Académique Documents
Professionnel Documents
Culture Documents
Management System
Presented By
[Presenter Name]
[Presenter Title]
Regulations of
medical devices
Research and
development
based on
Approved high
needs
cost Medical
devices Post market surveillance and Adverse event
Approved reporting
Needs
Medical devices
Assessments/
lists
Selection
Donations
Installation,
User training
Health Procurement Inventories; and clinical
Technology CMMS, effectivenes
Assessment Maintenance s
Decommissioning
, Replacement
Glossary
Policies of Human resources on Medical
medical devices for Medical devices
devices
Evaluation Phase 2
Phase 7 Selection
Training
Phase 3
Data collection
Phase 6
Phase 4
Data entry
Installation
Phase 5
Configuration and
customization
Entered values
Equipment fault
logged on CMMS
Inventory
IPM schedule Work order
CMMS
generated
No
Job
Stores manager Parts required to Completed?
complete job? No
Yes
Yes
Parts available? Job execution
Parts received
No
Quality assurance
– Technical (safety of medical equipment)
– Equipment performance
– DT, LCC, compliance, failure analysis
– Cost monitoring
Determine fields referred to in Determine procedure Determine needed Determine output data
procedure activities approvals
Budget limitations
– Proper budget planning and allocation is needed
– Consider phases
IT infrastructure
– Study IT infrastructure and then decide connection
Language of CMMS
– Locally developed CMMS have advantage here
Tender
Equipment Requirements Equipment
Planning Reception
Reporting
Warranty
System
Control
Equipment
inventory The Automation Preventive &
corrective
Maintenance
System
Technical
Quality
library
Control
control
Equipment Contract
Scrapping Managemen
Spare Parts t
Control
Computerized maintenance
management system
April 2011
http://www.who.int/medical_devices/en/
mailto:medicaldevices@who.int