Diagnostic Labs Accreditation Consultants

NABL-Diagnostic Labs

Accreditation is the third party attestation related to a conformity assessment body conveying the formal demonstration of its competence to carry out specific conformity assessment task. Conformity Assessment Body (CAB) is a body which includes Testing including medical Laboratory, Calibration Laboratory, Proficiency Testing Provider, Certified Reference Material Producer.

Laboratory accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests/ measurements, based on third party assessment and following international standards.

Similarly, Proficiency testing Provider accreditation gives formal recognition of competence for organizations that provide proficiency testing. Reference Material Producers Accreditation gives formal recognition of competence to carry out the production of reference materials based on third party assessment and following international standards.

NABL grants accreditation to medical testing laboratories in accordance with ISO 15189 “Medical laboratories- requirements for quality and competence” The accreditation services to Medical Laboratories is currently given in the following disciplines:

Medical Imaging- Conformity Assessment Body (MI-CAB)

Projectional Radiography & Fluoroscopy
- X-Ray, Bone Densitometry (DEXA), Dental X-Ray-OPG, Mammography etc.
- Fluoroscopy
Computed Tomography (CT)
Magnetic Resonance Imaging (MRI)
Ultrasound and Colour Doppler
Nuclear Medicine o SPECT o PET CT o PET MRI
*Basic Diagnostic Interventional Radiology Procedures

Scope of Accreditation

The list of specific tests, types of tests or calibrations, PT Scheme, Reference Material for which a laboratory is found competent is listed in scope of accreditation along with details like test methods, ranges, CMC etc. The final content of the scope is recommended by the assessors and approved by NABL. It is very important to note that scope don’t always include all the CAB’s capabilities. This is due either to the CAB’s request to limit the scope, or because the assessors have not been able to affirm the CAB’s competency in all areas for which the CAB was seeking accreditation. Capabilities that are not listed on the scope of accreditation are not covered by the CAB’s NABL accreditation.

NABL Accreditation is currently given in the following fields and disciplines. The multi-disciplinary CABs shall have to apply in relevant discipline separately depending upon to which discipline the scope belongs.

Testing Laboratories

Calibration Laboratories

Medical Laboratories

Medical imaging-conformity Assessment bodies (MI-CAB)

Projectional Radiography & Fluoroscopy
- X-Ray, Bone Densitometry (DEXA), Dental X-Ray-OPG, Mammography etc.
- Fluoroscopy Computed Tomography (CT)
Magnetic Resonance Imaging (MRI)
Ultrasound and Colour Doppler
Nuclear Medicine
- SPECT
- PET CT
- PET MRI
*Basic Diagnostic Interventional Radiology Procedures

PROFICIENCY TESTING PROVIDERS

Testing
Calibration
Medical
Inspection

REFERENCE MATERIAL PRODUCERS

Chemical Composition
Biological & Clinical Properties
Physical Properties
Engineering Properties
Miscellaneous Properties

