Implementing ISO 9001:2015 TThhiiss ppaaggee iinntteennttiioonnaallllyy lleefftt bbllaannkk Implementing ISO 9001:2015 B. Purushothama WOODHEAD PUBLISHING INDIA PVT LTD New Del hi, India CRC Press Woodhead Publishing India Pvt. Ltd. Taylor & Francis Group 303, Vardaan House, 7/28, Ansari Road 6000 Broken Sound Parkway NW, Suite 300 Daryaganj, New Delhi – 110002, India Boca Raton, FL 33487-2742 © 2015 by Woodhead Publishing India Pvt. Ltd. Exclusive worldwide distribution by CRC Press an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Version Date: 20150227 International Standard Book Number-13: 978-93-80308-93-7 (eBook - PDF) This book contains information obtained from authentic and highly regarded sources. Reason- able efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. 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Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com For information about WPI Publishing visit their website at http://www.woodheadpublishingindia.com Contents 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 U nderstanding the needs and expectations of interested parties 24 4.3 D etermining the scope of the quality management system 30 4.4 Quality management system 32 vi Contents 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 D etermination of market needs and interactions with customers 89 8.3 Operational planning process 93 8.4 C ontrol 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 M onitoring, measurement, analysis, and evaluation 117 9.2 Internal audit 121 Contents vii 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 TThhiiss ppaaggee iinntteennttiioonnaallllyy lleefftt bbllaannkk Preface 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.