ISO 13485 specifies requirements for a quality management system for manufacturing of medical devices where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The key objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems.
Benefits of ISO 13485
ISO 13485 drives best practice and helps organizations:
- Help to motivate staff and provide a better definition of roles and key responsibilities.
- Specifically tailored for the medical devices industry helps the organization to demonstrate its ability to systematically provide medical devices and services that consistently meet customer requirements, meet applicable regulatory requirements (compliance) and safety standards.
- Provides a systematic approach to risk management/ risk assessment.
- Systematic, smoother, transparent and documented handling of activities required by regulations such as post-marketing follow-up and surveillance, complaints handling, process validation installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), field corrective actions or product recall handling, vigilance and competent authorities reporting, and clinical experience enrichment.
