ISO 15189 Ready · The library
146 documents, English and Georgian — the structure and samples free, the pack on order
See every code and title, read the samples, then order the English pack or the Georgian edition — or run the free Simulation first.
35 policies · 20 procedures · 91 SOPs · 115 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 document carries a document-control block, purpose, scope, responsibilities, the procedure or SOP steps, the records it produces and its references — ISO 15189:2022, CLSI, WHO and the national regulation. The structure and six samples are free so that a laboratory can judge the quality before paying; the pack is delivered within one working day of the bank transfer.
Free
the structure (Excel index, this map) and the six sample documents marked below
The pack
English € 390 · Georgian edition (PHIG-adapted, English included) € 790 · generated and verified + € 300
Governance — Document Control & Risk Management · 7
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| P-01 | Quality Policy | Policy | Always | EN · KA |
| P-02 | Document Control Policy | Policy | Always | in the pack |
| P-03 | Records Management and Retention Policy | Policy | Always | in the pack |
| P-04 | Risk Management Policy | Policy | Always | in the pack |
| PR-01 | Document Control Procedure | Procedure | Always | in the pack |
| PR-02 | Records Control and Retention Procedure | Procedure | Always | in the pack |
| PR-03 | Risk Assessment Procedure | Procedure | Always | in the pack |
Management Requirements — Audit, CAPA, Review, Complaints, Impartiality · 16
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| P-05 | Internal Audit Policy | Policy | Always | in the pack |
| P-06 | Nonconformity, Correction and CAPA Policy | Policy | Always | in the pack |
| P-07 | Management Review Policy | Policy | Always | in the pack |
| P-10 | Data Protection and Confidentiality Policy | Policy | Always | in the pack |
| P-23 | Complaints Management Policy | Policy | Always | in the pack |
| P-24 | Ethics and Impartiality Policy | Policy | Always | in the pack |
| P-25 | Communication Policy | Policy | Always | in the pack |
| PR-04 | Internal Audit Conduct Procedure | Procedure | Always | EN · KA |
| PR-05 | CAPA Process Management Procedure | Procedure | Always | in the pack |
| PR-06 | Management Review Procedure | Procedure | Always | in the pack |
| SOP-21 | Nonconforming Work, Hold and Release, and CAPA | SOP | Always | in the pack |
| SOP-CUST-01 | Complaint Intake, Investigation and Response | SOP | Always | in the pack |
| SOP-CUST-02 | Client Feedback and Satisfaction Assessment | SOP | Always | in the pack |
| SOP-HR-04 | Personnel Awareness: Impartiality and Confidentiality | SOP | Always | in the pack |
| SOP-PO-05 | Data Correction | SOP | Always | in the pack |
| SOP-PO-06 | Customer Communication | SOP | Always | in the pack |
Resources — Personnel · 8
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| P-08 | Personnel Competence Policy | Policy | Always | in the pack |
| P-09 | Training and Education Policy | Policy | Always | in the pack |
| P-31 | Personnel Health and Immunization Policy | Policy | Always | in the pack |
| PR-07 | Competency Assessment Procedure | Procedure | Always | in the pack |
| PR-08 | Training Planning and Delivery Procedure | Procedure | Always | in the pack |
| SOP-HR-01 | Competency Assessment | SOP | Always | in the pack |
| SOP-HR-02 | Training Delivery and Attendance Documentation | SOP | Always | in the pack |
| SOP-HR-03 | Personnel Health, Immunization and Exposure Management | SOP | Always | in the pack |
Resources — Equipment & Reagents · 18
