NABL Manuals
Master List of Displays
R001 Worklist
R002 Outsourced Register
R003 Current Kit Insert
R004 Calibration Insert
R005 Current QC Inserts
R006 Critical Value Reporting Register
R007 Calibration & Verification
R008 IQC LJ Chart
R009 Sample Dispatch
R010 EQAS Reports
R011 Sample Rejection
R012 Repeat Tests
R013 Reagent Inventory Register
R014 IQC preparation and Utilization Form
R015 Meeting Minutes Form
R016 Equipment Maintenance Register
R017 Laundry Register
R018 Room Temperature and Humidity Log
R019 Equipment Temperature Log
R019A Pressure log
R019B Voltage log
R020 Housekeeping Register
R021 Telephone Call Log Register
R022 Laboratory Training Register
R023 Histopathology Register
R024 Bone Marrow Register
R025 Cytology Register
R026 FNAC Register
R027 Cyto/Histo Correlation Register
R028 Staff Personal FILE
R029 Central Research Laboratory (CRL)
R030 EQAS PAYMENT DETAILS
R031 Patient Register OP,IP
R032 Equipment Factor Adjustment Register
R033 Sample Storage And Disposal Register
R034 Infectious Disease Communication Register
R035 Report Format Register
R036 List Of Services With Biological Reference Range
R037 Laboratory External Training Register
R038 Lot Verification Record
R039 Assets Requests Forms
R040 Bill Copy Register
R041 Material Receiving Register
R042 Visitors Register
R043 Staff Signature With Handwriting Record
R044 Internal Quality Control (IQC) Reports
R045 Handing Over Register
R046(A) Biomedical Waste Segregation Verification
R046(B) Biomedical Waste Segregation Verification
R047 Authority Approvals
R048 Outsourced Bill Register
R049 Test Request Forms (TRF)
R050 Departmental Internal Training Details Register
R051 Mycobacteriology AFB Register
R052 Bacteriology Register
R053 Communicable Disease Notification Form
R054 Incident Accident Record Register
R055 IQC RCA CA Register
R056 Lab Store Issue Forms
R057 EQAS Events And CAPA Recording Sheet
R058 Referral Laboratory Evaluation Form
R059 Slide And Block Dispatch Register
R060 Key Movement Register
R061 MASTER LIST OF DOCUMENTS
R062 NC, CA & PA Laboratory Form
R063 Master List Of Formats
R064 Critical Reagents Monitoring Register
R065 Test Lost Register
R066 Communication Register
R067 Mycology Register
R068 Blood Culture Register
R069 Equipment Performance Register
R070 Equipment Register
R071 Consumed Inventory Register
R072 Altered report Register
R073 Equipment Break Down/Service Register
R074 Laboratory Training Programme
R075 Material Indent And Receipt Register
R076 Material Consumption Register
R077 Department Test Register (Statistics)
R078 Phlebotomy Consumable Usage Register
R079 Turn Around Time Record Register
R080 Daily HIS Stock Register
R081 Special Stain Register
R082 Frozen Section Register
R083 Immunohistochemistry Register
R084 Microbiology Decontamination By Autoclaving
R085 Bit Register
R086 Report Despatch Register
R087 Learning Resources
R088 Students Observer Attendance Sheet
R089 IQC Split Testing And Prev Day Testing
R090 Department Checklist
R091 Miscellaneous Item Register
R092 Equipment Printouts
R093 Test Report Register
R094 Hypochlorite Preparation Schedule
R095 EQAS Test Sheet
(A) EQAS Chemistry Biorad Test Sheet
(B) EQAS Biorad - Immunoassay BC75 Test Sheet
(C) EQAS Biorad - Urine Chemistry BC45 Test Sheet
(D) ACBI CMC EQAS Chemistry And HbA1c
(E) Riqas Randox - Immunoassay RQ130 Test Sheet
(F) EQAS CMC ISHBT haemostasis
R096 Equipment History Sheet
R097 Laboratory Staff Induction Training Record
R098 Item Return Register
R099 Equipment Usage Register
R100 Parasitology Register
R101 Serology Register
R102 Prepared Reagent Register
R103 Attendance Register
