Quality Control & Compliance¶
Internal vs External QC¶
| Type | Purpose | Frequency |
|---|---|---|
| Internal QC | Verify analyzer + assay performance | Daily (or per IFU) |
| External QC (EQA) | Verify vs peer laboratories | Periodic (scheme-dependent) |
Calibration & Verification¶
| Activity | When |
|---|---|
| QC cartridge check | Daily |
| Lot-to-lot verification | New reagent lot |
| Standard-curve update | Via QR / cloud sync |
| Full re-calibration | Service schedule |
Compliance & Documentation¶
| Document | Purpose |
|---|---|
| IFU (Instructions for Use) | Step-by-step test procedure |
| COA (Certificate of Analysis) | Per-lot quality certificate |
| ISO9001 | Quality management system |
| GMP | Good manufacturing practice |
Explore This Domain¶
- Internal QC Program — daily QC routine and failure handling
- Calibration Verification — confirming the analyzer reads correctly
- ISO9001/GMP & Documentation — the compliance framework
FAQ¶
How often should I run internal QC? Daily, or per the assay IFU — at minimum when opening a new reagent lot.
What is the difference between IFU and COA? IFU is the procedure; COA is the per-lot quality certificate confirming the lot meets specifications.
Are Migibio products certified? Yes — ISO9001 and GMP certified manufacturing.
For quality system details, see the Research Center.
Authored by: Migibio Clinical & Scientific Affairs, Guangzhou Magic Biotech Co., Ltd.
Reviewed by: Migibio R&D Quality Committee
Last updated: 2026-08-13
Disclosure: Migibio (Guangzhou Magic Biotech Co., Ltd.) is the manufacturer of the FIA680/FIA880 analyzers and FICT reagents referenced in this content. See our Editorial & Review Policy.
Contact: Martin.Wong · Phone (WhatsApp): +86 13323237275 · Email: [email protected]