Standards › Standard 33 › Forms
Form · LBT-FRM-001 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 33.2
Purpose
Records the check of each new reagent lot against the previous lot or the manufacturer’s criteria before first use.
How to complete
- Check each new lot on receipt against the acceptance criteria.
- Record the result and the criteria used.
- Record any lot that fails and its removal from use.
Checks
| Check | Entry |
|---|---|
| Reagent, lot and receipt date | Yes |
| Criteria used (previous lot or manufacturer) | Yes |
| Result (pass or fail) | Yes |
| First use date and person | 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)