R104 Duty List
R105 Laboratory Risk Analysis Form
R106 KPI QI File
R107 Delivery Challan
R108 Monthly Purchase Request
R109 Quotations
R110 Phlebotomy Summary Of Daily Collection
R111 Ward Collection Details
R112 Occurrence/variance Report (OVR)
R113 Master Test Request Formats
R114 Master List Of External Documents
R115 Master Lists
R116 MSDS File
R117 Test Surveillance Report
R118 Movement Register
R119 Laboratory Circular
R120 General Maintenance Register
R121 Asset Transfer Form
R122 Intra Departmental Discussions
R123 EQAS Comparison Chart
R124 UPS Checklist
R125 Autopsy Register
R126 Software Verification Report
R127 Hypochlorite Preparation Schedule For Blood Bank
R128 Solemn Declaration
R129 Test Amendment - Cancellation Request
R130 Laboratory Tariff
R131 Camp Register
R132 Internal Audit File
R133 Accession Register
R134 Obsolete Documents File
R135 Service agreements
R136 Outsourced Staff Register
R137 Outside Sample Receiving Register
R138 Employee Competency Evaluation Form
R139 Supplier Evaluation Form
R140 Clinicians Discussion And feedback
R141 Automatic Tissue Processing Workload & Time Log
R142 Internal Audit Plan
R143 Staff Feedback
R144 MRM Meeting Minutes
R145 Patient Laboratory Feedback Form
R146 Equipment Cal and PM Schedule Plan
R147 Document Change Request
R148 Complaint Register
R149 Corrective Action (CA) Register
R150 Preventive Action (PA) Register
R151 Biorad EQAS Troubleshooting Checklist
R152 Allied Health Sciences (BAAHS)
R153 New Equipment Installation Checklist
R154 Annual Refreshers Training Register
R155 SOP Procedure Communication Register
R156 EQAS/IQC Communication Form
R157 Pre-Appraisal - Review Format
R158 Employee Self Reporting Format
R159 Job Description
R160 BMW Linear Bags Distribution details
R161 CAPA CQI FORM
R162 Quality indicators
R163 Glucometer Records
R164 Pneumatic Chute Sample transport integrity check
R165 Retraining Register
R166 Biological Sterility report Register
R167 Inter Laboratory Comparison Record
R168 Deep Freezer Register (new 22.09)
R169 Profession Development Programmed Record
R170 Laboratory work Statistics
R171 Consent Forms (not required as it is part of TRF formats)
R172 New Material Verification Record
R173 Master List of Assets
R174 External Audit File - NABH
R175 External Audit File - NABL
R176 Document Control Register (new 22.09)
R177 Standard Strain Maintenance
R178 Positive Serum Sample Preservation Register
R179 Master List of Chemicals
R180 Selection criteria for equipment
R181 Selection criteria for reagents and consumable
R182 Formalin Fume Monitoring
R183 Bleeding Time & Clotting Time Register
R184 Inter Departmental Discussions
R185 EQAS Monthly Z Score
R186 Reprick and Complication
R187 Oxygen Cylinder Checklist
R188 Daily NC Register
R189 Procedure Validation
R190 Control Block Preparation & Usage Register
R191-A FORM-191 A-Checklist for Night shift and Sunday Duty
R191-B FORM-191 B-Checklist for Night shift and Sunday Duty-Phlebotomy
R191-C FORM-191 C - Competency Checklist for Blood Culture Collection
R191-D FORM-191 D - Competency Checklist Equipment Handling
R191-E FORM-191 E - Competency Checklist for IP Sample Collection
R191-F FORM-191 F - Competency Checklist for OP Sample Collection
R191-G FORM-191 G - Competency for Setting Up Projector
R191-H FORM-191 H - Competency for Inventory Module
R192 Dashboard Clearance Verification
R193 Faculty Competency Micro
R194 Laboratory Risk Register
R195 Patient Sample/Result/Information Release Consent Form
R196 Laboratory safety Audit Checklist
R197 POCT Forms
EDB 01 ISO 15189 2012 International Standard.
EDB 01-a ISO 15189 2022 International Standard.
