Contents
Preface vii
1. Sustaining business 1
1.1 Introduction 1
1.2 Recession 2
1.3 Business sustainability 4
1.4 Evolution of QMS 4
1.5 Definition of quality 6
1.6 Imperatives of quality 8
1.7 Quality from a larger perspective 11
2. Understanding and implementation of ISO 9001:2008 14
2.1 Introduction 14
2.2 Fifty Steps for implementation 17
2.3 Undergo audits 46
2.4 Post-certification audits 47
2.5 Points to remember 48
3. Roles and responsibilities of management representative 49
3.1 Who should be the management representative? 49
3.2 Jobs expected from management representative 51
3.3 Tips for management representative 55
4. Internal quality audits: A strong tool for quality management 56
4.1 Need for audits 56
4.2 Internal quality audits 58
4.3 Quality control versus quality audits 58
4.4 Product audit versus system audit 60
4.5 Top management review versus quality audits 60
4.6 Types of internal quality audits 61
4.7 Pre-requirements of an auditor 62
4.8 What is to be verified? 64
4.9 Can we discontinue quality control investigation? 79
4.10 Process audits 80
4.11 Imperatives of effective audit 83
4.12 Linking exercises – a strong tool for quality auditing 85
5. Measuring maturity in QMS implementation 95
5.1 Need for measurement 95
5.2 Measuring maturity by linking to the principles 96
5.3 Measuring maturity by considering the clauses 97
5.4 Guidelines for assessing maturity in QMS implementation 98
6. Welcome the complaints 133
6.1 Who is interested in complaining? 133
6.2 When customer complains? 134
6.3 When customer does not complain? 135
6.4 Customer – a free consultant 136
7. Face the audits 138
7.1 Why to face audits? 138
7.2 Basic human nature 140
7.3 What shall be audited? 140
7.4 Preparing for the audit 141
7.5 Face the audits 142
7.6 Role of a guide 143
7.7 Understand the non-conformities and observations 143
Appendix – 1: Departmental objectives and expectations 146
References 157
Index 158
Preface
To survive on this earth, it is necessary to keep ourselves fit. It might be an individual or an organization. One need to follow certain disciplines to keep his body fit; similarly, an organization also has to follow certain basic disciplines. The concepts of ISO 9001 give guidelines for helping an organization to remain fit all the time. What is needed is to implement it whole heartedly. Remember, one has to do his exercises and follow the diet to remain fit. This cannot be delegated to others.
It is unfortunate that the need for implementation of ISO 9001 was understood in a wrong way by majority of the people, and they consider it as a mere certification process to get entry to world markets. The concentration is on getting the certificate. The organizations somehow manage to convince the certifying body and get certificate with out even understanding the basic concepts. As the number of ISO 9001 certified organizations are increasing, the respect for the systems is coming down. When all are ISO 9001, there is no value for the same. There is a need to measure the level of implementation or the maturity of implementation.
In my experience of implementing ISO 9001 for last 18 years, I have seen different types of managements and the people. There are very few, who have understood the real essence of the systems and implementing them by heart. They are building a good foundation for their organization to remain stable for long. However, majority of the companies I visited are concentrating mainly on getting the certificate, somehow manage the audits and keep auditors happy. The managements are not taking interest and getting themselves involved in the internal quality audits. They blame that ISO is increasing their work, adding the paper work and bureaucracy and not helping improvement. People quote different quality systems like 6 Sigma, Kaizen, Quality Circles etc., but do not understand that no system can remain or give results unless one has the basic discipline of planning and establishing the systems, implementing them through out the organization, monitoring and measuring the performance, correct the deviations and take preventive actions with the involvement of people and a committed management. The real implementation actually reduces the work, as you will be auditing, identifying the non-conformities and taking corrective and preventive actions, and go on improving your systems on a continual basis. As the activities are customer-focused, the sale is guaranteed.
In this book, I have tried to explain the real need for implementing the systems, the steps in implanting, the roles and responsibilities of management representative, making effective internal quality audits by linking exercises, assessing the level of implementation of ISO 9001, inviting complaints and treating customer as a free consultant, and freely facing the audits. I hope this book will drive out some of the misconcepts and help the organizations to become strong and competitive.
B. Purushothama