ISO 15189 Ready · The library
184 documents, English and Georgian — completely free, open to everyone
See every code and title, read every sample — then download the complete English pack or the complete Georgian pack, no payment and no account required.
35 policies · 20 procedures · 91 SOPs · 28 forms, registers, matrices · 10 job descriptions · 153 universal, the rest by discipline
The line that never moves. ASF prepares medical laboratories for ISO 15189. ASF does not accredit them. ISO 15189 accreditation is granted by a national accreditation body — in Georgia the Georgian Accreditation Centre; elsewhere the ILAC-recognised body of your country — after its own assessment. ASF takes no commission and recommends none. ISO 15189 Ready is a separate product from ISO 9001 Ready and from ASF healthcare accreditation.
Every policy, procedure and SOP carries a document-control block, purpose, scope, responsibilities, the steps, the records it produces and its references; every form and register carries the instruction for when and by whom it is completed and a filled-in example row; every job description follows clause 6.2 — ISO 15189:2022, CLSI, WHO and the national regulation. The structure, the samples and the complete pack are all free, in English and Georgian — download, print, edit and reuse them for your laboratory however you need.
Free
The complete pack — all 184 documents, English and Georgian. No payment, no login, no catch.
Documents per discipline module
153 of the 184 documents are universal and apply to every laboratory regardless of section. The remaining 31 are discipline-specific SOPs and job descriptions, included only when the corresponding section exists — shown here by module.
Clinical biochemistry
8
Hematology
7
Coagulation
6
Immunology / immunoassay
5
Urinalysis
5
Inside the bench — what the SOPs govern
Photo: Adam Bezer / Unsplash
Photo: Adam Bezer / Unsplash
Governance — Document Control & Risk Management · 7
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-P-01 | Quality Policy | Policy | Always | Download sample (EN, .docx) → |
| LAB-P-02 | Document Control Policy | Policy | Always | in the pack |
| LAB-P-03 | Records Management and Retention Policy | Policy | Always | in the pack |
| LAB-P-04 | Risk Management Policy | Policy | Always | in the pack |
| LAB-PR-01 | Document Control Procedure | Procedure | Always | in the pack |
| LAB-PR-02 | Records Control and Retention Procedure | Procedure | Always | in the pack |
| LAB-PR-03 | Risk Assessment Procedure | Procedure | Always | in the pack |
Management Requirements — Audit, CAPA, Review, Complaints, Impartiality · 16
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-P-05 | Internal Audit Policy | Policy | Always | in the pack |
| LAB-P-06 | Nonconformity, Correction and CAPA Policy | Policy | Always | in the pack |
| LAB-P-07 | Management Review Policy | Policy | Always | in the pack |
| LAB-P-10 | Data Protection and Confidentiality Policy | Policy | Always | in the pack |
| LAB-P-23 | Complaints Management Policy | Policy | Always | in the pack |
| LAB-P-24 | Ethics and Impartiality Policy | Policy | Always | in the pack |
| LAB-P-25 | Communication Policy | Policy | Always | in the pack |
| LAB-PR-04 | Internal Audit Conduct Procedure | Procedure | Always | Download sample (EN, .docx) → |
| LAB-PR-05 | CAPA Process Management Procedure | Procedure | Always | in the pack |
| LAB-PR-06 | Management Review Procedure | Procedure | Always | in the pack |
| LAB-SOP-21 | Nonconforming Work, Hold and Release, and CAPA | SOP | Always | in the pack |
| LAB-SOP-CUST-01 | Complaint Intake, Investigation and Response | SOP | Always | in the pack |
| LAB-SOP-CUST-02 | Client Feedback and Satisfaction Assessment | SOP | Always | in the pack |
| LAB-SOP-HR-04 | Personnel Awareness: Impartiality and Confidentiality | SOP | Always | in the pack |
| LAB-SOP-PO-05 | Data Correction | SOP | Always | in the pack |