EDB 04 NABL 112-Specific Criteria for Accreditation of Medical Laboratories
EDB 24 ISO-15190:2003 Medical Laboratories – Requirements for safety
EDB 25 Legal registration - Municipality
EDB 26 Biomedical waste agreement: Pollution Control Board
EDB 27 Biomedical waste agreement: IMAGE receipts
EDB 28 Pest Control Receipt/MOU
EDB 35-01to20 Agreements
BCMCH-MAN-0030-001 Laboratory –Biochemistry
BCMCH-MAN-0030-002 Laboratory –Primary Sample Collection Manual
BCMCH-MAN-0030-003 Laboratory –Hematology Manual
BCMCH-MAN-0030-004 Laboratory –Cyto & Histo Pathology Manual
BCMCH-MAN-0030-005 Laboratory –Microbiology Manual
BCMCH-MAN-0030-006 Laboratory –Sample Separation
BCMCH-MAN-0030-007 Laboratory –Blood CentreManual
BCMCH-MAN-0030-008 Laboratory –CRL MolecularManual
BCMCH-MAN-0030-009 Laboratory –HIS & LIS
BCMCH-MAN-0030-010 Laboratory –Clinical PathologyManual
BCMCH-MAN-0030-011 Laboratory –Quality Manual
BCMCH-MAN-0030-012 Laboratory –Quality System Procedure
BCMCH-MAN-0030-015 POCT Manual
BCMCH-MAN-0007 Nursing Manual - General
BCMCH-MAN-0002 ER
BCMCH-MAN-0011 HOUSE KEEPING
BCMCH-MAN-0019 SECURITY
BCMCH-MAN-0021 PUBLIC RELATIONS
BCMCH-MAN-0045 OPERATIONS
BCMCH-MAN-0040 HR
BCMCH-MAN-0079 FIRE SAFETY
BCMCH-MAN-0063 DISASTER MANAGEMENT
BCMCH-MAN-0070 EMERGENCY CODES
BCMCH-MAN-0047 PURCHASE
BCMCH-MAN-0075 Risk Analysis
BCMCH-MAN-0050 SAFETY MANUAL
BCMCH-MAN-0010 HIC
BCMCH-MAN-0041 MEDICAL INFORMATICS
BCMCH-MAN-0048 MATERIALS STORE
BCMCH-MAN-0049 MANUAL ON COMMITTEES
OVR Form (BCMCH/MRD/Quality-001)
OPD Feedback form (BCMCH/MRD/Quality-002 v1.1)
IPD Feedback Form (BCMCH/MRD/Quality-003 v1.1)
BCMCH Performance appraisal format (BCMCH/MRD/HRD-013)
DISP-001 Quality Policy and Objectives
DISP-002 List of Equipment and Authorised Personnel
DISP-003 With Gloves & Without Gloves
DISP-004 Preventive Maintenance Plan
DISP-005 List of TAT & Critical TAT
DISP-006 How to Hand Wash
DISP-007 IQC Processing & Rejection Criteria
DISP-008 Equipment Calibration Plan
DISP-009 Critical Alert Values Level
DISP-010 Calibration Schedule or Plan For Analytes detailed
DISP-011 Order Of Blood Collection
DISP-012 Organisation Chart
DISP-013 Repeat Test Criteria
DISP-014 Spill Management - Biological
DISP-015 Sample Rejection Criteria
DISP-016 Do's Dont's in Laboratory
DISP-017 Work Desk Instruction Biorad D10
DISP-018 Work Desk Instruction - AU 480
DISP-019 Work Desk Instructions- Centrifuge
DISP-020 Work Desk Instruction 9180 Electrolyte Analyzer
DISP-021 Work Desk Instruction-Vidas
DISP-022 Work Desk Instruction - Maglumi 2000
DISP-023 Work Desk Instruction-DXH 600/800
DISP-024 Work Desk Instruction - Mindray
DISP-025 Work Desk Instruction - Bact Alert
DISP-026 Work Desk Instruction - Vitek
DISP-027 Work Desk Instruction -Electrophoresis
DISP-028 Work Desk Instruction -Stago
DISP-029 Biochemistry Process Flow
DISP-030 Hematology Process Flow
DISP-031 Microbiology Process Flow
DISP-032 Histopathology Process Flow
DISP-033 Blood Bank Process flow
DISP-034 IP Collection Process Flow
DISP-035 OP Collection Process Flow
DISP-036 Sample Separation Process flow
DISP-037 Masterlist Of Documents
DISP-038 Master list of External Documents
DISP-039 Master List Of Records And Formats
DISP-040 Master List of Staff
DISP-041 Master List of IQC, EQAS ,ILC
DISP-042 Master List Of Scope Of Services With TAT
DISP-043 HIS Authorization Matrix
DISP-044 EQAS Schedule
DISP-045 Internal Quality Control IQC Process Flow
DISP-046 Work Desk Instruction - Cytocentrifuge
