ISO9001, GMP & Documentation: The Compliance Framework¶
Migibio operates under ISO9001 (quality management) and GMP (Good Manufacturing Practice). This page explains what those certifications mean and how they translate into the documentation you receive with every product.
The Certifications¶
| Certification | Scope | What it guarantees |
|---|---|---|
| ISO9001 | Organization-wide quality management | Consistent, documented processes |
| GMP | Reagent manufacturing | Controlled production environment and process |
The Documents You Receive¶
| Document | Purpose |
|---|---|
| IFU (Instructions for Use) | The legally controlling document — how to use the assay correctly |
| COA (Certificate of Analysis) | Lot-specific performance data for the specific batch you received |
Why the IFU Is Controlling¶
The IFU is the legally controlling document. Where this knowledge base (or any other reference) differs from the IFU, the IFU governs. Always read the IFU for each assay lot.
Documentation Hierarchy¶
Each layer depends on the one before it. The COA certifies the lot; the IFU tells you how to use it.
What This Means for You¶
- Traceability — every result traces to a documented, validated lot.
- Defensibility — a documented QC + COA chain supports your results in disputes or audits.
- Confidence — the assay was manufactured under controlled conditions.
FAQ¶
What is the difference between ISO9001 and GMP? ISO9001 is a general quality-management standard; GMP is specific to manufacturing. Migibio holds both.
Where do I find the COA? It ships with the product lot; contact your distributor or [email protected] for a specific lot's COA.
For the QC program, see Internal QC Program.
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.