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ISO 15189:2022 checklist for medical laboratories (after the transition)

Published 15 October 2026 · Reviewed against the sources below

ISO 15189:2022 was published in December 2022. UKAS set 6 December 2025 as the date after which accreditation to the 2012 version would no longer be valid, and in December 2025 it confirmed that the transition programme was complete. So if your laboratory is accredited today, it is accredited to the 2022 edition. If you're applying for the first time, you'll be assessed against it.

This checklist covers what assessors expect to see under each main clause. It gives clause numbers and titles only. It does not reproduce the standard, so you'll need your own licensed copy from ISO or BSI to read the requirements in full.

What changed from 2012, in brief

New structure. Clauses 4 to 8 now follow the layout of ISO/IEC 17025:2017: general, structural, resource, process and management system requirements.
Risk to patients is the focus. Risk management runs through the standard, with a specific clause on it (5.6) and actions to address risks and opportunities (8.5).
Point-of-care testing is included. POCT requirements are in Annex A, which replaces the separate ISO 22870. UKAS has updated its POCT training to reflect this.
Patient-focused requirements sit up front in clause 4.3, alongside impartiality (4.1) and confidentiality (4.2).

Checklist by clause

4 General requirements

An impartiality policy, an impartiality risk assessment and declarations of interest (4.1)
Confidentiality arrangements for patient information, including what you tell users about release of information (4.2)
Documented requirements regarding patients, such as access, information, consent and feedback (4.3)

5 Structural and governance requirements

Legal entity and a named laboratory director with their responsibilities defined (5.1, 5.2)
A defined scope of laboratory activities, including referral work (5.3)
An organisation chart and authorities (5.4), quality objectives and policies (5.5)
A risk management process that covers patient harm (5.6)

6 Resource requirements

Competence records, training, authorisation and ongoing competence assessment for every role (6.2)
Monitoring of facilities and environmental conditions (6.3)
Equipment records, maintenance, calibration and metrological traceability (6.4, 6.5)
Reagent and consumable acceptance testing and inventory (6.6)
Service agreements with users (6.7) and control of external providers, including referral laboratories (6.8)

7 Process requirements

User information, request forms, sample collection instructions and sample acceptance and rejection criteria (7.2)
Verification and validation of examination methods, measurement uncertainty, reference intervals, and IQC and EQA arrangements (7.3)
Report content, review and release, critical result communication and amended reports (7.4)
Nonconforming work (7.5), data and information management, including LIMS validation (7.6), complaints (7.7) and continuity and emergency planning (7.8)

8 Management system requirements

Control of documents and records (8.2 to 8.4)
Improvement, nonconformity and corrective action (8.6, 8.7)
Evaluations: internal audit and user feedback (8.8)
Management review, with inputs and outputs recorded (8.9)

Annex A Point-of-care testing (if you oversee POCT)

POCT governance, training and competence of non-laboratory operators, IQC/EQA and connectivity

Tips for your next UKAS visit

Keep a current gap analysis that cross-references each clause to your evidence. UKAS asked for this during the transition, and it is still the quickest way to show an assessor around your system.
Make sure records show the system working, such as completed audits, reviewed IQC and closed corrective actions, rather than documents alone.
If you also hold CQC registration, link your laboratory quality system to CQC's key questions so that one set of evidence serves both.

The Wardour Lab pack provides an ISO 15189:2022-structured quality manual, procedures and Excel records mapped to the clauses above. It gives clause references only and doesn't include the standard's text. Buying it doesn't guarantee UKAS accreditation.