| LAB-SOP-PO-06 | Customer Communication | SOP | Always | in the pack |
Resources — Personnel · 8
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-P-08 | Personnel Competence Policy | Policy | Always | in the pack |
| LAB-P-09 | Training and Education Policy | Policy | Always | in the pack |
| LAB-P-31 | Personnel Health and Immunization Policy | Policy | Always | in the pack |
| LAB-PR-07 | Competency Assessment Procedure | Procedure | Always | in the pack |
| LAB-PR-08 | Training Planning and Delivery Procedure | Procedure | Always | in the pack |
| LAB-SOP-HR-01 | Competency Assessment | SOP | Always | in the pack |
| LAB-SOP-HR-02 | Training Delivery and Attendance Documentation | SOP | Always | in the pack |
| LAB-SOP-HR-03 | Personnel Health, Immunization and Exposure Management | SOP | Always | in the pack |
Resources — Equipment & Reagents · 18
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-P-18 | Equipment Management Policy | Policy | Always | in the pack |
| LAB-P-19 | Calibration, Verification and Traceability Policy | Policy | Always | in the pack |
| LAB-P-20 | Equipment Maintenance Policy | Policy | Always | in the pack |
| LAB-P-34 | Equipment Decommissioning Policy | Policy | Always | in the pack |
| LAB-PR-09 | Equipment Selection, Acquisition and Acceptance Procedure | Procedure | Always | in the pack |
| LAB-PR-10 | Equipment Calibration and Traceability Procedure | Procedure | Always | in the pack |
| LAB-PR-11 | Equipment Performance Verification Procedure | Procedure | Always | in the pack |
| LAB-SOP-A-05 | Calibration and Calibration Verification | SOP | Always | in the pack |
| LAB-SOP-A-09 | Reagent Receipt, Storage and Lot Verification | SOP | Always | in the pack |
| LAB-SOP-BIO-06 | Biochemistry — Reagent/Calibrator Receipt, Storage and Lot Verification | SOP | Clinical biochemistry | in the pack |
| LAB-SOP-BIO-07 | Biochemistry Equipment Maintenance and Malfunction Management | SOP | Clinical biochemistry | in the pack |
| LAB-SOP-EQ-01 | Equipment Receipt, Inventory and Acceptance | SOP | Always | in the pack |
| LAB-SOP-EQ-02 | Calibration Log Maintenance and Control | SOP | Always | in the pack |
| LAB-SOP-EQ-03 | Scheduled Maintenance | SOP | Always | in the pack |
| LAB-SOP-EQ-04 | Equipment Breakdown Management | SOP | Always | in the pack |
| LAB-SOP-EQ-06 | Equipment Decommissioning | SOP | Always | in the pack |
| LAB-SOP-IMM-04 | Immunology Reagent and Calibrator Lot Verification and Calibration | SOP | Immunology / immunoassay | in the pack |
| LAB-SOP-QC-02 | QC Material Receipt, Storage and Lot Change | SOP | Always | in the pack |
Resources — Facilities, Environment & Suppliers · 11
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-P-11 | IT and Information Security Policy | Policy | Always | in the pack |
| LAB-P-12 | Biosafety Policy | Policy | Always | in the pack |
| LAB-P-14 | Medical Waste Management Policy | Policy | Always | in the pack |
| LAB-P-21 | Environmental Conditions Monitoring Policy | Policy | Always | in the pack |
| LAB-P-22 | Supplier and External Services Management Policy | Policy | Always | in the pack |
| LAB-P-28 | Fire Safety Policy | Policy | Always | in the pack |
| LAB-PR-12 | Environmental Conditions Monitoring Procedure | Procedure | Always | in the pack |
| LAB-PR-13 | Cleaning and Disinfection Procedure | Procedure | Always | in the pack |
| LAB-PR-29 | Supplier Evaluation and Monitoring Procedure | Procedure | Always | in the pack |
| LAB-SOP-31 | Information Security: Passwords, Access and Logging | SOP | Always | in the pack |
| LAB-SOP-SF-07 | Facility Cleaning Schedule and Control | SOP | Always | in the pack |
Pre-Examination — Specimen Pathway · 18
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-P-16 | Specimen Management Policy | Policy | Always | in the pack |
| LAB-P-17 | Specimen Rejection Policy | Policy | Always | in the pack |
