Why Accreditation ?
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.
The liberalization of trade and industry policies of the Government of India has created quality consciousness in domestic trade and provided greater thrust for export. As a consequence testing centres and laboratories have to demonstrably operate at an internationally acceptable level of competence.
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.
Benefits of Accreditation
Formal recognition of competence of a laboratory by an Accreditation body in accordance with international criteria has many advantages:
- Increased confidence in Testing/ Calibration Reports issued by the laboratory
- Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent
- Potential increase in business due to enhanced customer confidence and satisfaction.
- Customers can search and identify the laboratories accredited by NABL for their specific requirements from the NABL Web-site or Directory of Accredited Laboratories
- Users of accredited laboratories enjoy greater access for their products, in both domestic and international markets.
- Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
Proficiency testing providers play an important role in the value chain for assurance of products and services. Being an accredited PTP gives the organisation credibility for their PT services. The benefits of proficiency testing are widely recognized. These include:
- Comparison of a facility’s performance with that of other participating (peer) facilities
- Monitoring of a long-term facility performance
- Improvement in the performance of tests/calibrations following investigation and identification of the cause(s) of unsatisfactory PT performance, and the introduction of corrective action to prevent re-occurrence
- Staff education, training and competence monitoring
- Evaluation of methods, including the establishment of method precision and accuracy
- Estimation of measurement uncertainty
- Contribution to the facility’s overall risk management system
- Confidence building with interested parties, e.g. customers, accreditation bodies, regulators.
Formal recognition of competence of a RMP by an Accreditation body in accordance with international criteria has many advantages:
- Accreditation is an effective marketing tool for RMPs.
- Accreditation provides assurance that the accredited RMPs are competent to produce the RMs as listed in the scope of accreditation.
- It provides confidence to RM users that the reference materials (RMs), and certified reference materials (CRMs) in particular, are produced according to technically valid and internationally recognized principles, and fitted for the intended uses.
- These uses include the assessment of precision and trueness of measurement methods, quality control, assigning values to materials, calibration, and the establishment of conventional scales. This eliminates the needs of the users to evaluate the quality of the RMs themselves.
- RMs are used globally. Many economies around the world have accreditation bodies offering accreditation to RMPs. These accreditation bodies have adopted ISO 17034: 2016 as the criteria for RMP accreditation. This has helped economies to adopt a uniform approach to determining RMP competence. This uniform approach allows accreditation bodies in different economies to establish arrangements among themselves, based on mutual evaluation and acceptance of each other’s RMP accreditation systems.
Scope of 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. For more details on scope of accreditation please refer the relevant specific criteria.
|TESTING LABORATORIES||CALIBRATION LABORATORIES||MEDICAL LABORATORIES|
· Non-Destructive Testing (NDT)
· Diagnostic Radiology QA Testing
· Software & IT System
· Fluid Flow
. Medical Devices
|· Clinical Biochemistry
· Clinical Pathology
· Haematology & Immunohematology
· Microbiology & Infectious Disease Serology
· Flow Cytometry
MEDICAL IMAGING-CONFORMITY ASSESSMENT BODIES (MI-CAB)
· Projectional Radiography & Fluoroscopy
a. X-Ray, Bone Densitometry (DEXA), Dental X-Ray-OPG, Mammography etc.
· Computed Tomography (CT)
· Magnetic Resonance Imaging (MRI)
· Ultrasound and Colour Doppler
· Nuclear Medicine
b. PET CT
c. PET MRI
· *Basic Diagnostic Interventional Radiology Procedures
(Image guided Core Biopsy and/or Needle Aspiration eg. Fine Needle Aspiration Cytology)
*for only such IR procedures that will be carried out by Radiologists.
|PROFICIENCY TESTING PROVIDERS||REFERENCE MATERIAL
|· Chemical Composition
· Biological & Clinical Properties
· Physical Properties
· Engineering Properties
· Miscellaneous Properties
Preparation & Eligibility 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 System Document Quality Manual on its Quality System satisfying the requirements as described in various clauses of ISO/ IEC 17025:2017 or ISO 15189:2012 or ISO/IEC 17043:2010 or ISO 17034: 2016 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 proposed person responsible for quality system or Quality manager shall have undergone 4-days formal training on management system and internal audit based on relevant standard.
- 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/ APLAC 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.
Process of Accreditation
- The CAB is required to apply in the prescribed application form (NABL 151 for testing laboratories, NABL 152 for calibration laboratories, NABL 153 for medical laboratories, NABL 180 for PTP and NABL 190 for RMP), in three copies along with two copies of the quality manual of the CAB that should describe the management system in accordance with ISO/ IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034: 2016 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, a 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: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034: 2016 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 60 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 Chairman, NABL.
- All decision taken by NABL are open to appeal by the CAB. The appeal is to be addressed to the Director, NABL.
- When the recommendation results in the grant of accreditation, NABL issues an accreditation certificate which has an unique number and NABL hologram, 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: 2005 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 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: 2005 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.
Modifications to the Accreditation Criteria
If the accreditation criteria are modified by ISO/ ILAC/ APLAC/ 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 CABs
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 as per NABL 216 “Procedure for dealing with adverse decisions‟.
Complaints & Appeals
NABL is open to receiving complaints for any of the activities performed by its officials, assessors, accreditation committee members and the accredited CABs. The details are provided in NABL 132 “Procedure for Dealing with Complaints”.
NABL is open to appeals from the CABs against its decisions. The details are provided in NABL 134 “Procedure for Dealing with Appeals against Adverse Decisions Taken by NABL”.