISO 9001 certification is right for your company and will gently guide you through the terminology, requirements and implementation of practices to enhance performance.

Matched to the revised structure of the 2015 standard, with clause numbers included for ease of reference, the book also includes:

• Graphics and text boxes to illustrate concepts, and points of contention;
• Explanations between the differences of the 2008 and 2015 versions of ISO 9001;
• Examples of misconceptions, inconsistencies and other anomalies;
• Solutions provided for manufacturing and service sectors.

This new edition includes substantially more guidance for students, instructors and managers in the service sector, as well as those working with small businesses.

Don't waste time trying to achieve certification without this tried and trusted guide to improving your business – let David Hoyle lead you towards a better way of thinking about quality and its management and see the difference it can make to your processes and profits!

Part 1
Introduction

Introduction to Part 1

Consider these two scenarios:

1. The organization already exists; it is delivering services and providing products and services to customers, but getting quite a few complaints so it’s becoming difficult to compete on quality. It is making a profit but not enough to invest for the future because the managers spend a lot of time firefighting instead of improving the efficiency and effectiveness of their processes. It’s doing what it can to comply with regulations but occasionally breaches employment laws and environmental legislation as it strives to balance competing objectives. No matter how many times problems are fixed, similar problems seem to arise again elsewhere, and often quick fixes lead to bigger problems much later.
2. The organization already exists; it is delivering services and providing products and services to customers and mostly receiving compliments, but competition is tough. It is making enough profit to invest for the future because its managers are proactive, putting a lot of effort into ensuring risks to success are mitigated. Thus, this organization doesn’t need to spend much time firefighting and can instead pursue opportunities for improving the efficiency and effectiveness of its processes. By striving to satisfy customers in a way that meets the needs of the other stakeholders, it has found it can balance competing objectives and has not had compliance issues of any significance. When problems arise, managers tend not to go for the quick fix, but spend time ensuring that actions to prevent their recurrence won’t have adverse consequences later.

These scenarios represent situations where both organizations are likely to obtain benefits from adopting ISO 9001:2015. In scenario A, the organization will gain a competitive advantage from a significant improvement in its performance and demonstrable capability, and in scenario B, the organization will gain a competitive advantage by demonstrable capability. Most organizations are likely to be positioned between these two extremes and will therefore benefit to varying degrees from adopting ISO 9001:2015. Creating a competitive advantage in quality should be a goal of top management, and perhaps the most widely recognized tool for doing this is ISO 9001. The standard can be used in ways that make your organization less competitive, which is why it is so important that you digest Part 1 of this book first before deciding on your course of action.

In Chapter 1 we put the ISO 9000 family of standards in context. We examine its purpose, scope, content and application and the process by which it was developed. We include some statistics on its use and summarize the expected outcomes of accredited certification.

In Chapter 2 we compare the 2008 and 2015 editions, highlighting the significant changes, the rationale for the change in structure, the new requirements and the withdrawal of some requirements that were introduced in the first version nearly 30 years ago.

In Chapter 3 we examine the many misconceptions about the ISO 9000 family of standards that have grown since its inception. There are many views about the value of ISO 9001 certification, some positive and some negative. It has certainly spawned an industry that has not delivered as much as it promised, and even with the release of the 2015 version there is still much to be done to improve the standards, improve the image, improve the associated infrastructure and improve organizational effectiveness.

1
Putting ISO 9001 in context

Introduction

There shall be standard measures of wine, ale, and corn (the London quarter), throughout the kingdom. There shall also be a standard width of dyed cloth, russet, and haberject,¹ namely two ells within the selvedges.² Weights are to be standardised similarly.

(Magna Carta, 1215)

In the 800th anniversary year of Magna Carta, the International Organization for Standardization publishes a major revision to its most popular standard, ISO 9001. As will be understood from the quotation, standards have been used for centuries – in fact standards for quality have been traced as far back as 11th century BCE in China’s Western Zhou Dynasty, but the notion of quality systems emerged after World War II when the industrial practices were still largely based on scientific management as defined by Frederick Winslow Taylor at the turn of the 20th century.

Box 1.1 Steve Jobs on quality

Customers don’t form their opinions on quality from marketing, they don’t form their opinions on quality from who won the Deming Award or who won the Baldridge Award. They form their opinions on quality from their own experience with the products or the services.

(Jobs, 1990)

Many people have started their journey towards ISO 9001 certification by reading the standard and trying to understand the requirements. They get so far and then call for help, but they often haven’t learnt enough to ask the right questions. The helper might assume that the person already knows they are looking at ISO 9001 and therefore may not spend the necessary time for them to understand what it is all about, what pitfalls may lie ahead and whether, indeed, they need to make this journey at all. This should become clear when you read this chapter.

When you encounter ISO 9001 for the first time, it may be in a conversation, on the Internet, in a leaflet or brochure from your local chamber of commerce or, as many have done, from a customer. If you are a busy manager you could be forgiven for either putting it out of your mind or getting someone else to look into it. But you know that as a manager you are either maintaining the status quo or changing it, and if you stay with the status quo for too long, your organization will go into decline. So, you need to know whether there is an issue with product or service quality and:

• What the issue is?
• Why it’s an issue?
• What it’s costing you?
• What you should do about it?
• What the impact of it will be?
• How much it will cost to improve performance so that these types of issues don’t recur?
• Where the resources are going to come from?
• When you need to act?
• What the alternatives are and their relative costs?
• What the consequences are of doing nothing?

In this chapter, we put ISO 9001 in context by explaining:

• What ISO 9001 is intended to do, making the link between ISO 9000 and the fundamental basis for trade
• The process by which international standards are developed and the roles of the various groups involved
• Reasons for using ISO 9001 – the interdependent duo of capability and confidence
• The scope of ISO 9001 and what it means
• Applicability of ISO 9001 – why it’s difficult to rule anything out
• Design or assessment standard – the users’ choice
• ISO 9001 and the free movement of goods and services
• Popularity of ISO 9001 certification – some facts, figures and trends
• What accredited certification means and doesn’t mean

What ISO 9001 is intended to do

Box 1.2 ISO 9000 in a nutshell

The standards were created to facilitate international trade.

Organizations use ISO 9001 to demonstrate their capability and in so doing give their customers confidence that they will satisfy their needs and expectations and are committed to continual improvement.

Customers use ISO 9001 to obtain an assurance of product and service quality that they can’t get simply by examining them.

All other standards in the ISO 9000 family address particular aspects of quality management.

Since the dawn of civilization, the survival of communities has depended on trade. As communities grow, they become more dependent on others providing goods and services they are unable to provide from their own resources. Trade continues to this day on the strength of the customer–supplier relationshi...

Table of contents

• Cover
• Title
• Copyright
• Dedication
• Contents
• Preface to the seventh edition
• PART 1 Introduction
• PART 2 Anatomy and use of the standards
• PART 3 Terminology
• PART 4 Context of the organization
• PART 5 Leadership
• PART 6 Planning
• PART 7 Support
• PART 8 Operation
• PART 9 Performance evaluation
• PART 10 Improvement
• Appendix A: Common acronyms
• Appendix B: Glossary of terms
• Bibliography
• Index