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| P-18 | Equipment Management Policy | Policy | Always | in the pack |
| P-19 | Calibration, Verification and Traceability Policy | Policy | Always | in the pack |
| P-20 | Equipment Maintenance Policy | Policy | Always | in the pack |
| P-34 | Equipment Decommissioning Policy | Policy | Always | in the pack |
| PR-09 | Equipment Selection, Acquisition and Acceptance Procedure | Procedure | Always | in the pack |
| PR-10 | Equipment Calibration and Traceability Procedure | Procedure | Always | in the pack |
| PR-11 | Equipment Performance Verification Procedure | Procedure | Always | in the pack |
| SOP-A-05 | Calibration and Calibration Verification | SOP | Always | in the pack |
| SOP-A-09 | Reagent Receipt, Storage and Lot Verification | SOP | Always | in the pack |
| SOP-BIO-06 | Biochemistry — Reagent/Calibrator Receipt, Storage and Lot Verification | SOP | Clinical biochemistry | in the pack |
| SOP-BIO-07 | Biochemistry Equipment Maintenance and Malfunction Management | SOP | Clinical biochemistry | in the pack |
| SOP-EQ-01 | Equipment Receipt, Inventory and Acceptance | SOP | Always | in the pack |
| SOP-EQ-02 | Calibration Log Maintenance and Control | SOP | Always | in the pack |
| SOP-EQ-03 | Scheduled Maintenance | SOP | Always | in the pack |
| SOP-EQ-04 | Equipment Breakdown Management | SOP | Always | in the pack |
| SOP-EQ-06 | Equipment Decommissioning | SOP | Always | in the pack |
| SOP-IMM-04 | Immunology Reagent and Calibrator Lot Verification and Calibration | SOP | Immunology / immunoassay | in the pack |
| 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 |
|---|---|---|---|---|
| P-11 | IT and Information Security Policy | Policy | Always | in the pack |
| P-12 | Biosafety Policy | Policy | Always | in the pack |
| P-14 | Medical Waste Management Policy | Policy | Always | in the pack |
| P-21 | Environmental Conditions Monitoring Policy | Policy | Always | in the pack |
| P-22 | Supplier and External Services Management Policy | Policy | Always | in the pack |
| P-28 | Fire Safety Policy | Policy | Always | in the pack |
| PR-12 | Environmental Conditions Monitoring Procedure | Procedure | Always | in the pack |
| PR-13 | Cleaning and Disinfection Procedure | Procedure | Always | in the pack |
| PR-29 | Supplier Evaluation and Monitoring Procedure | Procedure | Always | in the pack |
| SOP-31 | Information Security: Passwords, Access and Logging | SOP | Always | in the pack |
| SOP-SF-07 | Facility Cleaning Schedule and Control | SOP | Always | in the pack |
Pre-Examination — Specimen Pathway · 18
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| P-16 | Specimen Management Policy | Policy | Always | in the pack |
| P-17 | Specimen Rejection Policy | Policy | Always | in the pack |
| PR-17 | Specimen Reception Procedure | Procedure | Always | in the pack |
| PR-18 | Specimen Rejection Procedure | Procedure | Always | in the pack |
| SOP-COAG-05 | Coagulation Specimen Acceptance and Rejection Criteria (Citrate Tubes) | SOP | Coagulation | in the pack |
| SOP-PA-01 | Patient Preparation | SOP | Always | in the pack |
| SOP-PA-02 | Specimen Collection | SOP | Always | in the pack |
| SOP-PA-03 | Specimen Labeling and Identification | SOP | Always | EN · KA |
| SOP-PA-04 | Specimen Packaging | SOP | Always | in the pack |
| SOP-PA-05 | Specimen Transportation | SOP | Always | in the pack |
| SOP-PA-06 | Specimen Reception at Laboratory | SOP | Always | in the pack |
| SOP-PA-07 | Specimen Rejection | SOP | Always | in the pack |
| SOP-PA-08 | Pre-Analytical Storage | SOP | Always | in the pack |
| SOP-PA-09 | Pre-Treatment: Centrifugation, Serum Separation and Division | SOP | Always | in the pack |
