ISO 15189:2022
Medical Laboratories – Requirements for Quality and Competence
INTERNAL AUDIT CHECKLIST
Laboratory Name:
Audit Date:
Lead Auditor:
Audit Team:
Scope of Audit:
Document Ref:
Version:
1.0
GRADING KEY
C
Compliant
NC
Non-Conformance
OFI
Opportunity for Improvement
NA
Not Applicable
P
Partial
NR
Not Reviewed
SECTION A – MANAGEMENT REQUIREMENTS (Clauses 4.1 – 4.15)
Clause 4.1 – 4.2 | Organisational Status, Quality Management System & Policies
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
4.1.1
Is the laboratory legally identifiable and responsible for its activities?
Legal registration, license documents
4.1.2
Does the laboratory define and document its scope of examination?
Scope statement, accreditation certificate
4.1.3
Is there documented evidence of management commitment to quality?
Quality policy signed by management
4.1.4
Are activities performed to avoid conflicts of interest that could adversely influence quality?
COI declarations, organisational chart
4.1.5
Does the laboratory have sufficient resources (staff, equipment, space) to meet requirements?
Resource plan, staffing records
4.2.1
Is there a documented quality management system covering all requirements of ISO 15189?
QMS manual / policy document
4.2.2
Are quality policies and objectives established, communicated and understood by all staff?
Policy board/intranet, staff meeting minutes
4.2.3
Is there a designated Quality Manager with defined responsibilities?
Job description, appointment letter
Clause 4.3 – 4.15 | Document Control, Agreements, Non-Conformance & Improvement
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
4.3
Does the laboratory manage document control (issuance, review, approval, distribution)?
Document control procedure, master document list
4.4
Is there a documented service agreements process (request, patient information, clinical relevance)?
Service agreements, user handbook, clinical consultation records
4.5
Is there a documented process for using referral laboratories including criteria and performance monitoring?
Referral lab list, referral policy, referral lab performance records
4.6
Are external services and supplies evaluated and selected based on defined criteria?
Approved supplier list, supplier evaluation records
4.7
Is advisory service provided to users (clinical interpretation, test selection)?
Advisory service policy, consultation records
4.8
Are complaints received, investigated and resolved with records maintained?
Complaints policy, complaints register, resolution records
4.9
Is there a documented non-conformance management process with root cause analysis and CAPA?
NC register, CAPA log, trend analysis records
4.10
Is there a documented corrective action process ensuring effectiveness of actions taken?
CAPA procedure, effectiveness review records
4.11
Is there a documented preventive action process for continual improvement?
Preventive action log, improvement register
4.12
Are continual improvement activities tracked and evaluated for effectiveness?
Improvement programme records, quality indicators
4.13
Are quality and technical records retained per a defined retention schedule?
Records retention schedule, archived records
4.14
Are internal audits conducted at planned intervals covering all QMS elements?
Internal audit programme, audit reports, finding logs
4.15
Is a management review conducted at defined intervals with documented outcomes?
Management review agenda/minutes, action plans
SECTION B – TECHNICAL REQUIREMENTS (Clause 5)
Clause 5.1 | Personnel
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
5.1.1
Is there a documented personnel policy defining qualifications, training and competency?
HR policy, personnel files
5.1.2
Are job descriptions available for all positions in the laboratory?
Job descriptions for each role
5.1.3
Is there a documented training programme for new and existing staff?
Training programme records
5.1.4
Is competency of all staff assessed at defined intervals (minimum annually)?
Competency assessment records, sign-off sheets
5.1.5
Are education, qualification and experience records maintained for all staff?
Personnel files, CVs, certificates
5.1.6
Are continuing education/professional development activities documented?
CPD records, course certificates
5.1.7
Is there a process for identifying and authorising staff for specific examination activities?
Authorisation records, scope of practice list
Clause 5.2 | Accommodation and Environmental Conditions
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
5.2.1
Are accommodation and environmental conditions appropriate for laboratory activities?
Environmental monitoring logs, floor plan
5.2.2
Are temperature, humidity, lighting and noise levels controlled and documented?
Environmental control records
5.2.3
Are separate areas provided for incompatible activities (e.g., pre-analytical, post-analytical)?
Floor plan, SOPs for work area control
5.2.4
Is there controlled access to areas that may affect examination quality?
Access control records, visitor log
5.2.5
Are housekeeping and cleanliness standards defined and maintained?
Cleaning schedule, housekeeping SOP
5.2.6
Is waste disposal managed in accordance with applicable regulations?
Waste management SOP, disposal contracts
Clause 5.3 | Laboratory Equipment, Reagents and Consumables
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
5.3.1
Is there an inventory of all laboratory equipment?
Equipment inventory/register
5.3.2
Are equipment selection, purchase and acceptance criteria defined?
Equipment procurement policy, acceptance testing records
5.3.3
Is equipment used only by authorised and trained personnel?
