ISO 15189:2022 · Section 8 · Management system requirements
Clause 8.8: Evaluations and internal audits
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What this clause is about
Evaluation gives the laboratory evidence about whether its processes meet expectations and work effectively. Combine routine quality indicators with internal audits and other appropriate reviews. Indicators reveal patterns over time, while audits examine how arrangements are implemented and why performance may differ from expectations. Neither should become a paperwork exercise performed only shortly before an external assessment.
Choose indicators that reflect important parts of the service, including pre-examination and post-examination activities. Define the measure, data source, collection method, review frequency and response when performance is unsatisfactory. Use denominators and categories that make interpretation meaningful. A count of rejected specimens tells little without knowing workload, reasons and collection settings. Review trends with the people able to change the process, and adjust measures when they no longer answer a useful question.
Plan internal audits using process importance, risk, previous findings and changes in the service. Ensure the programme covers the relevant laboratory activities and management arrangements over a justified period. Auditors need suitable competence and sufficient objectivity; avoid having someone assess only their own work. Define each audit's scope, criteria and methods, then gather evidence through observation, record sampling and staff discussion. Follow a specimen or decision across handoffs rather than checking isolated documents alone.
Report findings clearly enough that responsible staff understand the evidence and the unmet expectation. Assign actions, communicate results to appropriate personnel and verify follow-up. Review the audit programme itself when it repeatedly misses significant weaknesses. LabToolkit Pro can support audit checklists, forms, QC charts and action records, but the laboratory must choose representative evidence, interpret indicators correctly and ensure evaluations lead to decisions that improve actual performance.
What assessors typically ask to see
- Why were the selected quality indicators chosen, and how do they represent important risks across the complete laboratory pathway?
- How are indicator definitions, data quality, review frequency and responses to unsatisfactory performance established and maintained?
- How does the audit programme use risk, process importance, previous findings and service changes to set priorities?
- What demonstrates auditor competence and sufficient objectivity when reviewing activities in a small or highly specialized laboratory?
- Can an audit trail show evidence collection, clear findings, assigned actions and verification that follow-up was effective?
Documents and records that usually provide evidence
- Evaluation plan identifying quality indicators, their purpose, data sources, calculation rules, review arrangements and responsible owners.
- Indicator reviews showing interpreted trends, relevant workload context, decisions made and follow-up when expectations were not met.
- Internal audit programme covering relevant activities with priorities informed by risks, previous performance and significant changes.
- Auditor competence records and allocation arrangements addressing technical understanding, audit skills and conflicts with work being assessed.
- Audit plans and reports documenting scope, criteria, sampling, objective evidence, findings and communication to responsible personnel.
- Follow-up records connecting audit findings with corrections, corrective actions where appropriate and evidence supporting closure.
Ready-made forms mapped to clause 8.8: Nonconformity Trend Analysis Dashboard, Internal Audit Plan, Individual Audit Plan, Annual Internal Audit Schedule, Internal Audit Checklist — ISO 15189:2022, Internal Audit Report, Internal Audit Report, Audit NC & Corrective Action Tracker, Auditor Training & Competence Assessment, Audit Closure & Follow-up Record, Quality Indicators Plan Form, Quality Indicators Monitoring Dashboard.
Common findings to avoid
- Collecting indicator data for many months without interpreting trends or assigning action when performance is persistently poor.
- Auditing only whether procedures exist while overlooking whether staff follow them and whether the resulting process is effective.
- Repeating an identical audit schedule despite major service changes, recurring incidents or high-risk activities receiving little attention.
- Closing audit findings after accepting an action promise without checking implementation or effectiveness when required.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 8.8 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 8.8 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Must every activity be audited on the same schedule?
Use a planned programme that achieves appropriate coverage while giving greater attention to significant risks, weak performance and changes. Explain the scheduling basis and revise it when evidence shows that priorities have shifted.
Can staff audit a process they understand technically?
Technical understanding is valuable, but objectivity must be protected. Avoid assessing only their own activities. Cross-auditing, paired auditors or suitable external support can help small teams obtain both relevant expertise and independent scrutiny.
Are quality control charts sufficient evaluation?
They provide important examination-performance evidence but do not cover the entire service. Include measures and audits addressing identification, collection, transport, reporting, communication and management processes according to laboratory risks and objectives.
Check the exact requirement in your licensed copy of the standard.
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