- What are the aims and objectives of NABL?
- Where is NABL office located?
- What are the office timings of NABL?
- What is accreditation?
- Why is accreditation required?
- What are benefits of accreditation?
- How is NABL accreditation different from ISO 9000 certification?
- Can we take help from external person and/or organization (e.g. Advisor, Consultant etc.) for preparation of NABL accreditation?
- What types of CABs can seek accreditation?
- Which fields of CABs are covered by NABL?
- Why use an accredited CAB?
- How would NABL accreditation help a laboratory reach out to the global customers?
- Is accreditation a one-time phenomenon?
- Is it mandatory for laboratories to participate in Proficiency Testing programs?
- What is the process for accreditation at NABL?
- How does NABL monitor the accredited CABs?
- Who at NABL should a CAB contact for initiating the process of accreditation?
- What are the preparations required by a CAB before applying for accreditation?
- Is there a publication that can guide me through the accreditation process?
- What is Mutual Recognition Arrangements (MRA) with international bodies and what are the benefits of such arrangements for the CABs accredited by NABL?
- How can we know of the Proficiency Testing programmes?
- What training courses are offered by NABL?
- How to use NABL symbol?
- How does using an accredited CAB benefit Government and Regulators?
- How do I know a CAB is accredited by NABL?
- Why is a CAB’s technical competence so critical to you as a manufacturer, supplier, exporter or customer?
- How does NABL determine the number of assessors that will be assigned to conduct CAB’s assessment?
- What is peer evaluation?
- How long does it take for a CAB to obtain NABL accreditation?
- What is the “Scope of Accreditation”?
- How to search NABL Accredited Laboratories?
- One Person Company (OPC)?
- Limited Liability Partnership (LLP)?
- Clarification on the Role of NABL in Enforcing Regulations
1. What are the aims and objectives of NABL?
NABL is a Constituent Board of Quality Council of India. NABL has been established with the objective of providing Government, Industry Associations and Industry in general with a scheme of Conformity Assessment Body’s accreditation which involves third-party assessment of the technical competence of testing including medical and calibration laboratories, proficiency testing providers and reference material producers. The laboratory accreditation services to testing and calibration laboratories are provided in accordance with ISO/ IEC 17025 ‘General Requirements for the Competence of Testing and Calibration Laboratories’ and ISO 15189 ‘Medical laboratories — Requirements for quality and competence’. The accreditation to Proficiency testing providers is based on ISO/IEC 17043 “Conformity assessment — General requirements for proficiency testing” and to reference material producers based on ISO 17034“General requirements for the competence of reference material producers”. NABL offers accreditation services in a non-discriminatory manner. NABL has established its accreditation system in accordance with ISO/ IEC 17011 “Conformity Assessment – Requirements for Accreditation bodies accrediting conformity assessment bodies‟. NABL accreditation system also takes note of the requirements of Mutual Recognition Arrangements (MRAs) with APAC / ILAC of which NABL is a member. Return to Top
2. Where is NABL office located…?
NABL Secretariat is functioning from its office situated at NABL House, Plot No. 45, Sector-44, Gurgaon-122003, Haryana. NABL Secretariat administers and co-ordinates all activities of NABL including accreditation related activities for Testing, Calibration and Medical laboratories, Proficiency Testing Providers & Reference Material Producers. Return to Top
3. What are the office timings of NABL…?
The working days of NABL are from Monday to Friday. The office timings are from 9-00 a.m. to 5-30 p.m. Return to Top
4. What is 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. Return to Top
5. Why is accreditation required…?
Accreditation provides formal recognition of competent CABs, thus providing a ready means for customers to find reliable testing (including Medical), calibration, Proficiency Testing and Reference Material Producer services in order to meet their demands. Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. Society also needs to know the technically competent laboratory in fields such as Medical, Forensic, Food Testing etc. The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence. Return to Top
6. What are benefits of accreditation…?
BENEFITS OF ACCREDITATIONFormal recognition of competence of a conformity assessment body by NABL in accordance with international standard has many advantages:
- International recognition/ equivalence,
- Access to Global market,
- Time and money efficient,
- Enhanced customer confidence and satisfaction,
- Robust Quality Management System,
- Continual improvements,
- Better operational control,
- Assurance of accurate and reliable results,
- Cost Reduction,
- Prevent loss due to defects
BENEFITS OF LABORATORY ACCREDITATIONFormal recognition of competence of a laboratory by an Accreditation body in accordance with international criteria has many advantages:
- A ready means for customers to identify and select reliable testing, measurement and calibration services that are able to meet their needs.
- Increased confidence in Testing/ Calibration Reports issued by the testing, calibration and medical testing laboratories which emphasise on accuracy and reliable results.
- The results from accredited laboratories are used extensively by regulators for the public benefit in the provision of services that promote an unpolluted environment, safe food, clean water, energy, health and social care services.
- Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
- Helpful in participating in tenders that require independently verified laboratories.
- Users of accredited laboratories enjoy greater access for their products, in both domestic and international markets.
- Potential increase in business due to enhanced customer confidence and satisfaction: Accredited laboratories receive a form of international recognition, which allows their data and results to be more readily accepted in overseas markets. Accreditation helps to reduce costs for manufacturers and exporters who have their products or materials tested in accredited laboratories, by reducing or eliminating the need for retesting in another country.