| LAB-PR-17 | Specimen Reception Procedure | Procedure | Always | in the pack |
| LAB-PR-18 | Specimen Rejection Procedure | Procedure | Always | in the pack |
| LAB-SOP-COAG-05 | Coagulation Specimen Acceptance and Rejection Criteria (Citrate Tubes) | SOP | Coagulation | in the pack |
| LAB-SOP-PA-01 | Patient Preparation | SOP | Always | in the pack |
| LAB-SOP-PA-02 | Specimen Collection | SOP | Always | in the pack |
| LAB-SOP-PA-03 | Specimen Labeling and Identification | SOP | Always | Download sample (EN, .docx) → |
| LAB-SOP-PA-04 | Specimen Packaging | SOP | Always | in the pack |
| LAB-SOP-PA-05 | Specimen Transportation | SOP | Always | in the pack |
| LAB-SOP-PA-06 | Specimen Reception at Laboratory | SOP | Always | in the pack |
| LAB-SOP-PA-07 | Specimen Rejection | SOP | Always | in the pack |
| LAB-SOP-PA-08 | Pre-Analytical Storage | SOP | Always | in the pack |
| LAB-SOP-PA-09 | Pre-Treatment: Centrifugation, Serum Separation and Division | SOP | Always | in the pack |
| LAB-SOP-PA-10 | Aliquoting and Secondary Container Identification | SOP | Always | in the pack |
| LAB-SOP-PA-11 | Specimen Destruction and Retention Completion | SOP | Always | in the pack |
| LAB-SOP-PA-12 | Chain of Custody (When Required) | SOP | Always | in the pack |
| LAB-SOP-UR-04 | Urine Specimen Acceptance and Rejection Criteria | SOP | Urinalysis | in the pack |
Examination — General Analytical · 14
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-P-30 | Laboratory Access Control Policy | Policy | Always | in the pack |
| LAB-P-36 | Analytical Method Validation Policy | Policy | Always | in the pack |
| LAB-P-37 | Quality Control (QC/IQC/EQA) Policy | Policy | Always | in the pack |
| LAB-P-43 | IT Downtime and Access Control Policy | Policy | Always | in the pack |
| LAB-PR-23 | QC/IQC/EQA System Management Procedure | Procedure | Always | in the pack |
| LAB-SOP-40-MU | Measurement Uncertainty (MU): Calculation and Application Rules | SOP | Always | in the pack |
| LAB-SOP-A-01 | Method Verification | SOP | Always | in the pack |
| LAB-SOP-A-02 | Method Validation | SOP | Always | in the pack |
| LAB-SOP-A-03 | Internal Quality Control (IQC) | SOP | Always | Download sample (EN, .docx) → |
| LAB-SOP-A-04 | External Quality Assessment (EQA/PT) | SOP | Always | in the pack |
| LAB-SOP-A-06 | Analytical Run and Batch Management | SOP | Always | in the pack |
| LAB-SOP-A-07 | Analytical Error Management | SOP | Always | in the pack |
| LAB-SOP-A-08 | Analyzer Startup and Shutdown | SOP | Always | in the pack |
| LAB-SOP-QC-01 | QC Rules (Westgard/Trend) and Actions | SOP | Always | Download sample (EN, .docx) → |
Examination — Safety, IT & Admin · 12
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-SOP-20 | Patient Identification and Record Correlation | SOP | Always | in the pack |
| LAB-SOP-32 | Backup and Restore Testing | SOP | Always | in the pack |
| LAB-SOP-AC-01 | Access Control to Testing Areas | SOP | Always | in the pack |
| LAB-SOP-CUST-04 | Contract and Service Agreement | SOP | Always | in the pack |
| LAB-SOP-ENV-01 | Temperature and Humidity Monitoring — Execution | SOP | Always | in the pack |
| LAB-SOP-EQ-05 | Troubleshooting | SOP | Always | in the pack |
| LAB-SOP-IT-01 | IT Downtime: Manual Mode, Recovery and Records | SOP | Always | in the pack |
| LAB-SOP-SF-01 | Personal Protective Equipment (PPE) Use | SOP | Always | in the pack |
| LAB-SOP-SF-02 | Spill Management | SOP | Always | in the pack |
| LAB-SOP-SF-03 | Biological Waste Management | SOP | Always | in the pack |
| LAB-SOP-SF-04 | Fire Safety Instructions | SOP | Always | in the pack |
| LAB-SOP-SF-05 | Sharps Management | SOP | Always | in the pack |
Examination — Discipline-Specific · 17
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-SOP-BIO-01 | Biochemistry Analyzer Operation (Startup/Shutdown) and Daily Maintenance | SOP | Clinical biochemistry | in the pack |
| LAB-SOP-BIO-02 | Biochemistry Testing — Routine Process | SOP | Clinical biochemistry | in the pack |
