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Back to Standards/Criterion 09E.1.3.13
09E.1.3.13
Facilities and equipment

Implant Traceability Protocol 1.3

The Orthopaedic Services department establishes, implements and monitors documented operational procedures ensuring quality, clinical safety and regular compliance audits for implant traceability.

Compliance Criteria

  • 1Approved standard operating procedure for implant traceability reviewed within the last 3 years
  • 2Designated qualified personnel assigned to monitor day-to-day implant traceability compliance
  • 3Regular documentation audits and evidence of corrective action implementation
  • 4Staff training records and competency assessments maintained in the department

Hospital Self-Rating

Rated by Dr. Azmi Razak on 13 Jan 2026

Evidence frozen on 30 March 2026 (14 days before survey)

"The department has established comprehensive operational policies for implant traceability. Regular self-assessments and internal quality checks demonstrate consistent compliance across all operational shifts."

Evidence Documents (0)

A criterion with no document reads as unevidenced to the survey team.

Attach relevant hospital policies, registers, audit reports, or training records.

AR
Person-in-ChargeHead of Clinical Services & Consultant Physician
Head of DepartmentHead of Clinical Services & Consultant Physician
AR
Surveyor Authority PaneAssigned: Dr. Mohd Anis Haron (Lead Surveyor)

Surveyor Rating

Committed 15 Apr 2026

Departmental surveillance for implant traceability lacks continuous trend analysis and formal closure evidence on identified non-conformances.

Establish continuous supervisory sign-off audits and enforce documented shift compliance for implant traceability.

Implement monthly documentation audits and review adherence rates during departmental quality meetings.