ISO 13485 (ISO 13485:2003)
John E. Lincoln, principal consultant, J. E. Lincoln and Associates
Medical Devices / Pharmaceuticals / Quality / Regulatory Affairs
ISO 13485:2003 -- MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM (QMS)
0 Introduction
0.1 General
0.2 Process approach
0.3 Relationship with other standards
0.4 Compatibility with other management systems
1 Scope
1.1 General
1.2 Application
2 Normative references
3 Terms and definitions
3.1 active and implantable medical device
3.2 active medical device
3.3 advisory notice
3.4 customer complaint
3.5 implantable medical device
3.6 labeling
3.7 medical device (per Global Harmonization Task Force)
3.8 sterile medical device
4 Quality management system
4.1 General requirements ("The organization shall establish, document, implement and maintain a QMS