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ISO 15189:2022 Cl. 8.8 · NABL

ISO 15189:2022 internal audit pack generation tool

Internal audit is a standing ISO 15189:2022 requirement. QCnomics turns your live quality data into a structured internal-audit pack — checklist, evidence, findings and CAPA — instead of assembling it by hand before every assessment.

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What an internal audit pack contains

A complete ISO 15189:2022 internal audit pack covers the full standard, not just one clause. It includes an audit plan and scope, a clause-by-clause checklist, objective evidence for each requirement, documented findings, non-conformities graded by risk, corrective-action (CAPA) records with root-cause analysis, and management-review linkage.

Why generate it from live data

Hand-built audit files go stale between assessments. Because QCnomics already holds your IQC, EQA, method validation, equipment maintenance, document control and CAPA records, it can assemble the audit pack from current data — so the evidence an assessor sees matches what the lab actually did.

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Frequently asked questions

How often is internal audit required under ISO 15189:2022?

Labs must conduct internal audits at planned intervals (commonly annually across the full standard, or by rolling programme) to confirm the quality system conforms and is effective.

Does QCnomics cover the whole standard or just QC?

The internal audit module renders the complete ISO 15189:2022 clause checklist, with evidence capture and CAPA — not only the quality-control clauses.

Can findings be tracked to closure?

Yes. Non-conformities are logged with root-cause analysis and linked corrective/preventive actions, tracked to closure with a full audit trail for assessors.

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Clinical-grade internal quality control and ISO 15189:2022 compliance in one platform.

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