| SOP-PA-10 | Aliquoting and Secondary Container Identification | SOP | Always | in the pack |
| SOP-PA-11 | Specimen Destruction and Retention Completion | SOP | Always | in the pack |
| SOP-PA-12 | Chain of Custody (When Required) | SOP | Always | in the pack |
| SOP-UR-04 | Urine Specimen Acceptance and Rejection Criteria | SOP | Urinalysis | in the pack |
Examination — General Analytical · 14
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| P-30 | Laboratory Access Control Policy | Policy | Always | in the pack |
| P-36 | Analytical Method Validation Policy | Policy | Always | in the pack |
| P-37 | Quality Control (QC/IQC/EQA) Policy | Policy | Always | in the pack |
| P-43 | IT Downtime and Access Control Policy | Policy | Always | in the pack |
| PR-23 | QC/IQC/EQA System Management Procedure | Procedure | Always | in the pack |
| SOP-A-01 | Method Verification | SOP | Always | in the pack |
| SOP-A-02 | Method Validation | SOP | Always | in the pack |
| SOP-A-03 | Internal Quality Control (IQC) | SOP | Always | EN · KA |
| SOP-A-04 | External Quality Assessment (EQA/PT) | SOP | Always | in the pack |
| SOP-A-06 | Analytical Run and Batch Management | SOP | Always | in the pack |
| SOP-A-07 | Analytical Error Management | SOP | Always | in the pack |
| SOP-A-08 | Analyzer Startup and Shutdown | SOP | Always | in the pack |
| SOP-QC-01 | QC Rules (Westgard/Trend) and Actions | SOP | Always | EN · KA |
| SOP40-MU | Measurement Uncertainty (MU): Calculation and Application Rules | SOP | Always | in the pack |
Examination — Safety, IT & Admin · 12
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| SOP-20 | Patient Identification and Record Correlation | SOP | Always | in the pack |
| SOP-32 | Backup and Restore Testing | SOP | Always | in the pack |
| SOP-AC-01 | Access Control to Testing Areas | SOP | Always | in the pack |
| SOP-CUST-04 | Contract and Service Agreement | SOP | Always | in the pack |
| SOP-ENV-01 | Temperature and Humidity Monitoring — Execution | SOP | Always | in the pack |
| SOP-EQ-05 | Troubleshooting | SOP | Always | in the pack |
| SOP-IT-01 | IT Downtime: Manual Mode, Recovery and Records | SOP | Always | in the pack |
| SOP-SF-01 | Personal Protective Equipment (PPE) Use | SOP | Always | in the pack |
| SOP-SF-02 | Spill Management | SOP | Always | in the pack |
| SOP-SF-03 | Biological Waste Management | SOP | Always | in the pack |
| SOP-SF-04 | Fire Safety Instructions | SOP | Always | in the pack |
| SOP-SF-05 | Sharps Management | SOP | Always | in the pack |
Examination — Discipline-Specific · 17
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| SOP-BIO-01 | Biochemistry Analyzer Operation (Startup/Shutdown) and Daily Maintenance | SOP | Clinical biochemistry | in the pack |
| SOP-BIO-02 | Biochemistry Testing — Routine Process | SOP | Clinical biochemistry | in the pack |
| SOP-BIO-03 | Biochemistry — Internal Quality Control (IQC) in Section | SOP | Clinical biochemistry | in the pack |
| SOP-BIO-04 | Biochemistry — External Quality Assessment (EQA/PT) in Section | SOP | Clinical biochemistry | in the pack |
| SOP-BIO-08 | Biochemistry — Method/Reagent Change, Verification and Re-Assessment | SOP | Clinical biochemistry | in the pack |
| SOP-COAG-01 | Coagulation Analyzer Operation (Startup/Shutdown) and Daily Maintenance | SOP | Coagulation | in the pack |
| SOP-COAG-02 | Coagulation — PT/INR, APTT and Core Test Performance | SOP | Coagulation | in the pack |
| SOP-COAG-03 | Coagulation — Internal Quality Control (IQC) in Section | SOP | Coagulation | in the pack |
| SOP-COAG-04 | Coagulation — External Quality Assessment (EQA/PT) in Section | SOP | Coagulation | in the pack |
