Cover -- Half Title -- Title Page -- Copyright Page -- Table of Contents -- Preface -- Acknowledgments -- Author -- 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 -- 5.1.1 General -- 5.1.2 Customer Focus -- 5.2 Policy -- 5.2.1 Establishing the Quality Policy -- 5.2.2 Communicating the Quality 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 -- 7.1.1 General -- 7.1.2 People -- 7.1.3 Infrastructure -- 7.1.4 Environment for the Operation of Processes -- 7.1.5 Monitoring and Measuring Resources -- 7.1.6 Organizational Knowledge -- 7.2 Competence -- 7.3 Awareness -- 7.4 Communication -- 7.5 Documented Information -- 7.5.1 General -- 7.5.2 Creating and Updating -- 7.5.3 Control of Documented Information -- 8: Operation -- 8.1 Operational Planning and Control -- 8.2 Requirements for Products and Services -- 8.2.1 Customer Communication -- 8.2.2 Determining the Requirements for Products and Services -- 8.2.3 Review of Requirements for Products and Services -- 8.2.4 Changes to Requirements for Products and Services -- 8.3 Design and Development of Products and Services -- 8.3.1 General -- 8.3.2 Design and Development Planning -- 8.3.3 Design and Development Inputs -- 8.3.4 Design and Development Controls -- 8.3.5 Design and Development Outputs -- 8.3.6 Design and Development Changes