BS EN ISO 20166-3:2019
Comprehensive standard for quality management of healthcare technology, ensuring patient safety and regulatory compliance.
BS EN ISO 20166-3:2019 - Healthcare Technology Standard for Quality Management
The BS EN ISO 20166-3:2019 is a crucial standard for healthcare organisations, providing guidance on quality management systems and best practices for the provision of healthcare technology. Developed by the International Organization for Standardization (ISO), this standard ensures that healthcare technology is designed, implemented, and maintained to the highest quality and safety standards.
Key Benefits of Implementing BS EN ISO 20166-3:2019
- Enhances patient safety and clinical outcomes by ensuring the reliability and performance of healthcare technology
- Establishes a comprehensive quality management system to support the entire lifecycle of healthcare technology, from planning and procurement to ongoing maintenance and decommissioning
- Helps healthcare organisations comply with relevant regulations and industry best practices, reducing the risk of non-compliance and associated penalties
- Promotes continuous improvement by identifying and addressing quality issues, leading to more efficient and effective healthcare technology management
- Fosters a culture of quality and accountability within healthcare organisations, empowering staff to take ownership of their roles and responsibilities
Scope and Key Requirements of BS EN ISO 20166-3:2019
The BS EN ISO 20166-3:2019 standard covers the quality management requirements for healthcare technology, including medical devices, laboratory equipment, and supporting infrastructure. It outlines a systematic approach to planning, implementing, and maintaining a comprehensive quality management system, addressing key areas such as:
- Risk management and safety considerations
- Procurement and supplier management
- Installation, commissioning, and decommissioning
- Training and competency management for healthcare technology users
- Maintenance, repair, and calibration procedures
- Incident reporting and corrective actions
- Continuous improvement and performance monitoring
By adhering to the requirements of BS EN ISO 20166-3:2019, healthcare organisations can demonstrate their commitment to quality and patient safety, while also optimising the performance and cost-effectiveness of their healthcare technology investments.
Technical Information
Specification Details
- Molecular in vitro diagnostic examinations
- Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Isolated DNA