DISP-047 IQC RCA CA PA Flow Diagram
DISP-048 Purchase And Inventory Process Flow
DISP-049 Work Desk Instruction -AU 680
DISP-050 A Potential Blood Donor Process flow
DISP-051 Grouping And Cross Matching Process Flow
DISP-052 Work Desk Instruction - Autoclave
DISP-053 Chemo Spill Management
DISP-054 Floor Pan
DISP-055 Master List Of Equipments
DISP-056 List Of Authorized Signatories
DISP-057 EQAS Root Cause Analysis Guide
DISP-058 Emergency Codes And Activation
DISP-059 MSDS Display
DISP-060 Phlebotomy Step By Step Procedure
DISP-061 Responsibility And Authorization Matrix
DISP-062 Licence Municipality
DISP-063 Licence Of Clinical Establishment
DISP-064 Authorization Matrix duplicate of 061
DISP-065 Internal Data Backup Schedule
DISP-066 Annual training Calendar
DISP-067 Annual Goal For Lab Personnel
DISP-068 Master List Of Displays
DISP-069 Master List Of Cupboard
DISP-070 Department Wise Monthly TAT
DISP-071 Annual Internal Audit
DISP-072 Master List Of Training Topics And Resource Personnel
DISP-073 Master List of Obsolete Documents and Retention
DISP-074 Master List Of Reference Materials And Traceability
DISP-075 Master list of Approved Laboratory Positions
DISP-076 Master list of Online Forms
DISP-077 Master List Of Scope With Biological Reference Range
DISP-078 Master List Approved Suppliers
DISP-079 FNAC Guidelines
DISP-080 Patient Identification Guidelines
DISP-081 Organogram Departments
DISP-082 Primary sample collection facility locations
DISP-083 Work Desk Instruction Combilyzer
DISP-084 Calibration Policy
DISP-085 EQAS Renewal Details
DISP-086 BCMCH Induction and refresher topics
DISP-087 Professional Development Plan
DISP-088 Master List Of Inter Phased Machines and Tests
DISP-089 Master List Of Outsourced Tests
DISP-090 Master Chart Of Quality Indicators
DISP-091 Equipment Responsibility and Authorization Matrix
DISP-092 Department wise 6M Average TAT
DISP-093 Master list of chemicals and hazardous materials used in Lab
DISP-094 List of Medicines in the Crash Cart
DISP-095 Procedure for Facility maintenance & Equipment Breakdown
DISP-096 First Aid Kit Locations & Details
DISP-097 Key Personnels and Deputies
DISP-098 Code Yellow Lab Process Flow
DISP-099 Document Interface Table
DISP-100 Spill Kit Location & Details
DISP-101 Work Desk Instructions - DT100
DISP-102 Work Desk Instructions - Vitros 3600
DISP-103 Work Desk Instructions - Tissue Processor
DISP-104 - Work Desk Instructions - Glucometer
DISP-105 Work Desk Instructions - ABG 800/800 Flex
DISP-106 Work Desk Instructions -Biosafety Cabinet
DISP-107 Work Desk Instructions -Electronic Balance
DISP-108 Work Desk Instructions -Elisa Reader
DISP-109 Work Desk Instructions -Nephelometer
DISP-110 Work Desk Instructions -pH Meter
DISP-111 Work Desk Instructions -Formalin Preparation
DISP-112 Work Desk Instructions -Biorad D10 AL
DISP-113 Work Desk Instructions -Biorad Variant II Turbo
DISP-114 Work Desk Instructions -Kryptor compact
DISP-115 Work Desk Instructions -Vesmatic
DISP-116 Work Desk Instructions -FUS
DISP-117 Work Desk Instructions -ABL 800 Basic
DISP-118 Work Desk Instructions -Leica ASP 300 S
DISP-119 Work Desk Instructions -Embedding Leica EG1150H
DISP-120 Work Desk Instructions -Paraffin Dispensor
DISP-121 Work Desk Instructions -COLD AREA
DISP-122 Work Desk Instructions -Microtome
DISP-123 Work Desk Instructions -Semi automated Microtome
DISP-124 Work Desk Instructions -WATER BATH