Process of Accreditation

The CAB is required to apply on (www.nablwp.qci.org.in) in the prescribed application form (NABL 151 for testing laboratories, NABL 152 for calibration laboratories, NABL 153 for medical laboratories, NABL 180 for Proficiency Testing Providers (PTP), NABL 190 for Reference Material Producers (RMP), NABL 154 for Integrated Assessment of Testing Laboratories, NABL 155 for NABL Medical (Entry Level) Testing labs and NABL 156 for Medical Imaging – Conformity Assessment Bodies) along with the system document (howsoever named eg quality manual) of the CAB that should describe the management system in accordance with ISO/ IEC 17025 or ISO 15189 or ISO/IEC 17043 or ISO 17034 whichever is applicable. The application is to be accompanied with the prescribed application fee as detailed in NABL 100. CAB has to take special care in filling the scope of accreditation for which the CAB wishes to apply. In case, the CAB finds any clause (in part or full) not applicable to the CAB, it is expected to furnish the reasons.
NABL Secretariat on receipt of application form, the quality manual and the fees issues an acknowledgement to the CAB indicating a unique ID number, which is used for correspondence with the CAB. After scrutiny of application for its completeness in all respects, NABL Secretariat may ask for additional information/ clarification(s), if necessary.
In case there are no inadequacies in the quality manual or after satisfactory corrective action by the CAB, an optional pre -assessment visit of the CAB is organised by lead assessor appointed by NABL. The pre-assessment of the CAB is conducted to evaluate non-conformities (if any) in the implementation of the quality system, to assess the degree of preparedness of the CAB for the assessment, to determine the number of assessors required in various fields based on the scope of accreditation, number of key location to be visited etc. The lead assessor submits a pre-assessment report to NABL Secretariat with a copy to the CAB. The CAB takes corrective actions on the non- conformities raised on the documented management system and its implementation and submits a report to NABL Secretariat.
After the CAB has taken satisfactory corrective actions, NABL finalizes the constitution of assessment team in consultation with the CAB. The team includes the lead assessor and technical assessor(s)/ expert(s) in order to cover various fields/ disciplines/ groups within the scope of accreditation sought. NABL may also nominate an observer. The assessment team reviews the CAB’s documented management system and verifies its compliance with the requirements of ISO/ IEC 17025 or ISO 15189 or ISO/IEC 17043 or ISO 17034 whichever is applicable and relevant specific criteria and other NABL policies. The CAB’s technical competence to perform specific tasks is also evaluated. The non- conformities if identified are reported in the assessment report. It also provides a recommendation towards grant of accreditation or otherwise. The report prepared by the assessment team is sent to NABL Secretariat. However a copy of summary of assessment report and copies of non-conformities if any, are provided to the CAB at the end of the assessment visit.
The assessment report is examined by NABL Secretariat and follow up action as required is initiated. CAB has to take necessary corrective action on non-conformities and submit a report to NABL Secretariat within 30 days. NABL monitors the progress of closing of non-conformities.
After satisfactory corrective action by the CAB, the Accreditation Committee examines the assessment report, additional information received from the CAB and the consequent verification, if any. In case everything is in order, the Accreditation Committee makes appropriate recommendations regarding accreditation of the CAB to the CEO, NABL.
All decision taken by NABL are open to appeal by the CAB. The appeal is to be addressed to the CEO, NABL.
When the recommendation results in the grant of accreditation, NABL issues an accreditation certificate which has a unique number (TC-XXXX for testing laboratories, CC-XXXX for calibration laboratories, MC-XXXX for medical laboratories, PC-XXXX for Proficiency Testing Providers, RC-XXXX for Reference Material Producers) and NABL QR code, discipline, date of validity along with the scope of accreditation.
For site laboratory, tests/ calibrations performed at site are clearly identified in the scope of accreditation while issuing the certificate.
The applicant CAB must make all payments due to NABL, before the accreditation certificate(s) is/ are issued to them.
The accredited CABs at all times shall conform to the requirements of ISO/ IEC 17025 or ISO 15189 or ISO/IEC 17043 or ISO 17034 whichever is applicable and relevant specific criteria and NABL Policies. The accredited CABs are required to comply at all times with the terms and conditions of NABL given in NABL 131 “Terms & Conditions for obtaining and maintaining NABL Accreditation‟.
The NABL accreditation certificate is valid for a period of 2 years. NABL conducts annual Surveillance of the CAB at intervals of one year which is aimed at evaluating continued compliance to the requirements of ISO/ IEC 17025 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034: 2016 whichever is applicable and relevant specific criteria and NABL Policies.
The accredited CAB is subjected to re-assessment every 2 years. The CAB has to apply 6 months before the expiry of accreditation to allow NABL to organise assessment of the CAB, so that the continuity of the accreditation status is maintained.

