We have a principal document that we call, "Quality Manual"...it states at a high level how we intend to be compliant to QMS...here's the table of contents of our QM (our QM is 29 pages long)
SECTION 4.0 Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
SECTION 5.0 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, Authority and Communication
Organizational Chart
Business Process Map
5.6 Management Review
SECTION 6.0 Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
SECTION 7.0 Product Realization
7.1 Planning of Product Realization
7.2 Customer-related Processes
7.3 Design and Development
7.4 Purchasing
7.5 Production and Service Provision
7.6 Control of Monitoring and Measuring Devices
SECTION 8.0 Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and Measurement
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
Appendix 1 Correlation Matrix for FDA QSR and Company procedures
Appendix 2 Correlation Matrix for ISO 13485:2003 and Company Procedures
Appendix 3 Quality Management System Planning Chart
Appendix 4 Product Realization Planning
Appendix 5 Design and Development Planning
Appendix 6 Measuring and Monitoring Planning
Revision History
Hope this helps