ISO 9001: 2015 A Complete Guide to Quality Management Systems

444 Pages·2017·12.65 MB·English

by  Itay Abuhav

ISO 9001:2015—
A Complete Guide to
Quality Management
Systems
ISO 9001:2015—
A Complete Guide to
Quality Management
Systems
Itay Abuhav
Taylor & Francis Group
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Contents
Preface ix
Acknowledgments xi
Author xi
1. Scope 1
2. Normative References 3
3. Terms and Defnitions 5
4. Context of the Organization 7
4.1 Understanding the Organization and Its Context 7
4.2 Understanding the Needs and Expectations of Interested Parties 15
4.3 Determining the Scope of the Quality Management System 18
4.4 Quality Management System and Its Processes 22
5. Leadership 39
5.1 Leadership and Commitment 39
5.1.1 General 39
5.1.2 Customer Focus 47
5.2 Policy 50
5.2.1 Establishing the Quality Policy 51
5.2.2 Communicating the Quality Policy 51
5.3 Organizational Roles, Responsibilities, and Authorities 56
6. Planning 67
6.1 Actions to Address Risks and Opportunities 67
6.2 Quality Objectives and Planning to Achieve Them 81
6.3 Planning of Changes 94
7. Support 101
7.1 Resources 101
7.1.1 General 101
7.1.2 People 104
7.1.3 Infrastructure 104
7.1.4 Environment for the Operation of Processes 112
v
vi Contents
7.1.5 Monitoring and Measuring Resources 120
7.1.6 Organizational Knowledge 130
7.2 Competence 140
7.3 Awareness 147
7.4 Communication 151
7.5 Documented Information 157
7.5.1 General 158
7.5.2 Creating and Updating 170
7.5.3 Control of Documented Information 175
8. Operation 189
8.1 Operational Planning and Control 189
8.2 Requirements for Products and Services 208
8.2.1 Customer Communication 208
8.2.2 Determining the Requirements for Products and Services 216
8.2.3 Review of Requirements for Products and Services 220
8.2.4 Changes to Requirements for Products and Services 225
8.3 Design and Development of Products and Services 227
8.3.1 General 228
8.3.2 Design and Development Planning 229
8.3.3 Design and Development Inputs 236
8.3.4 Design and Development Controls 242
8.3.5 Design and Development Outputs 248
8.3.6 Design and Development Changes 253
8.4 Control of Externally Provided Processes, Products, and Services 258
8.4.1 General 258
8.4.2 Type and Extent of Control 267
8.4.3 Information for External Providers 275
8.5 Production and Service Provision 282
8.5.1 Control of Production and Service Provision 282
8.5.2 Identifcation and Traceability 305
8.5.3 Property Belonging to Customers or External Providers 314
8.5.4 Preservation 318
8.5.5 Post-Delivery Activities 323
8.5.6 Control of Changes 331
8.6 Release of Products and Services 335
8.7 Control of Nonconforming Outputs 341
9. Performance Evaluation 353
9.1 Monitoring, Measurement, Analysis, and Evaluation 353
9.1.1 General 353
9.1.2 Customer Satisfaction 362
9.1.3 Analysis and Evaluation 369
9.2 Internal Audit 375
Contents vii
9.3 Management Review 386
9.3.1 General 387
9.3.2 Management Review Inputs 387
9.3.3 Management Review Outputs 387
10. Improvement 397
10.1 General 397
10.2 Nonconformity and corrective action 404
10.3 Continual Improvement 415
Index 421
Preface
Te quality management world is about to go through a big change represented by
the publication of the new revision of the ISO 9001 Standard: the 2015 revision. Te
new revision of the standard introduces new challenges to the organization but also
a revision to old challenges. Tis book is a complete guide to implementing all the
requirements of the standard. In order to present the reader with a practical and use-
ful guide, I have provided a defnition of my quality policy and objectives.
My Quality Policy
Presenting and reviewing the ISO 9001:2015 standard requirements through analy-
sis, interpretation, and demonstration, with explanations, insightful examples, and
events from various industries and sectors.
My Quality Objectives
• Commitment to the highest level of consulting regarding the ISO 9001:2015 standard
• Reviewing all the topics and issues related to the realization of a product or service
with reference to various types of processes and products
• Providing support in the implementation of an efective quality management system
• Facilitating the documentation of processes
• Providing references to the new challenges presented in the ISO 9001:2015 standard
However, a policy and related objectives are inefective without also having in place
designed and structured tactics and methods to achieve them:
• Te book is designed and structured to mirror the standard’s table of contents in
order to simplify navigation and use.
• Each clause and sub-clause of the standard are discussed and analyzed through
quality perspectives, such as the implications for an organization—its processes,
risk-based thinking, resources, infrastructures, process environment, control and
efectiveness, and documented information.
ix