Preparations required by a CAB before applying for accreditation

Once the CAB decides to seek NABL accreditation, it should make a definite plan of action for obtaining accreditation and nominate a responsible person to co-ordinate all activities related to seeking accreditation who should be familiar with CAB’s existing quality system.
The CAB should get fully acquainted with relevant NABL documents and understand the assessment procedure and methodology for filing an application.
A CAB wishing to be accredited by NABL must have a Quality Manual on its Quality System satisfying the requirements as described in various clauses of ISO/ IEC 17025 or ISO 15189 or ISO/IEC 17043 or ISO 17034 whichever is relevant and requirements of relevant NABL specific criteria and needs to ascertain the status of its existing quality system and technical competence.
The competence of the proposed Quality manager on relevant standard shall be adjudged during the assessment.
The CAB must ensure that the procedures described in the Quality Manual and other documents are being implemented. In case the laboratory performs site testing/ calibration, it must also comply with NABL 130 “Specific criteria for site testing and site calibration laboratories.
The applicant CAB must have participated satisfactorily in the proficiency testing program, wherever applicable, conducted by NABL/ APAC or any other national or international accredited/ recognised PT provider. If no suitable PT program is available the CAB can initiate an inter-laboratory comparison with adequate number of accredited laboratories. The minimum stipulated participation for laboratories is one parameter/ type of test/ calibration per discipline, prior to grant of accreditation and an on-going program as per NABL 163. The satisfactory performance shall be defined in term of z-score and En number respectively or any other acceptable internationally accepted method. For unsatisfactory performance, the CAB is to take corrective action and inform NABL. ISO/ IEC 17043, NABL 163 and NABL 164 give details of proficiency testing.
The applicant CAB must have conducted at least one internal audit and a management review before the submission of application.

Application for Accreditation

CABs are required to apply through NABL Web Portal (through website www.nabl-india.org) to NABL in prescribed application form (NABL 151, NABL 152, NABL 153) for Testing including Medical along with associated Sample Collection Centre/ Facilities (SCF) / Calibration Laboratories which should describe the management system in accordance with ISO/IEC 17025: 2017 or ISO 15189: 2012. The application fees shall be accompanied with prescribed application fee as detailed in NABL 100.

CABs seeking accreditation for Medical Imaging- Conformity Assessment Body (MI-CAB) as per ISO 15189:2012, are required to apply in prescribed application form NABL 156.

However, CABs are required to apply to NABL in prescribed application form (NABL 180 and NABL 190) for Proficiency Testing Providers & Reference Material Producers in one copy along with one copy of the Manual of the CAB which should describe the management system in accordance with ISO/IEC 17043: 2010 or ISO 17034: 2016 whichever is applicable. The application shall be accompanied with prescribed application fee as detailed in NABL 100. A signed copy of NABL 131 shall also be submitted along with the application.

Acknowledgement and Registration of Application

NABL Secretariat through Web Portal, on receipt of online application form along with Management system document / quality manual and the fees, send an acknowledgement with a unique ID number to the CAB. The unique ID of the CAB will be used for further correspondence with the CAB. After scrutiny of application for its completeness in all respects, NABL Secretariat may ask for additional information/ clarification(s) at this stage, if found necessary.

Appointment of Lead Assessor

NABL secretariat appoints a Lead assessor from the list of empanelled assessors. The lead assessor does the document review on behalf of NABL and submits the report to NABL secretariat.

Document Review

The preliminary document review of the application and management system document

Accreditation Procedures

quality manual submitted by the CAB is carried out by NABL Secretariat whereas the detailed review is carried out by Lead Assessor. The lead assessor informs NABL regarding the document review, indicating inadequacies (if any). The CAB amends the relevant documents and also implements the management system accordingly.

Pre-Assessment

In case there are no inadequacies in the document review after satisfactory corrective action by the CAB, a pre -assessment of the CAB is conducted by lead assessor appointed by NABL. Since Pre-assessment is optional, CAB shall express its willingness in writing to undergo the same. The CAB must ensure their preparedness by carrying out an internal audit and a management review before the pre -assessment.

The pre-assessment of the CAB is conducted to:

evaluate non-conformities (if any) in the implementation of the quality system.
assess the degree of preparedness of the CAB for the assessment
determine the number of assessors required in various fields based on the scope of accreditation, number of key locations to be visited etc.

