Standards › Standard 33 › Registers and logs
Register · LBT-REG-002 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 33.3
Purpose
Records each method validation and each change that triggered revalidation, with the date of first patient use.
How to complete
- Log each validation and its report.
- Log each change and its revalidation.
- Record the date of first patient use.
Checks
| Check | Entry |
|---|---|
| Method and validation report date | Yes |
| Precision, accuracy, reportable range and reference interval covered | Yes |
| Change and revalidation date | Yes |
| First patient use date | 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 |
E-learning for this document
- Equipment, Reagents & Traceability (LAB-04)
References
- Accréditation Sans Frontières (2026). ASF Policy Framework v1.2. (E-006)
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)