NATIONAL ACCREDITATION BOARD FOR
TESTING & CALIBRATION LABORATORIES
Dr. Susmita Bose Roy
NABL
• National Accreditation Board for Testing and
Calibration Laboratories
• Under QCI of Government of India
• The accreditation to testing and Calibration
laboratories are granted in accordance with ISO/IEC
17025: 2005 and medical testing as per ISO
15189:2003.
General information
• NABL web site www.nabl-india.org/
• How to find ISO 15189:2007
https://www.iso.org/standard/42641.html
• How to find ISO 15189:2012
https://www.iso.org/standard/56115.html
• How to find NABL-112
www.nabl- india.org/nabl/file_download.php?
filename=201207131010-NABL-112...
How to find NABL Document
www.nabl-india.org/
Publication(home page)
NABL document
(all list )
153 Application form for medical testing
laboratories
208 Pre-Assessment Guidelines & forms
ISO(International organization for
standardization) of Different category
• ISO15189 - How to Manage Quality of
Medical Laboratories
• ISO9000 - Definition of Quality Management
• ISO9001 - How to Manage Quality of Any
System
• ISO17025 - How to Manage Quality of
Testing & Calibration of Laboratories
Full forms
1. QCI – Quality Council of India
2. NABL – National Accreditation board for testing and
calibration laboratories.
3. NABH - National Accreditation board for hospitals and health
care providers.
4. MRA – Mutual Recognition Agreement
5. ILAC – International laboratory accreditation cooperation.
6. APLAC – Asia pacific laboratory accreditation cooperation.
7. LIS – laboratory information science.
8. IQC – Internal quality control.
9. EQAS – External quality assurance scheme.
10. ILC – Inter Laboratory Comparison
11. ISO – International organization for standardization
13. IEC – International electro-technical commission.
14. WDI – Work Desk Instruction
15. SOP – Standard operating procedures.
16. TRF – Test Request Form
17. TAT – Turn around time.
18. CLIA – clinical laboratory improvement amendment.
19. CLSI – clinical and laboratory standards institute.
20. CV – Coefficient of variation
21. SD – Standard Deviation
22. TE - Total Error
23. TAE – Total Allowable Error
24. CAB – Conformity Assessment Bodies
25. QM- Quality manager
26. TM- Technical manager
27. LD- Laboratory director.
Scope of NABL Accreditation
• Testing laboratories
• Calibration laboratories
• Medical laboratories
Calibration laboratories
•Electro-Technical – Electric current, magnetic field
•Mechanical – Speed , Rotation
•Radiological – X rays illustration management
•Thermal – Temperature
•Optical – light wave length
•Fluid-Flow – flow rate
Medical laboratories
• Clinical Biochemistry
• Clinical Pathology
• Genetics
• Cytopathology
• Hematology & Immuno-haematology
• Histopathology
• Microbiology& Serology
• Nuclear Medicine (only in-vitro tests)
THE INTERNATIONAL PICTURE
Mutual Recognition Agreement
• ISO (ILAC), APLAC and NABL are interconnected.
• ISO,APLAC,NATA & NABL linked to the same
standardization (ISO) in testing procedures.
• MRA indicate synchronization of standard requirement
between all bodies.
• Example….
• ISO – laboratory personnel should be competent for
intended purpose.
• NABL – MLT , B.Sc. , M.Sc
• NATA - depend on their respective country criteria.
Information About Laboratory Required by
NABL
• Testing / Calibration / Medical
• Full time / Part time
• Fixed / Mobile
• Legal identity / status /registration
• Name of the CAB
BENEFITS OF
ACCREDITATION
LABORATORY
Use of NABL symbol
The accredited laboratories can issue test reports
bearing the accreditation body’s symbol or
endorsement, as an indication of accreditation.
International Recognition
Lab accreditation is highly regarded both nationally
and internationally as an indicator of technical
competence
Satisfaction of the staff
The staff in an accredited laboratory is satisfied as it
provides for continuous learning ,good working
environment, leadership.
BENEFITS OF ACCREDITATION
LABORATORY
Continuous improvement
Accreditation to a laboratory stimulates continuous
improvement .It enables the laboratory in demonstrating
commitment to quality test reports.
Systematic Control of lab work
Better control of laboratory operations and feedback to
laboratories
Benchmark with best laboratories
It also provides opportunity to the laboratory to benchmark
with the best
Rise in business
There is marked increase in the business of the labs as the
accredited status can be seen by the clients on NABL website.
Preparation of CAB before applying for
NABL Accreditation
• Appoint quality manager who has done “Internal
Auditor Course as per ISO:15189:2012.”
• Designate QM.
• EQAS & IQC for all parameters
• Prepare quality manual and quality system manual
• Preparing SOP and WDI related to different
process
• Training for all laboratory personnel.
ACCREDITATION PROCESS
ACCREDITATION PROCESS
Application for Accreditation
(by Laboratory)
Acknowledgement & Scrutiny of Feedback
Application
to
(by NABL Secretariat)
Adequacy of Quality
) Manual Laboratory
(by Lead Assessor)
Pre-Assessment of Laboratory and
(by Lead Assessor)
Final Assessment of Laboratory Necessary
Corrective
(by Assessment Team)
Scrutiny of Assessment Report Action
by
(by NABL Secretariat)
Recommendations for Accreditation Laboratory
(by Accreditation Committee)
Approval for Accreditation
(( by Chairman NABL)
Issue of Accreditation Certificate
(by NABL Secretariat)
Accreditation Certificate
Other definitions
Accreditation
•Procedure by which an authoritative body (NABL) gives
formal recognition that an organization (Laboratory)is
competent to carry out specific tasks .
Quality
•Degree of fulfillment of specific characteristic with specific
criteria.