DISP-125 Work Desk Instructions -SLIDE WARMING TABLE
DISP-126 Work Desk Instructions - SLIDE FLATTENING TABLE
DISP-127 Work Desk Instructions - MULTISTAINER – Leica ST5020
DISP-128 Work Desk Instructions -CRYOSTAT – LEICA CM1860UV
DISP-129 Master List of Glucometers
DISP-130 Work Desk Instructions -INCUBATOR
DISP-131 Work Desk Instructions -Rapid test cards
DISP-132 Work Desk Instructions -LEPTOSPIRA IgM ELISA (J. Mitra)
DISP-133 Work Desk Instructions -DENGUE IgM ELISA (J. Mitra)
DISP-134 Work Desk Instruction SCRUB TYPHUS IgM ELISA (Inbios)
DISP-135 Work Desk Instruction Cyto centrifuge
DISP-136 SPILL KIT ITEMS CHECK LIST
DISP-137 Work Desk Instruction Standard F200
DISP-138 Work Desk Instruction AQ T 90 FLEX
DISP-139 Work Desk Instructions -Truelab RT PCR
DISP-140 Covid 19 Testing Process Flow
DISP-141 CRL Process flow
DISP-142 Sample Collection Procedure -Covid 19
DISP-143 Work Desk Instructions -GeneXpert IV R2
DISP-144 Donning
DISP-145 Doffing
DISP-146 Work Desk Instructions -Gel Centifuge
DISP-147 Clinical Pathology Process flow
DISP-148 Work Desk Instructions -CFX-96-Dx Open RT PCR
DISP-149 Work Desk Instructions -Ependrof Centrifuge
DISP-150 Work Desk Instructions -Short Spin Centrifuge
DISP-151 Work Desk Instructions -Master Mix
DISP-152 Work Desk Instructions -Extraction
DISP-153 Work Desk Instructions -Template
DISP-154 Measurable parameter of Quality Objectives
DISP-155 BCMCH Lab Sample retention duration
DISP-156 Work Desk Instructions -Standard F200
DISP-157 Time limit for additional testing
DISP-158 Critical Alert Reporting Protocol
DISP-159 Master list of purchase items with conditions for acceptance
DISP-160 Work Desk Instruction VDRL Rotator
DISP-161 Instruction for sending Biopsy samples
DISP-162 Sample Collection Timings
DISP-163 WDI Atellica Neph 630 Protein Analyser
DISP-164 WDI for Fluroscent Microscope
DISP-165 WDI Operation Procedure of Autolumo A2000 Plus
DISP-166 Work Desk Instructions of Mispa i3
DISP-167 WDI Operation & Maintenance of DXH 900 Coulter
DISP-168 WDI Operation & Maintenance of STA Compact Max 3
DISP-169 WDI Operation & Maintenance of STA Satellite Max
QSP-1: Personnel (6.2)
QSP-2: Accommodation And Environmental Condition (5.2.6)
QSP-3: Store - External Services And Supplies (6.6)
QSP-4: Lab Equipment & Maintenance (6.4)
QSP-5: Control Of Records (8.4,6.2.5)
QSP-6: Document Control (8.2)
QSP-7: Pre Examination Processes (7.2,6.3.5)
QSP-8: Assuring Quality Of Examination Procedure (7.3)
QSP-9: Post Examination Processes (7.4)
QSP-10: Examination Of Referral Laboratories (6.8.2)
QSP-11: External Services And Supplies (6.8)
QSP-12: Evaluation And Audits (8.8)
QSP-13: Management Review (8.9)
QSP-14: Corrective Action (8.7.2)
QSP-15: Preventive Action (8.5)
QSP-16: Resolution Of Complaints (7.7)
QSP-17: Identification And Control Of Nonconformities (7.5)
QSP-18: Reporting Of Results (7.4.1)
QSP-19: Patient Registration And Front Office (7.2.2)
QSP-20: Examination Processes (7.3)
QSP-21: Safety & Risk (8.5.1)
QSP-22: Review Of Contracts (6.7)
QSP-23: Laboratory Information Management (7.6)
QSP-24: Guideline For User Responsibility ()
QSP-25: System Maintenance ()
QSP-26: Ethics And Patient Confidentiality (4.1,5.6)
QSP-27: Staff Competence (4.1.15, 5.1.6)
QSP-28 Continual Improvement
QSP-29 Inhouse Calibration
QSP-30 Advisory services
QSP-31 Release of Results
QSP-32 Digitization of documents and Records (8.4.3)
QSP-33 Point of Care Testing (POCT) (Annex A)
