Internal Audit Checklist — ISO 15189:2022 template
A form in the Internal Audit procedure (PR09), mapped to ISO 15189:2022 clause 8.8.3. Fill it in whenever the task occurs. Used by the quality-management team.
FormISO 15189 · 8.8.3As needed
Calculated automaticallyRed = outside limits
Your LaboratoryInternal Audit Checklist — ISO 15189:2022 | YL-QM-FRM-09-F02 v1.0
Record: Internal Audit Checklist — ISO 15189:2022 — October 2026
Audit RefIA-26-001
Date2026-10-01
Section AuditedHaematology
AuditorR. Naidoo
RATING KEY: C = Conform NC = Nonconformity OFI = Opportunity for Improvement NA = Not Applicable
| No. | Cl. | Audit Question / Requirement | Rating (C/NC/OFI/NA) | Objective Evidence | Finding / Observation | NC Ref | OFI Ref | Initials | Follow Up? |
|---|---|---|---|---|---|---|---|---|---|
| 4–5 General & Structural | |||||||||
| 1 | 4.1 | Is the laboratory scope documented and current? | C | Within limits | Within limits | NC-26-001 | REF-26-001 | TM | Y |
| 2 | 4.1 | Has impartiality been formally assessed? | C | NC-26-002 | REF-26-002 | RN | Y | ||
| 3 | 4.2 | Is there a confidentiality policy and is it followed? | C | NC-26-003 | REF-26-003 | SD | Y | ||
| 4 | 5.1 | Is an up-to-date organisational chart available? | NC | Within limits | Within limits | NC-26-004 | REF-26-004 | AM | Y |
| 5 | 5.1 | Are roles, responsibilities and authorities defined? | C | NC-26-005 | REF-26-005 | LB | Y | ||
| 6 | 5.1 | Is there a designated Lab Director with appropriate qualifications? | C | NC-26-006 | REF-26-006 | KO | Y | ||
| 7 | 5.2 | Is a Quality Officer / Quality Function clearly assigned? | C | Within limits | Within limits | NC-26-007 | REF-26-007 | TM | Y |
| 6 Resource Requirements | |||||||||
| 8 | 6.2 | Are staff qualifications appropriate for their roles? | C | NC-26-008 | REF-26-008 | RN | Y | ||
| 9 | 6.2 | Is a formal orientation conducted for all new staff? | C | NC-26-009 | REF-26-009 | SD | Y | ||
| 10 | 6.2 | Are annual competency assessments conducted for all staff? | C | Within limits | Within limits | NC-26-010 | REF-26-010 | AM | Y |
% Conform90.0
… 47 more rows continue on the next page
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Completed by | |||
| Reviewed by |
Shaded cells are calculated automatically. Values in red are outside their limits. † marks a corrected value (see Corrections).
Controlled document. Printed copies are uncontrolled unless stamped.Page 1
A4 landscape · first page · showing 10 of 57 rowsExactly as LabToolkit Pro prints it — with your logo and colours
What it records
- Cl.
- Audit Question / Requirement
- Rating (C/NC/OFI/NA)
- Objective Evidence
- Finding / Observation
- NC Ref
- OFI Ref
- Initials
- Follow Up?
Instructions on the form
- RATING KEY: C = Conform NC = Nonconformity OFI = Opportunity for Improvement NA = Not Applicable
Sign-off
- Completed by
- Reviewed by
Related templates
- Internal Audit Plan (PR09-F01)
- Individual Audit Plan (PR09-F01 (AUDIT-PLAN))
- Annual Internal Audit Schedule (PR09-F01a)
- Internal Audit Report (PR09-F03)
- Internal Audit Report (PR09-F03 (AUDIT-REPORT))
- Audit NC & Corrective Action Tracker (PR09-F04)
- Auditor Training & Competence Assessment (PR09-F05)
- Audit Closure & Follow-up Record (PR09-F06)
- Guide: ISO 15189 documentation checklist
Clause references are to ISO 15189:2022; check them against your licensed copy of the standard.