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Laboratory Accreditation

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This post lists out the documents and records by a medical laboratory to comply with the accreditation standards from ISO15189 as well as JCI Laboratory Standards. Links to download shall be made available soon.

The basic approach for both these standards compliance in labs managed is:

  1. Quality Manual based on the respective standard
  2. Policy & Procedures to meet documentation requirements which is segregated as per the 12 Quality System Essentials.
  3. Forms, Files and Registers to be maintained (Records)

QSE 1 : Organization
Policy & Procedures:
ISO15189
– Management Review
– Ethics in Lab Medicine

JCI LAB STANDARDS

Forms/Files/Registers (ISO/JCI)
Management Review Meeting – Schedule /
Management Review Meeting – Minutes (File) /
Action Plan /


QSE 2 : Personnel
Policy & Procedures:
ISO15189
– Personnel

JCI LAB STANDARDS

Forms/Files/Registers

Annual training plan /
Training Feedback Form /
Employee training record /
Employee Performance Evaluation form /
Personnel File /
Competency Assessment /


QSE 3 : Documents and Records
Policy & Procedures:
ISO15189
– Control of Documents
– Control of Records

JCI LAB STANDARDS

Forms/Files/Registers
Annual Review Of Standard Operating Procedures /
Document Change & Approval Request Form /
Document Change Request Form /
Master List of Documents /
External Documents List /


QSE 4 : Equipment & Maintenance
Policy & Procedures:
ISO15189
– Lab Equipment & Maintenance

JCI LAB STANDARDS

Forms/Files/Registers
Equipment History Record /
Equipment Calibration Record /
Equipment file
Equipment record form
Equipment qualification and process validation
Risk assessment and risk reduction
Installation and operational qualification report
Performance qualification report
Checklist for equipment
Staff authorized for working on equipment


QSE 5 : Purchasing & Inventory
Policy & Procedures:
ISO15189
– Store
– External Services & Supplies

JCI LAB STANDARDS

Forms/Files/Registers
Purchase Indent Form
Stock Register
Order receiving and acceptance checklist
Supplier evaluation form
Supplier Review Form
Approved supplier list
Purchase order Register
Calibrator Inventory List
EQAS Inventory List
QC Inventory list
Test Reagent Inventory list
QC & Calibrator Storage chart
Consumables Issue Form


QSE 6 : Customer Service
Policy & Procedures:
ISO15189
– Resolution of Complaints
– Reception
– Review of Contract

JCI LAB STANDARDS

Forms/Files/Registers
Patient Complaints / Suggestion Form
Doctor’s Feedback Form
Evaluation of the Services provided by the Receptionist and Phlebotomist
Laboratory Test Requisition Form
Master Test List
Suggestion Form / Feedback Form
Test Amendment Form
Contract Review Checklist form


QSE 7 : Process Control
Policy & Procedures:
ISO15189
– Pre-examination Procedures
– Examination by Referral Labs
– Examination Procedures
– Method Comparison & Validation
– Assuring Quality of Examination Procedures
– Post Examination Procedures
– Reporting of Results
– Release of Results

JCI LAB STANDARDS

Forms/Files/Registers
Laboratory Test Requisition Form
Test Consent Form
Messenger Sample Collection Form
Sample Re-Work Register
Sample log Register
Specimen rejection form
Rejected sample record
Invoice to follow test register
Sample send out register
Referral sample result file
Choosing A Reference Laboratory
Checklist for Evaluation and selection of Referral Laboratories
Approved Referral Laboratories List
New Reagent Lot Verification
Biochemistry calibration plan
Proficiency testing Plan
Inter-laboratory Comparison Schedule & Plan
External Quality Control File
Checklist for monitoring of External QC Results
Validation Of Precision And Accuracy Form
Test Method validation Graph
Internal Quality Control File
Internal Quality Control – Corrective Actions file
QC & Calibrator Storage Chart
New Test Implementation
Testing Schedule
Miscellaneous test Worksheet
Sample discard & storage Register
Critical (Abnormal) Results Alert Form – Laboratory
Report Delivery Record


QSE 8 : Information Management
Policy & Procedures:
ISO15189
– Laboratory Information Management

JCI LAB STANDARDS

Forms/Files/Registers


QSE 9 : Assessment
Policy & Procedures:
ISO15189
– Internal Quality Audit

JCI LAB STANDARDS

Forms/Files/Registers
Internal Quality Audit Plan
Internal Quality Audit Schedule
IQA report
Internal Quality Audit Check List


QSE 10 : Occurrence Management
Policy & Procedures:
ISO15189
– Control of Non Conformities
– Corrective Action
– Preventive Action

JCI LAB STANDARDS

Forms/Files/Registers
Non – Conformance Report
Incident report form
Corrective Action Report
Corrective Action Summary List
Preventive Action Report


QSE 11 : Facilities & Safety
Policy & Procedures:
ISO15189
– Accommodation and Environmental Conditions
– Safety Procedure

JCI LAB STANDARDS

Forms/Files/Registers
Housekeeping File
Temperature Log Files


QSE 12 : Process Improvement
Policy & Procedures:
ISO15189
– Continual Improvement

JCI LAB STANDARDS

Forms/Files/Registers
Quality Indicator Plan
Key Performance Indicators Form
Key Performance Indicators File
Proficiency Testing Investigation


Miscellaneous Lab Posters

Sample Draw Sequence Flowchart
Sample Quality Affecting Test results
Medical Waste
Equipment labels
Order of Draw for Collection
Phlebotomy Service Flowchart

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