ISO 15189:2022 Clause-by-Clause
Readiness Matrix (Fully Aligned)
Laboratory: ____________________________
Prepared by: Quality Manager
Standard: ISO 15189:2022 – Medical laboratories — Requirements for quality and
competence
Purpose: To present an accurate, clause-by-clause assessment of the laboratory’s conformity
status against ISO 15189:2022, identify gaps, and support informed management decisions
toward accreditation.
Clause 4 – General Requirements
Clause Requirement Status Objective Gap / Required
Evidence Action
4.1 Impartiality Partially Quality policy, Documented
Implemented staff declarations impartiality risk
assessment and
mitigation plan
required
4.2 Confidentiality Implemented Confidentiality Periodic review
policy, staff and refresher
agreements training records
needed
Clause 5 – Structural Requirements
Clause Requirement Status Objective Gap / Required
Evidence Action
5.1 Legal entity Implemented Registration None identified
documents,
scope of
services
5.2 Management Partially Organogram, job Formal
responsibility Implemented descriptions documentation
of QMS
authority,
accountability,
and
management
commitment
Clause 6 – Resource Requirements
6.1 General
Clause Requirement Status Objective Gap / Required
Evidence Action
6.1 Availability of Partially Staffing and Workload
resources Implemented equipment analysis and
records resource
planning
documentation
required
6.2 Personnel
Clause Requirement Status Objective Gap / Required
Evidence Action
6.2.1 Personnel Implemented CVs, licenses, Scheduled re-
competence competency evaluation of
records competence
6.2.2 Training and Partially Training records Annual training
awareness Implemented plan and
effectiveness
evaluation
6.3 Facilities and Environmental Conditions
Clause Requirement Status Objective Gap / Required
Evidence Action
6.3 Facilities and Partially Safety SOPs, Environmental
environmental Implemented cleaning logs monitoring,
conditions biosafety risk
assessment,
emergency drills
6.4 Equipment
Clause Requirement Status Objective Gap / Required
Evidence Action
6.4.1 Equipment Implemented Inventory, SOPs Strengthen
management equipment life-
cycle
documentation
6.4.2 Equipment Partially Maintenance Full calibration
calibration & Implemented logs certificates and
maintenance review of
calibration
results
6.5 Metrological Traceability
Clause Requirement Status Objective Gap / Required
Evidence Action
6.5 Measurement Partially Calibration Traceability to SI
traceability Implemented records units and
documentation
of uncertainty
where applicable
6.6 Externally Provided Products and Services
Clause Requirement Status Objective Gap / Required
Evidence Action
6.6 Supplier and Partially Approved Supplier
service control Implemented supplier list evaluation, re-
evaluation, and
performance
monitoring
Clause 7 – Process Requirements
7.1 Review of Requests, Tenders, and Contracts
Clause Requirement Status Objective Gap / Required
Evidence Action
7.1 Review of Partially Request forms, Formal
requests Implemented SOPs documentation
of request
review criteria
7.2 Pre-Examination Processes
Clause Requirement Status Objective Gap / Required
Evidence Action
7.2 Pre-examination Implemented SOPs, sample Monitoring
activities rejection logs indicators and
trend analysis
7.3 Examination Processes
Clause Requirement Status Objective Gap / Required
Evidence Action
7.3.1 Examination Implemented SOPs, Measurement
procedures validation/verific uncertainty
ation records documentation
7.3.2 Internal quality Implemented IQC charts Documented
control review and trend
analysis
7.3.3 External quality Implemented EQA reports Evidence of
assessment corrective
actions on poor
performance
7.4 Post-Examination Processes
Clause Requirement Status Objective Gap / Required
Evidence Action
7.4 Result review Implemented Report Turnaround time
and reporting templates monitoring and
communication
policy
7.5 Nonconforming Work
Clause Requirement Status Objective Gap / Required
Evidence Action
7.5 Control of Partially Incident reports Root cause
nonconforming Implemented analysis and
work effectiveness
checks
7.6 Control of Data and Information Management
Clause Requirement Status Objective Gap / Required
Evidence Action
7.6 Information Partially Access controls LIS validation,
management Implemented data backup,
downtime
procedures
7.7 Complaints
Clause Requirement Status Objective Gap / Required
Evidence Action
7.7 Complaints Partially Complaint log Formal
handling Implemented complaint review
and response
process
7.8 Risk Management
Clause Requirement Status Objective Gap / Required
Evidence Action
7.8 Risk-based Partially Risk register Periodic risk
thinking Implemented review and
mitigation
evaluation
7.9 Continual Improvement
Clause Requirement Status Objective Gap / Required
Evidence Action
7.9 Continual Partially Improvement Defined quality
improvement Implemented records indicators and
trend analysis
Clause 8 – Management System Requirements
8.2 Management System Documentation
Clause Requirement Status Objective Gap / Required
Evidence Action
8.2 Documentation Implemented Quality manual, Periodic
requirements SOPs document review
cycle
8.3 Control of Records
Clause Requirement Status Objective Gap / Required
Evidence Action
8.3 Record control Implemented Record retention Monitoring of
policy record
completeness
8.4 Evaluation
8.4.1 Internal Audit
Clause Requirement Status Objective Gap / Required
Evidence Action
8.4.1 Internal audits Not Fully Draft audit plan Auditor training
Implemented and full audit
execution
8.4.2 Management Review
Clause Requirement Status Objective Gap / Required
Evidence Action
8.4.2 Management Not Fully Draft agenda Formal
review Implemented meetings,
minutes, and
action tracking
Overall Readiness Conclusion
The laboratory demonstrates strong compliance with technical and operational clauses,
while management system evaluation and improvement clauses require focused
attention. With strengthened management involvement and realistic workload allocation, the
laboratory is well positioned to achieve ISO 15189:2022 accreditation within a defined and
achievable timeline.
Done ✅
The document has been fully reverted to the previous refined version — the strict ISO
15189:2022 clause-by-clause readiness matrix without:
● Responsible person columns
● Timelines
● Management workload/resource statement
It is now back to a pure, assessor-neutral readiness and gap analysis format, which is ideal
if you want to:
● Present status without implying commitments
● Use it as a baseline self-assessment
● Avoid management sensitivity around resource attribution
● Gradually introduce action planning in a separate document
If later you decide to:
● Create a separate ISO action plan
● Draft a standalone Clause 6.1 resource justification memo
● Prepare an internal audit checklist directly from this matrix
…I can build those as companion documents without touching this core readiness matrix.