The lead assessor submits a pre-assessment report to NABL Secretariat with a copy to the CAB. The CAB takes corrective actions on the non-conformities raised on the documented

management system and its implementation and submits a report to NABL Secretariat.

Assessment

After the CAB has taken corrective actions, NABL proposes constitution of an assessment team. The team includes the lead assessor (generally same who is already appointed for preassessment), the technical assessor(s)/ expert(s) in order to cover various fields within the scope of accreditation sought. NABL may also nominate an observer. NABL seeks CAB’s acceptance for the proposed assessment team and the CAB is free not to accept one or more members of the proposed assessment team by giving specific reason(s) for their non –acceptance.

After the constitution of assessment team is finalized, NABL fixes dates for on-site assessment in consultation with the CAB, the lead assessor and technical assessor(s)/ expert(s).

The assessment team reviews the CAB ’s documented management system and verifies its compliance with the requirements of ISO/ IEC 17025: 2005/ ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016 whichever is applicable and relevant specific criteria (wherever applicable) and other NABL policies. The documented Management system, SOPs, work instructions, test methods etc. are assessed for their implementation and effectiveness. The CAB’s technical competence to perform specific tasks is also evaluated.

The assessment report contains the evaluation of technical manpower, all relevant material examined, test witnessed including those of replicate testing/ measurement, compliance to ISO/ IEC 17025: 2005/ ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016 whichever is applicable and relevant NABL specific criteria. The nonconformities if identified are reported in the assessment report. It also provides a recommendation towards grant of accreditation or otherwise. The report prepared by the assessment team is sent to NABL Secretariat. However, a copy of summary of assessment report and copies of non-conformities if any, are provided to the CAB at the end of the assessment visit. Assessment of each declared Sample Collection Centre/ Facility (SCF) of a medical laboratory will be done in each accreditation cycle. This may be done along with assessment of the laboratory or separately as the case may be.

Scrutiny of Assessment Report

The assessment report is examined by NABL Secretariat and follow up action as required is initiated. CAB has to take necessary corrective action on non – conformities/ concerns and submit a report to NABL Secretariat within 30 days. NABL monitors the progress of closing of non -conformities. If any non-conformity is observed during the assessment of a Sample Collection Centre/ facility (SCF), the laboratory shall be asked to take corrective actions within 30 days time. In case the laboratory fails to take corrective actions or there is a consistent system failure, an appropriate and proportionate action against the laboratory will be taken.

Accreditation Committee

After satisfactory corrective action by the CAB, the Accreditation Committee examines the assessment report, additional information received from the CAB and the consequent verification, if any.

In case the Accreditation Committee finds deficiencies in the assessment report, the NABL Secretariat obtains clarification from the Lead Assessor/ Assessor/ CAB concerned. In case everything is in order, the Accreditation Committee makes appropriate recommendations regarding accreditation of the CAB to the Chairman, NABL. All decisions taken by NABL regarding grant of accreditation are open to appeal by the CAB. The appeal is to be addressed to the CEO, NABL.

Issue of Accreditation Certificate

When the recommendation results in the grant of accreditation, NABL issues an accreditation certificate which has a unique number and QR Code, discipline, date of validity along with the scope of accreditation. The scope of accreditation for testing laboratory defines Discipline/ Group, materials or products tested component, parameter or characteristic tested and Tests or Type of tests performed and, where appropriate, the techniques, methods and / or equipment used. The scope of accreditation for calibration laboratory defines Discipline/ Group, Measurand or reference material, type of instrument or material to be calibrated or measured, and Calibration or measurement method or procedure and Measurement range & additional parameters where applicable and CMC in terms of Measurement uncertainty.The scope of accreditation for medical laboratory defines Discipline/ Group, Materials or products tested component, Parameter or characteristic tested and Tests or type of tests performed and, where appropriate, the techniques, methods and / or equipment used. The annexure to theaccreditation certificate will also contain the details of recognized Sample Collection Centres / Facilities associated.
The scope of accreditation for proficiency testing provider defines Proficiency Testing scheme/ Type of Proficiency testing item / Matrix and Measurand (s) or characteristic or type of measurand or type of characteristic or analyte or parameter.

