Scope Normative References Terms and Definitions Context of the Organization Understanding the Organization and Its Context Understanding the Needs and Expectations of Interested Parties Determining the Scope of the Quality Management System Quality Management System and Its Processes Leadership Leadership and Commitment General Customer Focus Policy Establishing the Quality Policy Communicating the Quality Policy Organizational Roles, Responsibilities, and Authorities Planning Actions to Address Risks and Opportunities Quality Objectives and Planning to Achieve Them Planning of Changes Support Resources General People Infrastructure Environment for the Operation of Processes Monitoring and Measuring Resources Organizational Knowledge Competence Awareness Communication Documented Information General Creating and Updating Control of Documented Information Operation Operational Planning and Control Requirements for Products and Services Customer Communication Determining the Requirements for Products and Services Review of Requirements for Products and Services Changes to Requirements for Products and Services Design and Development of Products and Services General Design and Development Planning Design and Development Inputs Design and Development Controls Design and Development Outputs Design and Development Changes Control of Externally Provided Processes, Products, and Services General Type and Extent of Control Information for External Providers Production and Service Provision Control of Production and Service Provision Identification and Traceability Property Belonging to Customers or External Providers Preservation Post-Delivery Activities Control of Changes Release of Products and Services Control of Nonconforming Outputs Performance Evaluation Monitoring, Measurement, Analysis, and Evaluation General Customer Satisfaction Analysis and Evaluation Internal Audit Management Review General Management Review Inputs Management Review Outputs Improvement General Nonconformity and corrective action Continual Improvement.