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ISO 15189 Ready · The library
184 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 · 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 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
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
Order the pack
English or Georgian edition; add the generated pack for your names and logo in every document.
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