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International Accreditation of Healthcare Facilities

Standards › Standard 33 › Registers and logs

Register · LBT-REG-003 · Version 1.0 · Approved by the ASF Expert Committee

Supports: 33.4

Purpose

Records the quality control result for each run, the rule applied, the release decision and any corrective action.

How to complete

Checks

Check Entry
Run date and test Yes
Control result and limit Yes
Rule applied and review Yes
Release or hold decision Yes
Corrective action Yes

Evidence

Reference Note
E-009 Based on ISO 15189:2022 Medical laboratories: requirements for quality and competence, ISO 9001:2015 for supplier control, and the Global Patient Safety Action Plan 2021–2030 for critical results.
E-006 ASF Policy Framework v1.2. Adapted.
E-009 ASF Expert Committee consensus.

Change history

Version Date What changed Approval
1.0 the date of approval First version set Expert Committee approval

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References

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