QSP-34 Procedure for Use of Near Expiry and Expired Reagents
QSP-35 Contingency Plan
QSP-36 Research and Development
QSP-37 Procedure for the use of NABL Symbol at BCMCH Laboratory
D: Process Flow Chart
H: List Of Records
I: Sample Collection & Instructions
J: Sample Acceptance And Rejection
K: General Departmental Procedure
L: Quality Control Procedure
M: Equipment Operation & Maintenance Procedure
N: Equipment Back Up Plan
O: Measurement Of Uncertainty
P: TAT And STAT Recording & Monitoring
Q: Critical Alert Level Values/ Panic Values
R: Proficiency Testing Plan
S: Calibration Schedule For Test Parameters
T: Data Backup Plan
U: Generation Of Test Result
V: Repeat Test
W: Housekeeping Procedure
X: Personnel Protection & Safety
Y: Quality Indicators
Z: Treatment And Disposal Of Biomedical Waste
AA: Department Risk Analysis
OF-001 Equipment Comparison form
OF-002 Laboratory Risk Analysis form
OF-003 Laboratory Clinicians Feedback form
OF-004 Laboratory Staff Feedback form
OF-005 Laboratory Communication Register
OF-006 Laboratory Advisory Services
OF-007 Request form and sample audit
OF-008 Lab Maintenance and Issues Logger
OF-009 Laboratory NC Register
OF-010 Laboratory Monthly Gvt. STAT
OF-011 Laboratory Reports By Phone or Email
OF-012 Laboratory Quick Feedback Form
OF-013 Laboratory Incoming Phone Call Log Form
OF-014 Glucometer Calibration Data
OF-015 Training Attendance Logger
OF-016 Multiple Prick
OF-017 Test Actual Cost Calculator
OF-018 Test Amendment or Cancellation
OF-019 BCMCH Lab and Departmental Meetings Log Form
OF-020 Refrigerator Temp Log - Compartments
OF-021 Slope Monitoring
OF-022 RML QAP - Competency Evaluation
OF-023 Obsolete Files
OF-024 Drug History & Clinical Information in TRF Audit
OF-025 Laboratory Appraisal
OF-026 Laboratory Indent Receipt Record
OF-027 Laboratory Daily NC Register
OF-028 Internship, Observership Project Students entry form
OF-029 Supervisors and Managers Appraisals
OF-030 Certificate Upload
OF-031 Lab Stock Verification Form
OF-032 Lab Sub Store Stock Verification Form
OF-033 Phlebotomy OPD Work Statistics
OF-034 IP Collections Details
OF-040 Supervisors Checklist - CRL Molecular Lab
OF-041 Supervisors Checklist - Biochemistry
OF-042 Supervisors Checklist - Hematology
OF-043 Supervisors Checklist - Pathology
OF-044 Supervisors Checklist - Microbiology
OF-045 Supervisors Checklist - Phlebotomy
OF-046 Supervisors Checklist - HR & Training
OF-047 Supervisors Checklist - General
OF-048 Supervisors Checklist - Equipments
OF-049 LAB FISHBONE RCA RISK EVALUATOR FORM
OF-050 RCA Fishbone Diagram for departments
OF-051 Blue Form
OF-052 Duty Roaster
OF-053 IDSP Form
OF-054 First aid kit Content & Expiry Quarterly Monitoring Sheet
OF-055 Staff Self Reporting
OF-056 Reporting about my Staff
OF-057 Laboratory department wise budget
OF-058 Cal, Lot , ILC Verification Evaluation Sheet
4.1 Organization and management responsibility
4.2 Quality management system
4.3 Document control
4.4 Service agreements
4.5 Examination by referral laboratories
4.6 External services and supplies
4.7 Advisory services
4.8 Resolution of complaints
4.9 Identification and control of nonconformities
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement
4.13 Control of records
4.14 Evaluation and audits
4.15 Management review
5.1 Personnel
5.2 Accommodation and environmental conditions
5.3 Laboratory equipment, reagents, and consumables
5.4 Pre-examination processes
5.5 Examination processes
5.6 Ensuring quality of examination results
5.7 Post-examination processes
5.8 Reporting of results
5.9 Release of results
5.10 Laboratory information management
4 General requirements
4.1 Impartiality.
4.2 Confidentiality
4.2.1 Management of information.
4.2.2 Release of information
4.2.3 Personnel responsibility.
4.3 Requirements regarding patients.
5 Structural and governance requirements
5.1 Legal entity
5.2 Laboratory director
5.2.1 Laboratory director competence
5.2.2 Laboratory director responsibilities.
5.2.3 Delegation of duties
5.3 Laboratory activities
5.3.1 General.
