UKAB audit process
See the official sources listed in the references table at the bottom of this page.
This site provides general information only and does not constitute legal or regulatory advice.
Overview
The stages of a UK Approved Body audit — from initial application through document review, on-site audit, certificate decision, and ongoing surveillance.
Overview of the UKAB audit process
The UKAB conformity assessment process follows these stages:
1. Initial enquiry and scoping Contact the UKAB, provide a product description, and confirm they are designated for your device type and required procedure. Discuss timelines and costs.
2. Formal application Submit a formal application with initial documentation — quality manual, technical file summary or design dossier, classification rationale.
3. Contract and application review UKAB reviews the application, confirms scope, issues a contract, and assigns an audit team.
4. Document review UKAB reviews QMS documentation and/or technical file / design dossier. Requests for additional information (RFIs) are issued and must be responded to. This is an iterative process.
5. On-site audit UKAB auditors visit the manufacturing site(s):
- Review QMS records, procedures, and implementation
- Interview staff across design, manufacturing, quality, and regulatory functions
- Observe manufacturing processes
- Identify and categorise non-conformities (major, minor, observation)
6. Non-conformity resolution Major non-conformities must be resolved (corrective action plans submitted and accepted) before a certificate can be issued. Minor non-conformities may be resolved within a defined timeframe post-certificate.
7. Certificate decision UKAB reviews all findings and decides whether to issue the certificate. For Class III devices: Design Examination Certificate issued per device design; QMS Certificate issued per quality system.
8. Ongoing surveillance After certification:
- Annual planned surveillance audits — review of QMS and PMS activities
- Unannounced audits — UKAB right to audit without prior notice
- Certificate renewal — typically every 5 years
Typical timelines
| Stage | Typical duration |
|---|---|
| Class I (sterile/measuring/Im) — UKAB partial involvement | 1–3 months |
| Class IIa/IIb — full QMS audit | 3–9 months |
| Class III — full QMS + design dossier | 6–18 months |
| IVD List A — full assessment | 6–18 months |
These are indicative — actual timelines depend on device complexity, technical file completeness, and UKAB capacity.
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 3 | Conformity assessment procedures |
| MHRA: UK Approved Bodies | UKAB requirements and oversight |
| ISO 13485:2016 | QMS standard — basis for UKAB QMS audit |