Surveyor Consensus & Allocation Dispute
Team leader to resolveLead SurveyorDr Mohd Anis HaronAssigned Service Standard Lead
Rating SurveyorFully met
Mr Ganesh PillaiRecorded finding during tracer inspectionAwaiting Dr Mohd Anis Haron (Lead Surveyor) resolution. Dual surveyor observations are recorded with full provenance and decided strictly by clinical leadership authority.
4.3.1
Safety and performance improvement activitiesMedical Device Safety Alerts and Recall Management
A documented procedure is established for receiving, evaluating, executing and documenting medical device safety alerts, recalls and field safety notices from MDA.
Compliance Criteria
- 1Formal SOP for handling Medical Device Authority (MDA) safety alerts and recalls
- 2Designated biomedical safety officer responsible for alert dissemination
- 3Written record of affected asset tracing and vendor remediation
- 4Closed-loop recall register submitted to Quality Assurance Committee
Hospital Self-Rating
Rated by En. Hakim Osman on 20 Jan 2026Evidence frozen on 30 March 2026 (14 days before survey)
"Medical Device Authority safety alerts and manufacturer field safety notices are logged and executed with completed action logs."
thin
Evidence documents establish procedural intent but lack documented verification records for the current audit period.
Unverified criteria:
- Written record of affected asset tracing and vendor remediation
- Closed-loop recall register submitted to Quality Assurance Committee
Derived from AccrediSense Evidence Engine · 1 document(s) attached with 2 unverified criteriaGovernance disclosure (1.4.1.4)
Evidence Documents (1)
RegisterAcceptedScore: 90/100
Medical Device Authority (MDA) Safety Alert & Recall Action Dossier
22 pages · ENValid: 2025-01-01 to 2026-12-31
HO
Person-in-ChargeHead of Facilities & Biomedical Engineering
Head of DepartmentQuality Manager
RI
Surveyor Authority PaneAssigned: Mr. Ganesh Pillai (Engineering & Facilities Surveyor)