ISO 9001: 2000 In Brief

Bruce Sherring-Lucas

• Publisher: Routledge
• Year: 2005
• ISBN:
  9781136391149
• Edition: 2
• Topic: Business
• Subtopic: Business General
• Index: Business

A clear and comprehensive guide to quickly set up a cost-effective Quality Management System Revised and expanded, the new edition of this easy-to-understand guide provides practical information on how to set up a cost-effective ISO 9001: 2000 compliant Quality Management System. With comprehensive coverage of the meaning, history and requirements of the current ISO 9000 standard, the book explains how businesses can easily and efficiently satisfy customer requirements for quality control and quality assurance. Four years into the current version of ISO 9001, the new edition of this valuable book incorporates the hard-won experiences of working with the standard, together with direct, accessible and straightforward guidance that is proven to work. New material in this edition covers: • The Application of the Eight Principles of Management
• Audit Basics
• Compatibility with other Management Systems and Standards
• Comprehensive Summary of the ISO 9001: 2000 Requirements
• Continual Improvement Methods
• Guidance on the Six Mandatory Requirements for Written Procedures
• Process Improvement Tools - including Six-Sigma Techniques
• Process Metrics
• Setting of Quality Objectives
• The 21 Specific Requirements of Management
• The Application of Information Technology in Quality Management

1	WHAT IS QUALITY?

Why is the word ‘Quality’ (although an everyday word), often misused, misquoted and misunderstood? Probably this is because when most people talk about the quality of an object, or service, they are normally talking about its excellence, perfection or its value. In reality, of course, they should be talking about how much it meets its designed purpose and satisfies the original requirements.

Take for example a £50,000 Mercedes and a £15,000 Ford. It would be very unfair to suggest that the Mercedes is a better quality car simply because it costs more! Being realistic, both cars meet their predetermined quality requirements because they have been built to exacting standards and are, therefore, equally acceptable as ‘quality’ vehicles. It is simply that the design purpose and original quality requirements (i.e. the level of quality) differ.

So what exactly is meant by the word quality? There are many definitions but the most commonly accepted definition of quality is ‘The degree to which a set of inherent characteristics fulfils requirements’ (ISO 9000:2000).

In other words, quality is based upon customer satisfaction. So in the case of the Mercedes and the Ford, a purchaser of a Mercedes will be satisfied only if they get leather seats and cruise control, whereas the Ford driver is happy with crushed velour and a CD player. Their required level of quality differs but each is equally satisfied with their purchase. The characteristics of each car satisfy the customer’s requirements.

Consumers, however, are not just interested in the level of quality ‘intended’ by the designer, manufacturer or supplier, they are far more interested in the delivery of a product (i.e. hardware, software, service or processed material) which is consistently of the same quality. They also want an assurance that the product that they are buying truly meets the quality standard that was initially offered and/or recommended.

Figure 1.1 Definition of quality

Products of a consistent quality mean that repeat purchases are more likely; something which any car driver appreciates when considering whether to stay with a preferred make and model.

This consumer requirement has meant that manufacturers and suppliers (especially the larger organisations) have now had to pay far more attention to the quality of their product than was previously necessary. Organisations have had to set up proper Quality Management Systems in order to control and monitor all stages of the production process and they have had to provide proof to the potential customer that their product has the guaranteed – and in some cases certified – quality required by the customer. In other words, the manufacturer or supplier has had to work within a Quality Management System (see Figure 1.2 for details) to produce their product or deliver their service.

Unfortunately, with the current trend towards micro-miniaturisation and the use of advanced materials and technology, most modern day products have become extremely complex assemblies compared to those that were available just a few years ago. This has meant that many more people are now involved in the manufacture and/or supply of a relatively simple object and this has increased the likelihood of a production or design fault occurring.

Similarly, the responsibility for the quality of a product has also been spread over an increasing amount of people, which has meant that the manufacturer’s and/or supplier’s guarantee of quality has, unfortunately, become less precise.