| SOP-HEM-01 | Hematology Analyzer Operation (Startup/Shutdown) and Daily Maintenance | SOP | Hematology | in the pack |
| SOP-HEM-03 | Hematology — Internal Quality Control (IQC) in Section | SOP | Hematology | in the pack |
| SOP-HEM-04 | Peripheral Blood Smear — Preparation, Staining and Microscopy | SOP | Hematology | in the pack |
| SOP-HEM-06 | Hematology — External Quality Assessment (EQA/PT) in Section | SOP | Hematology | in the pack |
| SOP-IMM-01 | Immunology — Analyzer/Immunoassay Performance (Routine Process) | SOP | Immunology / immunoassay | in the pack |
| SOP-IMM-02 | Immunology — Internal Quality Control (IQC) in Section | SOP | Immunology / immunoassay | in the pack |
| SOP-IMM-03 | Immunology — External Quality Assessment (EQA/PT) in Section | SOP | Immunology / immunoassay | in the pack |
| SOP-UR-03 | Urinalysis — Internal Quality Control (IQC) | SOP | Urinalysis | in the pack |
Post-Examination — General · 16
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| P-15 | Incident and Accident Notification and Registration Policy | Policy | Always | in the pack |
| P-38 | Turnaround Time (TAT) Policy | Policy | Always | in the pack |
| P-39 | Clinical Result Release Policy | Policy | Always | in the pack |
| P-40 | Critical Result Management Policy | Policy | Always | in the pack |
| P-42 | Result Authorization and Amendment Policy | Policy | Always | in the pack |
| PR-16 | Incident Notification and Management Procedure | Procedure | Always | in the pack |
| PR-22 | Post-Examination Process Procedure | Procedure | Always | in the pack |
| PR-32 | Result Authorization, Amendment and Re-Release Procedure | Procedure | Always | in the pack |
| SOP-18 | Result Authorization | SOP | Always | in the pack |
| SOP-19 | Critical Results Management | SOP | Always | EN · KA |
| SOP-23 | EQA/PT Program Management and Results Analysis | SOP | Always | in the pack |
| SOP-CUST-03 | Referral Laboratory Management and Results Control | SOP | Always | in the pack |
| SOP-PO-01 | Result Validation (Result Review) | SOP | Always | in the pack |
| SOP-PO-02 | Result Reporting Procedure (Reporting/Release) | SOP | Always | in the pack |
| SOP-PO-03 | Critical Results Notification | SOP | Always | in the pack |
| SOP-PO-07 | Results Amendment and Re-Release | SOP | Always | in the pack |
Post-Examination — Discipline-Specific · 9
| Code | Title | Type | Included when | Sample |
|---|---|---|---|---|
| SOP-BIO-05 | Biochemistry — Result Review/Delta-Check and Reflex Actions | SOP | Clinical biochemistry | in the pack |
| SOP-COAG-06 | Coagulation — Critical Results Notification (INR/APTT and Others) | SOP | Coagulation | in the pack |
| SOP-HEM-02 | Complete Blood Count (CBC) — Performance and Result Authorization | SOP | Hematology | in the pack |
| SOP-HEM-05 | Hematology — Pathological Results Confirmation/Reflex Algorithm | SOP | Hematology | in the pack |
| SOP-HEM-07 | Hematology — Critical Results Management | SOP | Hematology | in the pack |
| SOP-IMM-05 | Immunology — Result Review and Reporting (Interpretive Comments) | SOP | Immunology / immunoassay | in the pack |
| SOP-UR-01 | Urinalysis — Test Strip and Result Recording | SOP | Urinalysis | in the pack |
| SOP-UR-02 | Urine Sediment — Microscopy and Reporting | SOP | Urinalysis | in the pack |
| SOP-UR-05 | Urinalysis — Result Review and Critical Pathological Findings Management | SOP | Urinalysis | in the pack |
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English or Georgian edition; add the generated pack for your names and logo in every document.
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