| LAB-SOP-BIO-03 | Biochemistry — Internal Quality Control (IQC) in Section | SOP | Clinical biochemistry | in the pack |
| LAB-SOP-BIO-04 | Biochemistry — External Quality Assessment (EQA/PT) in Section | SOP | Clinical biochemistry | in the pack |
| LAB-SOP-BIO-08 | Biochemistry — Method/Reagent Change, Verification and Re-Assessment | SOP | Clinical biochemistry | in the pack |
| LAB-SOP-COAG-01 | Coagulation Analyzer Operation (Startup/Shutdown) and Daily Maintenance | SOP | Coagulation | in the pack |
| LAB-SOP-COAG-02 | Coagulation — PT/INR, APTT and Core Test Performance | SOP | Coagulation | in the pack |
| LAB-SOP-COAG-03 | Coagulation — Internal Quality Control (IQC) in Section | SOP | Coagulation | in the pack |
| LAB-SOP-COAG-04 | Coagulation — External Quality Assessment (EQA/PT) in Section | SOP | Coagulation | in the pack |
| LAB-SOP-HEM-01 | Hematology Analyzer Operation (Startup/Shutdown) and Daily Maintenance | SOP | Hematology | in the pack |
| LAB-SOP-HEM-03 | Hematology — Internal Quality Control (IQC) in Section | SOP | Hematology | in the pack |
| LAB-SOP-HEM-04 | Peripheral Blood Smear — Preparation, Staining and Microscopy | SOP | Hematology | in the pack |
| LAB-SOP-HEM-06 | Hematology — External Quality Assessment (EQA/PT) in Section | SOP | Hematology | in the pack |
| LAB-SOP-IMM-01 | Immunology — Analyzer/Immunoassay Performance (Routine Process) | SOP | Immunology / immunoassay | in the pack |
| LAB-SOP-IMM-02 | Immunology — Internal Quality Control (IQC) in Section | SOP | Immunology / immunoassay | in the pack |
| LAB-SOP-IMM-03 | Immunology — External Quality Assessment (EQA/PT) in Section | SOP | Immunology / immunoassay | in the pack |
| LAB-SOP-UR-03 | Urinalysis — Internal Quality Control (IQC) | SOP | Urinalysis | in the pack |
Post-Examination — General · 16
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-P-15 | Incident and Accident Notification and Registration Policy | Policy | Always | in the pack |
| LAB-P-38 | Turnaround Time (TAT) Policy | Policy | Always | in the pack |
| LAB-P-39 | Clinical Result Release Policy | Policy | Always | in the pack |
| LAB-P-40 | Critical Result Management Policy | Policy | Always | in the pack |
| LAB-P-42 | Result Authorization and Amendment Policy | Policy | Always | in the pack |
| LAB-PR-16 | Incident Notification and Management Procedure | Procedure | Always | in the pack |
| LAB-PR-22 | Post-Examination Process Procedure | Procedure | Always | in the pack |
| LAB-PR-32 | Result Authorization, Amendment and Re-Release Procedure | Procedure | Always | in the pack |
| LAB-SOP-18 | Result Authorization | SOP | Always | in the pack |
| LAB-SOP-19 | Critical Results Management | SOP | Always | Download sample (EN, .docx) → |
| LAB-SOP-23 | EQA/PT Program Management and Results Analysis | SOP | Always | in the pack |
| LAB-SOP-CUST-03 | Referral Laboratory Management and Results Control | SOP | Always | in the pack |
| LAB-SOP-PO-01 | Result Validation (Result Review) | SOP | Always | in the pack |
| LAB-SOP-PO-02 | Result Reporting Procedure (Reporting/Release) | SOP | Always | in the pack |
| LAB-SOP-PO-03 | Critical Results Notification | SOP | Always | in the pack |
| LAB-SOP-PO-07 | Results Amendment and Re-Release | SOP | Always | in the pack |
Post-Examination — Discipline-Specific · 9
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-SOP-BIO-05 | Biochemistry — Result Review/Delta-Check and Reflex Actions | SOP | Clinical biochemistry | in the pack |
| LAB-SOP-COAG-06 | Coagulation — Critical Results Notification (INR/APTT and Others) | SOP | Coagulation | in the pack |
| LAB-SOP-HEM-02 | Complete Blood Count (CBC) — Performance and Result Authorization | SOP | Hematology | in the pack |
| LAB-SOP-HEM-05 | Hematology — Pathological Results Confirmation/Reflex Algorithm | SOP | Hematology | in the pack |
