ISO 9001:2015 – A Complete Guide to Quality Management Systems PDF by Itay Abuhav

By

ISO 9001:2015-A Complete Guide to Quality Management Systems

By Itay Abuhav

ISO 9001 2015 A Complete Guide to Quality Management Systems

Contents

Preface ix

Acknowledgments xi

Author xiii

Scope 1

Normative References 3

Terms and Definitions 5

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

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

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

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

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

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 Identification 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

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

9.3 Management Review 386

9.3.1 General 387

9.3.2 Management Review Inputs 387

9.3.3 Management Review Outputs 387

Improvement 397

10.1 General 397

10.2 Nonconformity and corrective action 404

10.3 Continual Improvement 415

Index 421

Preface

The 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. The new revision of the standard introduces new challenges to the organization but also a revision to old challenges. This book is a complete guide to implementing all the requirements of the standard. In order to present the reader with a practical and useful guide, I have provided a definition of my quality policy and objectives.

My Quality Policy

Presenting and reviewing the ISO 9001:2015 standard requirements through analysis, 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 effective 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 ineffective without also having in place designed and structured tactics and methods to achieve them:

  • The 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 effectiveness, and documented information.
  • The ISO 9001:2015 standard acts like a complicated web of prerequisites with relations between them. A full and comprehensive reference to the interrelations between the different clauses and sub-clauses has been included.
  • Putting words into actions—the book will assist in translating the requirements and objectives into feasible activities and tasks. It visualizes situations with everyday events from the different sectors, branches, and products or services.

List of Exclusions

I decided to exclude chapter 0 of the standard from this book since it mainly provides explanations regarding the ISO 9001:2015 that are already covered elsewhere in this book.

My biggest wish is that you, as a reader, will refer to this book as a consulting session; that you will read and explore it, draw information and knowledge that suit you and your organization; and that you will introduce this information to your quality management system and processes.

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