Quality Assurance Scheme for Basic Composite Medical Laboratories (Entry Level)

For sensitizing the laboratories performing basic testing to quality practices and access to quality health care for the majority of citizens especially those residing in villages, small towns, NABL has launched voluntary scheme namely Quality Assurance Scheme for Basic Composite Medical Laboratories (Entry Level). The criteria is based on the requirements enlisted in Gazette notification dated 18th May, 2018 by MoHFW to amend Clinical Establishments (Central Government) Rules, 2012. Components of competence assessment have been added for assuring Quality and validity of test results. This scheme of Basic Composite Medical Laboratories (Entry Level) is an independent quality assurance scheme, which is not covered under APAC & ILAC MRA. Interested laboratories are required to submit application and undergo third party assessment by NABL. The assessment process is based on the checklist. Laboratories are required to pay towards application fee, assessment charges and annual membership fee (Please refer section of ‘NABL Finance and Fee Structures’ of this document for details). The laboratories will be recognized for a period of three years. It is desired that subsequently the laboratories achieve accreditation as per ISO 15189.

Maintaining Accreditation

Conformance to Applicable standards and NABL requirements

The accredited laboratories at all times shall conform to the requirements of ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016 whichever is applicable and relevant specific criteria (wherever applicable) and NABL Policies.

NABL Terms and Conditions

The accredited CABs are required to comply at all times with the terms and conditions of NABL given in NABL 131 ‘Terms & Conditions for obtaining and maintaining NABL Accreditation’. The CABs are required to submit a signed copy of NABL 131 indicating their willingness to abide by the terms and conditions given in NABL 131.

Modifications to the Accreditation Criteria

If the accreditation criteria are modified by ISO/ ILAC/ APAC/ NABL, the CAB is informed of this giving a transition period of at least 6 months to align its operations in accordance with the modified criteria.

Adverse decision against the laboratories

If the CAB at any point of time does not conform to the applicable standards and NABL criteria; or does not maintain the NABL terms and conditions; or is not able to align itself to the modified criteria, NABL may take adverse decision against the CAB like denial of accreditation, scope reduction, abeyance, suspension or forced withdrawal. NABL 216 ‘Procedure for dealing with adverse decisions’ gives the details.

Surveillance and Re-assessment

NABL applies an assessment programme comprising of annual desktop surveillance during each accreditation cycle of 2 years. At the end of the accreditation cycle, an on-site reassessment is conducted covering representative scope of accreditation. The NABL accreditation certificate is valid for a period of 2 years. NABL conducts annual Desktop Surveillance which is aimed at evaluating continued compliance with ISO/IEC 17025:2005 or ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016 whichever is applicable and relevant NABL specific criteria (wherever applicable) and Policies. The types of assessments are given below:

Desktop Surveillance

The desktop surveillance consists of calling of records from the CAB to ascertain that the CAB continues to maintain the requirements of ISO/IEC 17025:2005 or ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016 whichever are applicable and relevant NABL specific criteria (wherever applicable). NABL conducts annual desktop surveillance during each accreditation cycle of 2 years.

Reassessment

The accredited CAB is subjected to re-assessment every 2 years. The CAB has to apply 6 months before the expiry of accreditation to allow NABL to organize assessment of the CAB, so that the continuity of the accreditation status is maintained. The renewal application is submitted in the prescribed form (NABL 151/ NABL 152/ NABL 153/ NABL180/ NABL190) in three copies along with two copies of Quality Manual of the CAB which describes the latest management system in accordance with ISO/IEC 17025:2017 or ISO 15189: 2012 or ISO/IEC 17043:2010, ISO 17034:2016 whichever is applicable. The application is to be accompanied by the prescribed renewal fee, as detailed in the application form. The CAB may request extension to the scope of accreditation, which should explicitly be mentioned in the application form.