| LAB-SOP-HEM-07 | Hematology — Critical Results Management | SOP | Hematology | in the pack |
| LAB-SOP-IMM-05 | Immunology — Result Review and Reporting (Interpretive Comments) | SOP | Immunology / immunoassay | in the pack |
| LAB-SOP-UR-01 | Urinalysis — Test Strip and Result Recording | SOP | Urinalysis | in the pack |
| LAB-SOP-UR-02 | Urine Sediment — Microscopy and Reporting | SOP | Urinalysis | in the pack |
| LAB-SOP-UR-05 | Urinalysis — Result Review and Critical Pathological Findings Management | SOP | Urinalysis | in the pack |
Forms · 21
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-FR-CUST-05 | Client Satisfaction Short Survey | Form | Always | in the pack |
| LAB-FR-DOC-01 | Document Change Request Form | Form | Always | in the pack |
| LAB-FR-HR-05 | Onboarding Checklist | Form | Always | in the pack |
| LAB-FR-HR-07 | Vaccination/Health Record | Form | Always | in the pack |
| LAB-FR-IT-01 | IT Access Log | Form | Always | in the pack |
| LAB-FR-IT-03 | Audit Trail Review Log | Form | Always | in the pack |
| LAB-FR-IT-04 | Backup Performance Log | Form | Always | in the pack |
| LAB-FR-IT-05 | Restore Testing Log | Form | Always | in the pack |
| LAB-FR-IT-06 | Downtime Log | Form | Always | in the pack |
| LAB-FR-MRM-04 | Risk and CAPA Status Review (MRM Annex) | Form | Always | in the pack |
| LAB-FR-MRM-05 | Resource Request Form | Form | Always | in the pack |
| LAB-FR-MRM-06 | Management Decisions and Actions Tracker | Form | Always | in the pack |
| LAB-FR-MU-01 | Measurement Uncertainty (MU) Calculation Sheet | Form | Always | in the pack |
| LAB-FR-RISK-01 | Risk Assessment Form | Form | Always | in the pack |
| LAB-FR-RISK-04 | Impartiality/Conflict of Interest Declaration | Form | Always | in the pack |
| LAB-FR-RISK-05 | Risk Treatment Plan | Form | Always | in the pack |
| LAB-FR-RISK-06 | Risk Monitoring Record | Form | Always | in the pack |
| LAB-FR-SM-05 | Aliquoting Log | Form | Always | in the pack |
| LAB-FR-SM-06 | Sample Storage Location Log | Form | Always | in the pack |
| LAB-FR-SM-07 | Sample Storage Temperature Log | Form | Always | in the pack |
| LAB-FR-SM-08 | Chain of Custody Form | Form | Always | in the pack |
Registers · 4
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-R-01 | Document Register | Register | Always | in the pack |
| LAB-R-02 | SOP Register | Register | Always | in the pack |
| LAB-R-07 | Incident Register | Register | Always | in the pack |
| LAB-R-10 | Risk Register | Register | Always | in the pack |
Matrices · 3
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-MX-01 | Authorization Matrix | Matrix | Always | in the pack |
| LAB-MX-03 | Risk Matrix | Matrix | Always | in the pack |
| LAB-MX-04 | Retention Matrix | Matrix | Always | in the pack |
Job Descriptions · 10
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| LAB-JD-01 | Job Description — Laboratory Director | Job description | Always | in the pack |
| LAB-JD-02 | Job Description — Quality Manager | Job description | Always | in the pack |
| LAB-JD-03 | Job Description — Biochemistry Section Head | Job description | Always | in the pack |
| LAB-JD-04 | Job Description — Hematology Section Head | Job description | Always | in the pack |
| LAB-JD-05 | Job Description — Coagulation Section Head | Job description | Always | in the pack |
| LAB-JD-06 | Job Description — Immunology Section Head | Job description | Always | in the pack |
| LAB-JD-07 | Job Description — Urinalysis Section Head | Job description | Always | in the pack |
| LAB-JD-08 | Job Description — IT/Information Security Lead | Job description | Always | in the pack |
| LAB-JD-09 | Job Description — Equipment Custodian | Job description | Always | in the pack |
| LAB-JD-10 | Job Description — HR/Training Lead | Job description | Always | in the pack |
Download the complete pack — free
All 184 documents, English and Georgian. No payment, no account.
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