Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Context of the organization

   4.1 Understanding the organization and its context

   4.2 Understanding the needs and expectations of interested parties

   4.3 Determining the scope of the quality management system

   4.4 Quality management system and its processes

5 Leadership

   5.1 Leadership and commitment

   5.2 Policy

   5.3 Organizational roles, responsibilities and authorities

6 Planning

   6.1 Actions to address risks and opportunities

   6.2 Quality objectives and planning to achieve them

   6.3 Planning of changes

7 Support

   7.1 Resources

   7.2 Competence

   7.3 Awareness

   7.4 Communication

   7.5 Documented information

8 Operation

   8.1 Operational planning and control

   8.2 Requirements for products and services

   8.3 Design and development of products and services

   8.4 Control of externally provided processes, products and services

   8.5 Production and service provision

   8.6 Release of products and services

   8.7 Control of nonconforming outputs

9 Performance evaluation

   9.1 Monitoring, measurement, analysis and evaluation

   9.2 Internal audit

   9.3 Management review

10 Improvement

  10.1 General

  10.2 Nonconformity and corrective action

  10.3 Continual improvement

 Annex A Clarification of new structure, terminology and concepts

  A.1 Structure and terminology

  A.2 Products and services

  A.3 Understanding the needs and expectations of interested parties

  A.4 Risk-based thinking

  A.5 Applicability

  A.6 Documented information

  A.7 Organizational knowledge

  A.8 Control of externally provided processes, products and services

Annex B Other International Standards on quality management and quality management systems developed by ISO/TC 176

Bibliography