Implementing ISO 9001

174 Pages·2014·2.64 MB·English

by  Purushothama

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.
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Version Date: 20150227
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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.