Labs, Inspection & Healthcare
Laboratories, inspection bodies and product certification bodies are accredited, not certified. Accreditation confirms technical competence and impartiality, and is assessed by a national accreditation body. We prepare you for it.
Start from the service you provide
Each standard is assessed by a national accreditation body for a defined scope of activities.
Competence of testing, calibration and sampling laboratories.
ISO/IEC 17025 → Medical laboratories ISO 15189 ISO 15189:2022Quality and competence of medical laboratories, including POCT.
ISO 15189 → Inspection ISO/IEC 17020 ISO/IEC 17020:2026Impartial, competent inspection, with transition by March 2029.
ISO/IEC 17020 → Product certification ISO/IEC 17065 ISO/IEC 17065:2012Bodies certifying products, processes and services.
ISO/IEC 17065 →Side by side
| Standard | For | Edition | Who decides | Typical engagement |
|---|---|---|---|---|
| ISO/IEC 17025 | Testing and calibration laboratories | 2017 | National accreditation body | 6 to 12 months |
| ISO 15189 | Medical laboratories | 2022 | National accreditation body | 6 to 12 months |
| ISO/IEC 17020 | Inspection bodies | 2026 | National accreditation body | 6 to 12 months |
| ISO/IEC 17065 | Product certification bodies | 2012 | National accreditation body | 6 to 12 months |
One methodology to accreditation
Delivered by registered lead auditors with hands-on sector experience.
- AssessGap assessment, scope and roadmap
- DesignProcesses, risks and documented information
- ImplementProcesses embedded on the ground
- TrainAwareness to internal auditor competence
- VerifyInternal audit, management review, mock audit
- Certify & sustainCertification audit support, then surveillance
A quality system that supports accreditation.
Laboratories and inspection bodies with ISO 9001 can use Option B management system requirements, so one system serves both.
Laboratory and inspection training
CQI/IRCA Approved Training Partner. In-house, public, virtual or hybrid.
- ISO/IEC 17025: Awareness, Implementer and Internal Auditor
- Measurement uncertainty and method validation workshops
- In-house ISO/IEC 17020:2026 and ISO 15189:2022 transition briefings
Accreditation FAQ
Does AEC accredit organisations?
No. Accreditation is granted by national accreditation bodies such as UKAS, DAkkS or PNAC. AEC prepares your organisation for that assessment.
What is the difference between accreditation and certification?
Certification bodies certify management systems or products. Accreditation bodies assess laboratories, inspection bodies and certification bodies for competence and impartiality.
What changed recently?
ISO 15189:2022 is now the only accepted edition, and ISO/IEC 17020:2026 was published in March 2026 with a transition to March 2029.
Is accreditation recognised internationally?
Yes, through the Global ACI mutual recognition arrangement, which brings together national accreditation bodies worldwide.
Plan your accreditation
Tell us your services, scope and current processes. We reply with a proposal covering gap assessment, technical records and accreditation readiness.
Accreditation decisions are made by national accreditation bodies. AEC prepares organisations for accreditation and does not guarantee outcomes.