Core Purpose and Scope

• Quality Assurance: The scheme’s primary goal is to ensure the efficacy, safety, and reliability of medical equipment after installation, servicing, or repair.
• Standards Compliance: It is developed in compliance with international standards, specifically ISO/IEC 17065:2012 for conformity assessment.
• Applicability: It covers the maintenance of medical equipment and systems that require periodic maintenance but excludes single-use devices and implantable medical devices.

Implementation Models

The certification can be implemented by three types of maintenance providers:

1. In-house Hospital Departments: For example, CMC Vellore became the second institution globally to achieve this certification for its 6,500+ in-house managed devices.
2. Original Equipment Manufacturers (OEMs): Maintenance performed directly by the manufacturer.
3. Third-Party Providers: Independent agencies providing maintenance services (AMC/CMC).

Benefits

• Patient Safety: Reduces the risk of hazards from malfunctioning equipment.
• Operational Efficiency: Minimizes downtime and ensures equipment works as per manufacturer guidelines.
• Regulatory Compliance: Helps healthcare facilities meet industry regulations and enhances trust with doctors and patients.