RATIONALE
FOREWORD
INTRODUCTION
QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS
1 SCOPE
1.1 General
1.2 Application
2 NORMATIVE REFERENCES
3 TERMS AND DEFINITIONS
3.1 Noncomplex Product
3.2 Critical Items
3.3 Key Characteristic
4 QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
5 MANAGEMENT RESPONSIBILITY
5.1 Customer Focus
5.2 Responsibility, Authority, and Communication
5.2.1 Responsibility and Authority
5.2.2 Management Representative
6 RESOURCE MANAGEMENT
6.1 Human Resources
6.2 Work Environment
7 PRODUCT REALIZATION
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
7.2.2 Review of Requirements Related to the Product
7.3 Purchasing
7.3.1 Purchasing Process
7.3.2 Purchasing Information
7.3.3 Verification of Purchased Product
7.4 Production and Service Provision
7.4.1 Control of Production and Service Provision
7.4.2 Validation of Processes for Production and Service Provision
7.4.3 Identification and Traceability
7.4.4 Customer Property
7.4.5 Preservation of Product
7.5 Control of Monitoring and Measuring Equipment
8 MEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.1 Monitoring and Measurement
8.1.1 Monitoring and Measurement of Processes
8.1.2 Monitoring and Measurement of Product
8.2 Control of Nonconforming Product
8.3 Corrective Action