5.3.2 Conformance with requirements.
5.3.3 Advisory activities
5.4 Structure and authority
5.4.1 General
5.4.2 Quality management
5.5 Objectives and policies
5.6 Risk management
6 Resource requirements
6.1 General
6.2 Personne
6.2.1 General.
6.2.2 Competence requirements
6.2.3 Authorization
6.2.4 Continuing education and professional development
6.2.5 Personnel records
6.3 Facilities and environmental conditions
6.3.1 General
6.3.2 Facility controls
6.3.3 Storage facilities
6.3.4 Personnel facilities
6.3.5 Sample collection facilities
6.4 Equipment
6.4.1 General
6.4.2 Equipment requirements
6.4.3 Equipment acceptance procedure
6.4.4 Equipment instructions for use
6.4.5 Equipment maintenance and repair
6.4.6 Equipment adverse incident reporting
6.4.7 Equipment records
6.5 Equipment calibration and metrological traceability
6.5.1 General
6.5.2 Equipment calibration
6.5.3 Metrological traceability of measurement results
6.6 Reagents and consumables
6.6.1 General
6.6.2 Reagents and consumables — Receipt and storage
6.6.3 Reagents and consumables — Acceptance testing
6.6.4 Reagents and consumables — Inventory management
6.6.5 Reagents and consumables — Instructions for use
6.6.6 Reagents and consumables — Adverse incident reporting
6.6.7 Reagents and consumables — Records
6.7 Service agreements
6.7.1 Agreements with laboratory users
6.7.2 Agreements with POCT operators
6.8 Externally provided products and services
6.8.1 General
6.8.2 Referral laboratories and consultants
6.8.3 Review and approval of externally provided products and services
7 Process requirements
7.1 General
7.2 Pre-examination processes
7.2.1 General
7.2.2 Laboratory information for patients and users
7.2.3 Requests for providing laboratory examinations
7.2.4 Primary sample collection and handling
7.2.5 Sample transportation
7.2.6 Sample receipt
7.2.7 Pre-examination handling, preparation, and storage
7.3 Examination processes
7.3.1 General
7.3.2 Verification of examination methods
7.3.3 Validation of examination methods
7.3.4 Evaluation of measurement uncertainty (MU)
7.3.5 Biological reference intervals and clinical decision limits
7.3.6 Documentation of examination procedures.
7.3.7 Ensuring the validity of examination results
7.4 Post-examination processes
7.4.1 Reporting of results
7.4.2 Post-examination handling of samples
7.5 Nonconforming work
7.6 Control of data and information management
7.6.1 General
7.6.2 Authorities and responsibilities for information management
7.6.3 Information systems management
7.6.4 Downtime plans
7.6.5 Off site management
7.7 Complaints
7.7.1 Process
7.7.2 Receipt of complaint
7.7.3 Resolution of complaint
7.8 Continuity and emergency preparedness planning
8 Management system requirements
8.1 General requirements
8.1.1 General
8.1.2 Fulfilment of management system requirements
8.1.3 Management system awareness
8.2 Management system documentation
8.2.1 General
8.2.2 Competence and quality
8.2.3 Evidence of commitment
8.2.4 Documentation
8.2.5 Personnel access
8.3 Control of management system documents
8.3.1 General
8.3.2 Control of documents
8.4 Control of records
8.4.1 Creation of records
8.4.2 Amendment of records
8.4.3 Retention of records
8.5 Actions to address risks and opportunities for improvement
8.5.1 Identification of risks and opportunities for improvement
8.5.2 Acting on risks and opportunities for improvement
8.6 Improvement
8.6.1 Continual improvement.
8.6.2 Laboratory patients, user, and personnel feedback.
8.7 Nonconformities and corrective actions
8.7.1 Actions when nonconformity occurs
8.7.2 Corrective action effectiveness
8.7.3 Records of nonconformities and corrective actions
8.8 Evaluations
8.8.1 General.
8.8.2 Quality indicators.
8.8.3 Internal audits.
8.9 Management reviews.
8.9.1 General.
8.9.2 Review input.
8.9.3 Review output
Annex A (normative) Additional requirements for Point-of-Care Testing (POCT)
Annex B (informative) Comparison between ISO 9001:2015 and ISO 15189:2022 (this document)
Annex C (informative) Comparison between ISO 15189:2012 and ISO 15189:2022 (this document)