ISO 15189 · ISO/IEC 17025 · UKAS Accreditation
Independent laboratory audits, and a steady route to UKAS accreditation.
STEMGENE LTD helps diagnostic and testing laboratories prepare for and maintain UKAS accreditation, and helps companies who outsource testing audit the labs they depend on. Over a decade of hands-on laboratory quality leadership, working directly against the clauses that apply to your scope.
Services
Accreditation and audit work, scoped to the standard
Every engagement is built around the clauses that apply to your scope of accreditation, not sold as a fixed package.
ISO 15189:2022
ISO 15189 accreditation support
End-to-end preparation for medical and clinical laboratory accreditation, from first gap assessment to the UKAS visit.
- Gap assessment against the current standard
- Quality management system documentation
- Method verification and validation records
ISO/IEC 17025
ISO 17025 accreditation support
Preparation for testing and calibration laboratory accreditation, with a clearly defined scope and technical evidence base.
- Scope of accreditation definition
- Measurement uncertainty and method validation
- Technical procedure documentation
UKAS Assessment
UKAS mock audits & application preparation
A full dry run of the UKAS assessment before the real thing, plus support through the application itself.
- Mock assessment against applicable clauses
- Non-conformance identification and closure
- On-site support during the UKAS visit
Supplier & For-Cause
Supplier audits of accredited labs
Independent audits for companies outsourcing testing or trial work, giving you documented assurance over the labs you rely on.
- For-cause and routine supplier audits
- Formal written audit report and appendices
- Corrective action tracking to closure
Sample integrity
Every sample has a chain of custody. So should your accreditation.
The same discipline that keeps a sample traceable from collection to result is what keeps a laboratory audit-ready between assessments. We build both.
Who we help
Two sides of the same standard
Laboratories seeking accreditation
Diagnostic, clinical, and testing laboratories preparing for first-time UKAS accreditation, or re-accreditation, who want to walk into the assessment already knowing what the assessor will find.
Labs maintaining accreditation
Accredited laboratories that need a dependable internal audit cycle and document control rhythm, so accreditation is maintained between surveillance visits rather than rebuilt each cycle.
Companies outsourcing testing
Sponsors and manufacturers who send testing or trial work to external accredited labs, and need independent supplier audits to evidence oversight of those suppliers.
How an engagement runs
A clear sequence, from first look to steady state
Gap assessment
A baseline audit against every applicable clause, logged the way a UKAS assessor would log it. You get findings, not a vague scorecard.
Documentation and evidence
Quality manual, procedures, and records structured to the standard and written to be used by your team, not just filed for the assessment.
Mock audit
A full dry run of the UKAS assessment. Non-conformances are raised, owned, and closed before the official visit.
Assessment support
On-site presence during the UKAS assessment, ready to locate evidence and provide context in real time.
Ongoing compliance
An internal audit cycle and document control rhythm that keeps accreditation maintained between surveillance visits.
Common questions
Accreditation, in plain terms
ISO 15189 is the accreditation standard for medical and clinical laboratories, covering the examination of patient samples. ISO/IEC 17025 is the standard for general testing and calibration laboratories. Some laboratories hold both, depending on the scope of work they carry out.
A UKAS mock audit is a full rehearsal of the real UKAS assessment, carried out before the official visit. It surfaces non-conformances against the applicable standard so they can be corrected in advance, which reduces the risk of findings during the actual assessment.
When a company outsources testing or trial work, it remains responsible for the quality of that work. A supplier audit provides independent assurance that the contracted laboratory operates to the required standard, delivered as a formal report with corrective actions tracked to closure.
Both. Documentation review, gap analysis, and much of the preparation can be handled remotely. Mock audits, supplier audits, and UKAS assessment support are typically carried out on-site, anywhere in the UK.
Start here
Request a call
Tell us your standard, your current accreditation status, and your target assessment date. You'll get a scoped proposal, not a sales pitch.