ISO 15189 forms, logs and QC sheet templates
All 125 forms, logs, QC sheets and checklists from the LabToolkit Pro quality-management set, grouped by the procedure they belong to. Each is mapped to its ISO 15189:2022 clause and available in the template pack or as a live record in the app.
Quality Policy and Objectives PD01 · ISO 15189 5.5, 8.9
Communication and Meetings PR01 · ISO 15189 4.3, 6.2, 7.2.2, 8.4
Control of Documents PR02 · ISO 15189 8.3, 8.4
Service Agreements PR03 · ISO 15189 6.7
Referral Laboratories and Consultants PR04 · ISO 15189 6.8, 7.2
Supplier and Service Evaluation PR05 · ISO 15189 6.8
Complaints and Feedback PR06 · ISO 15189 7.7, 8.6
- Customer Complaint FormFormPR06-F01 · As needed
- Complaints RegisterLogPR06-F02 · Monthly
- Customer Satisfaction Survey FormFormPR06-F03 · As needed
- Customer Survey ReportFormPR06-F04 · As needed
- Personnel Feedback FormFormPR06-F05 · As needed
- Personnel Feedback ReportFormPR06-F06 · As needed
- Staff Suggestion FormFormPR06-F07 · As needed
- Staff Suggestion LogLogPR06-F08 · Monthly
Nonconformity and Corrective Action PR07 · ISO 15189 5.6, 7.5, 8.5, 8.7, 8.8.2
- Nonconformity & Corrective Action FormFormPR07-F01 · As needed
- Corrective & Preventive Action (capa) FormFormPR07-F01 (CAPA-FORM) · As needed
- Nonconformity LogLogPR07-F02 · Monthly
- CAPA Register & Status TrackerLogPR07-F02 (CAPA-LOG) · Monthly
- 5-why Root Cause Analysis WorksheetFormPR07-F03a · As needed
- Fishbone / Ishikawa Cause Analysis WorksheetFormPR07-F03b · As needed
- Failure Mode & Effect Analysis (fmea) WorksheetFormPR07-F03c · As needed
- CAPA Effectiveness Review FormFormPR07-F04 · As needed
- Nonconformity Trend Analysis DashboardFormPR07-F05 · As needed
Control of Records PR08 · ISO 15189 8.4
Internal Audit PR09 · ISO 15189 6.2, 8.7, 8.8.3
- Internal Audit PlanFormPR09-F01 · As needed
- Individual Audit PlanFormPR09-F01 (AUDIT-PLAN) · As needed
- Annual Internal Audit ScheduleFormPR09-F01a · As needed
- Internal Audit Checklist — ISO 15189:2022FormPR09-F02 · As needed
- Internal Audit ReportFormPR09-F03 · As needed
- Internal Audit ReportFormPR09-F03 (AUDIT-REPORT) · As needed
- Audit NC & Corrective Action TrackerFormPR09-F04 · As needed
- Auditor Training & Competence AssessmentFormPR09-F05 · As needed
- Audit Closure & Follow-up RecordFormPR09-F06 · As needed
Risk Management and Improvement PR10 · ISO 15189 5.6, 8.5, 8.6
Management Review PR11 · ISO 15189 8.9
Personnel, Training and Competence PR12 · ISO 15189 4.1, 4.2, 6.2
- Personnel File ChecklistFormPR12-F01 · As needed
- Personnel Orientation ChecklistFormPR12-F02 · As needed
- Code of Ethics, Impartiality & Confidentiality DeclarationFormPR12-F03 · As needed
- Personnel Training & Continuous Professional Development PlanFormPR12-F04 · As needed
- Training Evaluation FormFormPR12-F05 · As needed
- Competence MatrixFormPR12-F06 · As needed
- General Competence Assessment FormFormPR12-F07a · As needed
- Management System Training and Competence FormFormPR12-F07b · As needed
- Departmental Technical Training and Competency Assessment (template for F07c–F07i)FormPR12-F07c · As needed
- Competency Assessment FormFormPR12-F08 · As needed
- Personnel Authorization MatrixFormPR12-F09 · As needed
- Authorised Signatures & Initials LogLogPR12-F10 · Monthly
- Work ScheduleFormPR12-F11a · As needed
- Departmental Duty RosterFormPR12-F11b · As needed
- On-call RosterFormPR12-F11c · As needed
- Personnel Replacement FormFormPR12-F12 · As needed
Emergency Preparedness PR13 · ISO 15189 7.8
Result Release and Critical Results PR14 · ISO 15189 7.4.1
Facilities and Environment PR15 · ISO 15189 6.3, 6.4, 6.6
- Refrigerator Temperature Monitoring LogLogPR15-F01a · Daily
- Freezer (–20 °c) Temperature Monitoring LogLogPR15-F01b · Daily
- Freezer (–80 °c) Temperature Monitoring LogLogPR15-F01c · Daily
- Incubator Temperature Monitoring LogLogPR15-F01d · Daily
- Room Temperature Monitoring LogLogPR15-F01e · Daily
- Water Bath Temperature Monitoring LogLogPR15-F01f · Daily
- Cleaning & Housekeeping LogLogPR15-F02 · Monthly
- Waste Disposal RecordLogPR15-F03 · Monthly
Equipment and Calibration PR16 · ISO 15189 6.2, 6.4, 6.5
- Equipment Inventory ListLogPR16-F01 · Monthly
- Equipment Operating ListFormPR16-F02 · As needed
- Equipment Decontamination FormChecklistPR16-F03 · As needed
- Equipment Maintenance & Occurrence LogLogPR16-F04 · Monthly
- Calibration Certificate Review FormChecklistPR16-F05 · As needed
- Interpolation CalculatorQc sheetPR16-F06 · As needed
Laboratory Information Management PR17 · ISO 15189 7.6
Reagents and Consumables PR18 · ISO 15189 6.6
Lot-to-Lot Verification PR19 · ISO 15189 6.6.3
Pre-examination and Sample Handling PR20 · ISO 15189 7.2, 7.4.2
- Specimen Acceptance Criteria (reference Card)FormPR20-F01 · As needed
- Sample Rejection LogLogPR20-F02 · Monthly
- Oral Request FormFormPR20-F03 · As needed
- Sample Acceptance Exceptions LogLogPR20-F04 · Monthly
- Sample Retention ScheduleFormPR20-F05 · As needed
- Sample Requirements, Transport Systems and Method Review FormFormPR20-F06 · As needed
Method Verification PR21 · ISO 15189 7.3.2
- Quantitative Method Verification PlanQc sheetPR21-F01a · As needed
- Qualitative Method Verification PlanQc sheetPR21-F01b · As needed
- Quantitative Method Verification ReportQc sheetPR21-F02a · As needed
- Qualitative Method Verification ReportQc sheetPR21-F02b · As needed
- Precision, Linearity & Accuracy WorksheetFormPR21-F03 · As needed
Measurement Uncertainty PR22 · ISO 15189 7.3.4
Internal Quality Control PR23 · ISO 15189 7.3.7.2
- IQC Frequency Determination FormFormPR23-F01 · As needed
- In-house IQC Preparation LogLogPR23-F02 · Monthly
- IQC Statistical Tool — Levey-jennings Chart SetupQc sheetPR23-F03 · As needed
- IQC Daily LogLogPR23-F04 · Daily
- CV Calculator — Alternative IQC MethodFormPR23-F05 · As needed
- Levey-Jennings chart & Westgard multirule monitorQc sheetPR23-T01 · As needed
- Sigma metric & QC strategy plannerQc sheetPR23-T02 · As needed