The growing demand for an assurance of quality before a contract is awarded has reinforced the already accepted adage that quality products play an important role in securing new markets as well as retaining those markets that already exist. Without doubt, in these days of competitive world markets, quality assurance has never been more relevant. No longer can suppliers rely on their reputation alone!

Thus the drive towards quality-led production now means that today’s purchasers are not just expecting a quality product but are also demanding proof that an organisation is constantly capable of producing quality products or providing quality services. The provision of this proof is normally in the form of an independent third party certification and this is possibly the single most important requirement for a manufacturer, organisation or supplier.

Figure 1.2 Some of the questions answered by a Quality Management System

Up until a few years ago, however, there were no viable third party certification schemes available. But with an increased demand for quality assurance during all stages of the manufacturing processes, came the requirement for manufacturers to work to recognised standards, and this is why ISO 9000 was first introduced.

So in summary, ‘Quality’ is:

•  giving complete satisfaction to the customer;

•  a standard which can be accepted by both the supplier and the customer;

•  complying consistently to an agreed level of specification;

•  providing an acceptable product at an acceptable cost;

•  providing a product which is ‘fit for the purpose’;

•  the totality of features or characteristics of a product that bear on its ability to satisfy a given need.

Quality is not about:

•  complying with a specification (as it is possible that the specification may be wrong);

•  being the best (since achieving this ideal may be very costly and could exceed the price that the customer is prepared to pay);

•  only producing a product that is ‘fit for the purpose’ (as that purpose may be completely different to the customer’s actual needs).

Quality is all about customer satisfaction!

2	WHAT IS A QUALITY MANAGEMENT SYSTEM?

‘A management system to direct and control an organisation with regard to quality.’ (ISO 9000:2000)

Let’s get one thing straight from the start; a company controls its business through the application of a business management system, not as the standard suggests through a quality management system. So don’t get hung up on the word quality.

Consider if you will, ISO 9001:2000 sets the standard for a business management system which, if implemented correctly, will lead to products and services of a predetermined quality. These products and services will, in turn, satisfy the customer’s requirements and expectations.

A better title for ISO 9001:2000 would possibly be ‘A Standard for Business Management Systems’. Indeed, a number of companies that have implemented ISO 9001:2000 have deliberately avoided using the term ‘quality’, preferring instead to simply call their business activities a ‘management system’.

Having said that, for the purposes of this book, we will stick with the term Quality Management System, as it is ill advised to upset the International Standards Organisation!

A Quality Management System is the organisational structure of responsibilities, activities, resources and events that together provide procedures and methods of implementation to ensure the capability of an organisation to meet quality requirements.

A successful Quality Management System (QMS) relies on a variety of interactions and inputs within an organisation as indicated in Figure 2.1.

Figure 2.1 The ingredients of a Quality Management System

An organisation having a carefully structured QMS can achieve their ultimate goals for Quality Assurance (QA) and Quality Control (QC).

The first thing that ISO 9001:2000 requires is for an organisation to set up and fully document their position with regard to quality assurance. These documents comprise the QMS and describe the organisation’s capability for supplying products that will comply with laid down quality standards. The Quality Manual contains a general description of the organisation’s quality policy and provides specific details about the quality assurance and quality control within that organisation.

In order to be successful an organisation must be able to prove that they are capable of producing the product to the customer’s complete satisfaction so that it conforms exactly to the ...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Dedication
• Table of Contents
• About the Authors
• Foreword
• Preface
• Introduction
• 1 What is Quality?
• 2 What is a Quality Management System?
• 3 The history of Quality Standards
• 4 Who produces Quality Standards?
• 5 What is ISO 9000:2000?
• 6 How quality helps during a product’s life cycle
• 7 Who controls quality in an organisation?
• 8 What are the purchaser’s responsibilities?
• 9 What are the supplier’s responsibilities?
• 10 What to do once the QMS is established
• 11 Quality Management and computer technology
• Annex A – ISO 9001:2000 – A summary of requirements
• Abbreviations and acronyms
• References
• Glossary
• Useful addresses
• Index