AuditsCompliance-in-a-Box: The Startup Guide to Audit-Ready DocsSVSid Varma · 12 min readFor quality managers and laboratory directors at medical laboratories accredited to ISO 15189:2022. What the standard asks to be documented, and what assessors sample.
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Checked against primary sources on 18 October 2026.
Medical laboratories, including point-of-care testing, that choose accreditation to show quality and competence to clinicians, patients, payers and regulators.
Accreditation bodies; in the US the CAP 15189 program, among others; a CLIA certificate is still required for US patient testing
Initial accreditation assessment, then periodic surveillance and reassessment; CAP 15189 runs a three-year accreditation cycle with remote and on-site assessments
ISO 15189:2022 (Edition 4), replacing ISO 15189:2012 and ISO 22870:2016, 2022-12-06. Paid standard (CHF 225 for English PDF + ePub or paper, per iso.org).
| Date | What happens | Status |
|---|---|---|
| 2025-12-06 | End of the three-year transition from ISO 15189:2012 to ISO 15189:2022 (ILAC Resolution GA 26.08) | Done |
| 2026-01-01 | IAF and ILAC roles pass to Global Accreditation Cooperation Incorporated (Global ACI) | Done |
Each one needs an owner, an approval, and proof it reached the people it covers.
Clause 8.2
Laboratory management documents objectives and policies addressing competence, quality and consistent operation, and ensures they are acknowledged and implemented at all levels.
Clause 4.1
The laboratory is structured and managed to safeguard impartiality, monitors threats including personnel relationships, and can show how each threat is removed or minimized.
Clause 6.2.2
Competence requirements are specified for each function influencing results, including education, qualification, training, retraining, technical knowledge, skills and experience.
Clause 6.2.3
Personnel are authorized for specific activities such as method selection, development, verification and validation, and the review, release and reporting of results.
Clause 8.3
The laboratory controls internal and external documents relating to the standard, so each is uniquely identified, approved, periodically reviewed and current at points of use.
Clause 8.4
Legible records demonstrate fulfillment of the standard, are created when each quality-affecting activity is performed, and amendments stay traceable to the original entries.
Citations are to the standard or regulation; wording is ours.
What reviewers sample about these documents and the people they cover.
Assessors check that only authorized staff select and verify methods and review, release and report results, and ask to see the authorization record for named individuals.
For sampled staff, assessors review competence requirements, position descriptions, training and retraining, authorization and competence monitoring records.
Assessors compare documents at workstations and in point-of-care settings with the controlled versions and check approval, review dates and removal of obsolete copies.
Assessors ask how threats to impartiality are monitored, and look for evidence that objectives and policies are acknowledged and implemented at all levels.
Write each policy, send it through approval, and send it to the people it covers. Each acknowledgment is recorded by name, with the version, the date and the time.
When a policy changes, the new version is approved, its Editor sends it out again, and everyone it applies to is asked again. Export the record as a PDF or CSV, or give a reviewer Viewer access to the documents their tags allow.
Need help with the rest of ISO 15189? Find a consultant for your standard (opens in a new tab).
Your region’s laws, the standards your customers ask for, and your own house rules. Write each one as a policy, approve it, and send it to the people it covers.
ILAC Resolution GA 26.08 set a three-year transition from publication, which ended in December 2025. After that, accreditation to the 2012 edition is no longer recognized under the international arrangement.
Yes. The 2022 edition applies to point-of-care testing and replaced ISO 22870:2016, which iso.org lists as withdrawn.
CMS regulates US laboratory testing on human specimens through CLIA, and laboratories need a CLIA certificate to test patient specimens. ISO 15189 accreditation, such as through CAP 15189, is an additional quality and competence program.
Clause 8.2 asks management to ensure objectives and policies are acknowledged and implemented at all levels of the laboratory. The standard leaves the evidence to the laboratory, and assessors typically look at communication and training records alongside staff interviews.
CAP notes that risk management has greater emphasis throughout the 2022 edition, with particular focus on risk to patients. The management system clauses also include actions to address risks and opportunities.
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