Equipment authorisation records, training logs
5.3.4
Are calibration and maintenance schedules established and followed?
Calibration certificates, maintenance logs
5.3.5
Are calibration standards traceable to national/international measurement standards?
Metrological traceability certificates
5.3.6
Are there documented procedures for handling non-conforming equipment?
Non-conformance SOP, equipment quarantine records
5.3.7
Is there a documented reagent and consumable management process?
Reagent inventory, acceptance criteria records
5.3.8
Are instructions for use (IFU) and manuals retained for all equipment?
IFU files, equipment manuals
Clause 5.4 | Pre-Examination Processes
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
5.4.1
Are pre-examination processes clearly defined and documented?
Pre-examination SOPs
5.4.2
Are criteria for specimen acceptance/rejection defined and communicated to users?
Acceptance/rejection criteria policy, user handbook
5.4.3
Are procedures for primary sample collection documented and available at the point of collection?
Phlebotomy manual, collection guidelines
5.4.4
Are instructions for patient preparation and sample labelling clearly documented?
Patient preparation guides, labelling policy
5.4.5
Is there a documented process for specimen receipt, registration and tracking?
LIS records, specimen receipt log
5.4.6
Are transportation conditions (time, temperature) defined and monitored?
Transport SOP, cold-chain monitoring records
5.4.7
Are samples stored appropriately prior to examination?
Storage temperature logs, sample storage SOP
Clause 5.5 | Examination Processes
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
5.5.1
Are validated/verified examination procedures in use for all examinations?
Validation/verification reports
5.5.2
Are examination procedures documented as SOPs (method, principle, reagents, calibration, QC, reference intervals, interpretation)?
SOPs for all examination methods
5.5.3
Are biological reference intervals (RI) established and reviewed periodically?
RI establishment records, literature references
5.5.4
Is there a documented process for selecting reference measurement procedures?
Reference method selection records
5.5.5
Are examination records including raw data retained per retention policy?
Examination records, raw data logs in LIS
5.5.6
Are uncertainty of measurement values estimated for all key examinations?
Uncertainty of measurement calculations
5.5.7
Is there a process for handling samples with insufficient quality (haemolysis, lipaemia, etc.)?
Sample quality assessment SOP
Clause 5.6 | Ensuring Quality of Examination Results (IQC & EQA)
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
5.6.1
Is there a documented internal quality control (IQC) programme?
IQC policy, Levey-Jennings charts
5.6.2
Are IQC materials used at clinically relevant decision levels?
IQC selection records
5.6.3
Are IQC results reviewed by authorised personnel before results are released?
IQC review records, authorisation logs
5.6.4
Are IQC failure rules (e.g., Westgard rules) defined and applied?
QC rules document, action logs
5.6.5
Does the laboratory participate in external quality assessment (EQA/PT) schemes for all applicable examinations?
EQA enrolment certificates, EQA reports
5.6.6
Are EQA results reviewed and corrective actions taken where required?
EQA review records, corrective action log
5.6.7
Are inter-laboratory comparisons used where EQA is not available?
Comparison records, agreements
Clause 5.7 | Post-Examination Processes
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
5.7.1
Are post-examination processes including sample retention clearly documented?
Post-examination SOP, retention schedule
5.7.2
Is there a safe disposal process for samples after the retention period?
Disposal SOP, waste disposal records
Clause 5.8 | Reporting of Results
Ref
Requirement / Audit Question
Evidence / Documents Required
C / NC / NA
Finding
Notes / Comments
5.8.1
Are examination reports complete, accurate and formatted to meet requirements?
Report template, sample reports
5.8.2
Do reports include all required elements (patient ID, date/time, examinations, results, units, reference intervals, interpretation)?
Report checklist, sample reports
5.8.3
Are critical results communicated immediately to the requesting clinician and documented?
Critical value policy, notification records
5.8.4
Is there a process for amended or corrected reports that preserves the original?
Report amendment SOP, amended report examples
5.8.5
Is the turnaround time (TAT) monitored against defined targets?
TAT monitoring records, KPI reports
5.8.6
Are verbal results documented and followed by a written report?
Verbal result log policy
SECTION C – AUDIT SUMMARY & FINDINGS LOG
Use this section to record all findings raised during the audit.
Finding #
Clause Ref
Finding Description
Evidence Reviewed
Grading (NC/OFI/P)
Recommended Action
Target Date / Owner
01
02
03
04
05
06
07
08
Audit Statistics Summary
Category
Count
% of Total Checked
Total Checklist Items
Compliant (C)
Non-Conformances (NC)
Opportunities for Improvement (OFI)
Partial Compliance (P)
Not Applicable (NA)
Not Reviewed (NR)
Auditor Declaration & Signatures
Name
Role
Signature
Date
Lead Auditor
Technical Auditor
Quality Manager
Laboratory Director