ISO 9000 Quality Management system, developed as a by product of Second World War is accepted world over as a standard guideline for achieving the company objectives and customer satisfaction with zero mistakes while adhering to ethical practices by following proven documented system. The world is changing and accordingly the standards are also being amended from time to time in order to suit the changing requirements of customers, technology, environment and the stakeholders. The ISO 9000 guidelines, which were derived from BS 5750:1096 were accepted as International Standards in 1987, and was amended in 1996, 2000 and 2008. The standards are being completely rewritten with different clauses in 2015, and the committee draft is circulated world over.
It is suggested that everyone read the draft and identify the gaps they have considering the proposed guidelines. There are number of changes in the guidelines, but it does not call for discontinuing any of the present steps developed as per ISO 9001:2008 standards. There are number of new things we need to implement, if we are not doing it now.
In order to be successful in the business, it is necessary to understand the new clauses and align all our activities in line with the standards. Effort is made to explain the clauses in simple languages so that an ordinary person can also understand the inner intention of the clauses which if implemented by heart shall help the company in achieving its objectives and goals and make their vision a reality while adhering to their mission.
This book is written considering the document ISO/TC/176/SC2/N-1147 released on 3rd June 2013 to help the industry to align themselves to the new standards by the time it is released.
It is a normal practice to write guide books for implementing the standards after the publication of new standards. In legal cases or trade regulations, one has to stick to the requirements as per the standard, whereas in case of Quality Management System, the guidelines are minimum requirements and you can adapt a much better system. There is no need to wait for the publication of new standards, but start implementing them from now itself, so that one can get the benefits of new guidelines. Even if some points is deleted from the draft while releasing the new standards, there shall be no loss to the implementer as it is going to make the company stronger and competitive. With this intention, this book is written in advance so that companies can implement the new systems proactively.
Time runs out very fast, and hence we need to do the planning proactively and implement the things in time so that we can be competitive. Even the companies, those have not applied for ISO 9001 certification can also implement the ISO 9001 guidelines so that they become strong internally. Please remember that daily practice of good system makes the man perfect.
Preface ix Foreword xi
1 Why 2015 version is being discussed now? 1
2 Quality management principle 3 QMP 1 – Customer focus 4 QMP 2 – Leadership 5 QMP 3 – Engagement of people 5 QMP 4 – Process approach 5 QMP 5 – Improvement 6 QMP 6 – Evidence-based decision-making 6 QMP 7 – Relationship management 7 3 Clause No. 1 – Scope 9 1.1 Scope 9 1.2 Application 10 4 Clause No. 2 – Normative Reference 13 Clause No. 2, viz. Normative Reference reads as follows 13 5 Clause No. 3 – Terms and Definitions 15 6 Clause No. 4 – Context of the organization 21 4 Context of the organization 21 4.1 Understanding the organization and its context 21 4.2 Understanding the needs and expectations of interested parties 24 4.3 Determining the scope of the quality management system 30 4.4 Quality management system 32
7 Clause No. 5 – Leadership 37 5.1 Leadership and commitment 42 5.2 Quality policy 45 5.3 Organizational roles, responsibilities, and authorities 47 8 Clause No. 6 – Planning 49 6.1 Actions to address risks and opportunities 49 6.2 Quality objectives and planning to achieve them 51 6.3 Planning of changes 55 9 Clause No. 7 – Support 59 7 Support 59 7.1 Resources 59 7.2 Competence 67 7.3 Awareness 73 7.4 Communication 76 7.5 Documented information 78 10 Clause No. 8 – Operation 85 8 Operation 85 8.1 Operational planning and control 85 8.2 Determination of market needs and interactions with customers 89 8.3 Operational planning process 93 8.4 Control of external provision of goods and services 95 8.5 Development of goods and services 99 8.6 Production of goods and provision of services 106 8.7 Release of goods and services 113 8.8 Nonconforming goods and services 114 11 Clause No. 9 – Performance evaluation 117 9 Performance evaluation 117 9.1 Monitoring, measurement, analysis, and evaluation 117 9.2 Internal audit 121
9.3 Management review 123 12 Clause No. 10 – Continual improvement 127 10 Continual improvement 127 10.1 Nonconformity and corrective action 127 10.2 Improvement 129 13 Difference between 2008 and 2015 versions 131 Appendix 1 A typical format for work procedure 141 Appendix 2 A typical format for job description 145 Appendix 3 A typical work instruction 147 Appendix 4 Typical formats for writing internal quality audit reports 151 Appendix 5 A typical document change note 155 Appendix 6 A typical format for documenting minutes of meeting 157 References 159 Index 161