•For Glucose, Total allowable error as per CLIA is <10%
•Biochemistry laboratory has TE of 5% for glucose
Quality Management System
•QMS is to direct and control an organization to maintain quality.
•It is document to control and direct all process like the pre-
examination, examination and post-examination processes.
Quality policy
•Overall intentions and direction of a laboratory related to
quality
•Formal promise
•“New Civil Hospital Laboratory Services Surat” (NCHSLS) is
committed to provide accurate, reliable and timely medical
laboratory services.
Inter laboratory comparison
•To compare test value with other laboratory to check
performance and evolution.
•For example,
Compare Glucose value with SMIMER hospital
laboratory.
Randox EQAS programme
In this programme more than 1000 laboratory participate.
Laboratory reports is compare with all this laboratories .
CAL less_than 6.5
Critical interval
•Interval of examination CHE less_than 3000
results for test that
indicates an immediate GLC less_than 55
risk to the patient.
GLC less_than 30
IBIL more_than 15
K less_than 3
K more_than 5.5
TBIL more_than 15
Biological reference interval or Reference interval
•specified interval of values taken from a biological reference
population.
•For example, RBS reference interval = 70-140 mg/dl,
Abnormal RBS = > 140 mg/dl,
Critical RBS = > 300 mg/dl.
Documented procedure
• Documentation of specified way to carry out any activity or a
process.
•For example, documentary procedure for performing ADA test.
Nonconformity
•Nonfulfillment of a requirement
•For example,
Internal quality control value for Glucose goes out of 3 SD.
Laboratory technician got needle pick injury during blood
collection.
Point-of-care testing (POCT)
•Near-patient testing
•Testing performed near or at the site of a patient
• Example : Glucometer
Clauses & Sub clauses
4.1 Organization and management
• Guideline about
– legal identity
– registration of organization
– ethical issues
– responsibility of different laboratory person.
4.2 Quality management system
• What to write QMS.
– document, procedure, WDI,
• Organization chart
4.3 Document Control
• Labeling and identification of different document.
• all documents are identify to include,
– A title,
– a unique identifier on each page;
– The date of current edition and/or edition number
– Page number to total number
– Authority of issue.
4.4 Review of contracts.
• It is related to agreement with customer(patient), user
and doctor.
– Which test can be done or not done
– Which procedure
– when report available = TAT
– how report will be available.
4.5 Examination by referral laboratories
• About selection and evolution of referral laboratory.
4.6 External services and supplies
• Procedure for how to purchase equipment, consumable
reagents.
4.7 Advisory services
• About interpretation of result, scientific review.
4.8 Resolution of complains
• Procedure to respond complain and feedback.
4.9 Identification and control of nonconformities(refusal)
Procedure for identification and immediate action , corrective
action, preventive action and authorized person to response NC.
4.10 Corrective action
• To eliminate cause of nonconformities.
4.11 Preventive action
• For prevention of nonconformities.
4.12 Continual improvement
• Add new test, decrease TAT, improve techniques,
improvement more specific result.
4.13 Quality and technical records
records shall include at least the following;
• Staff qualifications, training and competency records;
• Request for examination
• Records of receipt of samples in the laboratory
• Examination results and reports;
• Instrument maintenance records,
• Calibration functions and conversion factors;
• Quality control records;
• Nonconformities identified and immediate or corrective
action taken;
• Complaints and action taken;
• Records of internal and external audits;
• Interlaboratory comparisons of examination results;
4.14 Evaluation & Audits
1. Plan & implement to the internal audits
2. Patient& doctors feedback
3. Staff suggestion
4. Internal Audit
1. Self evaluation of laboratory about technical and management requirement as per
ISO 15189:2012 & NABL 112
5. Risk management
6. Quality indications
1. IQC & EQAS
2. TAT
3. Sample flow
7. Reviews by external organization
4.15 Management review
• Management meet with N.C. related to management
• Role of management to resolve this N.C.
• Discussion about Risk management & Continueal improvement
Technical requirements
5.1 Personnel
• Personal qualification
• The laboratory provide training for all personnel :
– The quality management system;
– Assigned work processes and procedure;
– The applicable laboratory information system;(LIS)
– Heath and safety, including the prevention or containment
of the effects of adverse incidents;
• Needle pick injury
• BMW management training
• Mercury spillage as well as sample spillage
• Fire extinguisher training
– Ethics;
– Confidentiality of patient information.
5.2 Accommodation and environmental
condition
• Staff facility
• Patient facility
• Testing facility
• Storage facility
• Disposal facility
5.3 Laboratory equipments, reagents and
consumables.
5.3.1. equipment
- calibration
- maintenance
5.3.2. reagents and consumer
- verification
- validation
- inventory
- storage.
5.4 Pre-examination procedures
• Request form
• Primary collection manual
– Information of patient & users during sample collection.
– Sample collection
– Sample transport
– Sample reception
5.5 Examination procedure
• About examination procedures.
5.6 Assuring quality of examination procedure
• Related to frequency of IQC and EQAS
• Drawing of L J chart
• Interpretation of L J chart
• Interpretation of ILC
• Root cause analysis of IQC & EQAS
5.7 Post-examination procedures
• About review of results
• Storage, retention and disposal of sample.
5.8 Reporting of results
• identification of the examination
• identification of the laboratory .
• identification of all examinations done by referral laboratory
• patient identification and location
• Date of primary sample collection
• type of primary sample;
• Name of procedure,
• Results SI units
• biological reference range
• interpretation of results
• Authorized signature
• date of the report, and time of release
• page number
5.9 Release of results
Technical personnel shall be well trained.
Issues a final report after verifying Results of the
tests.
Reports records should be maintain for revise.
5.10 Laboratory information management
Patients security and confidentiality maintain
Access to LIS should be restricted.