- Customers can search and identify the laboratories accredited by NABL for their specific requirements from the NABL website 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.
BENEFITS OF ACCREDITATION OF PROFICIENCY TESTING PROVIDERS.The benefits of proficiency testing are widely recognized. These include:
- Many laboratories operate in isolation from other laboratories and do not have ongoing opportunities to compare their data with others. Without such opportunities there are risks that the data of a laboratory may have errors, biases or significant differences when compared to data from other similar laboratories. Proficiency testing provides an opportunity to undertake such comparisons and to have an independent appraisal of the laboratory’s data compared to reference values (or other performance criteria) or to the performance of similar laboratories. The results from such participation provide laboratory managers with either a confirmation that the laboratory’s performance is satisfactory or an alert that an investigation of potential problems within the laboratory is required.
- Comparison of the performance of a facility’s performance with that of other participating (peer) facilities
- Monitoring of the long-term performance of a facility.
- 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
- Contribution to the laboratories overall risk management system
- Confidence building with interested parties, e.g. customers, accreditation bodies, regulators, specifiers.
Proficiency testing providers play an important role in the value chain for assurance of products and services. Being an NABL accredited PTP in accordance with ISO/IEC 17043 gives the organization credibility for their PT services. BENEFITS OF ACCREDITATION FOR REFERENCE MATERIALS PRODUCERSFormal recognition of competence of an RMP by NABL in accordance with international criteria (ISO 17034) has many advantages like:
- Confidence in measurements by establishing traceability to appropriate measurement standards such as the use of certified reference materials (CRMs) produced by a competent producer to give a reliable physical or chemical characterization of a material.
- It 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 fit for the intended uses.
- CRMs offer a most effective means to assess the trueness and precision of a measurement process.
- Reference materials (RMs) provide one of the most effective ways of assessing and demonstrating that the measurement process is in statistical control because the homogeneity and stability of RMs have been confirmed to be suitable for use as quality control materials.
- Accreditation is a means of determining the technical competence of RMPs to produce specific RMs. It also provides formal recognition to competent RMPs, thus providing a ready means for RMs users to identify and select the most suitable RMs that meet their needs. This recognition of competence relates to the properties of the reference materials that the accredited RMP produces, and may include, if applicable, the ranges of the assigned values and their associated uncertainties. It may also include the RMPs involvement in the performance of testing, calibration and measurements in relation to homogeneity, stability and characterization assessments and their use of subcontractors in these tasks. These are the factors that RM users need to know and consider when selecting RMs
- 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 fit 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 for 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.
7.How is NABL accreditation different from ISO 9000 certification…?
ISO 9000 Certification is on Quality System Management only whereas the NABL Accreditation provides formal recognition of technical competence of the CABs, thus providing a ready means for customers to find reliable testing (including Medical), calibration, PTP and RMP services in order to meet their demands as well as the Quality system. Accreditation is a higher level activity than system certification. Laboratories can be checked and certified for their compliance to international management system standards such as ISO 9000. This involves the auditing of an organization’s quality management system. Although this will give you confidence of the laboratory’s quality system, it tells you nothing about its technical competence or its ability to provide reliable and accurate test data that will be accepted by your customers and trading partners. Proper technical evaluation requires the use of technical experts who can assess the CAB against internationally accepted criteria’s. These criteria are embraced globally in documents like ISO/IEC 17025 for Testing & Calibration laboratories, ISO 15189 for Medical laboratories, ISO/ IEC 17043 for PTP & ISO 17034 for RMP. Accreditation bodies may also apply additional technical requirements for evaluating a CAB, as per requirements of different technical fields. Accreditation against these international standards also covers the quality management system elements of ISO 9000. So NABL accreditation, which is based on these standards is a measure of both technical competence and quality management system and is the most appropriate process rather than ISO 9000 certification. Return to Top
8.Can we take help from external person and/or organization (e.g. Advisor, Consultant etc.) for preparation of NABL accreditation?
It is CAB prerogative to decide either to take help/ support from external person and/ or organization. However, NABL strongly recommends that CAB should prepare for NABL accreditation by its own. If a CAB is taking the help from external person and/ or organization, they have to mandatorily declare the same to NABL. Further, during accreditation process (either Document review or assessment) NABL does not entertain the external person. NABL officials and assessment team will interact with the CAB staff only. Return to Top
9.What types of CABs can seek accreditation…?
The CABs should be legally identifiable & appropriately registered. They can be a part of a big organization or an independent entity. NABL can provide accreditation to:
- CABs undertaking any sort of testing (including Medical), calibration, Proficiency Testing and Reference Material Production in the specified fields.
- Private or government CABs.
- Small operations to large multi-field CABs.
- Site facilities and mobile laboratories.
10. Which fields of CABs are covered by NABL…?
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|
|Electrical||Fluid Flow||Haematology & Immunohaematology|
|Electronics||Thermal||Microbiology & Infectious Disease Serology|
|Non-Destructive Testing||Medical Devices||CytoGenetics|
|Photometry||Nuclear Medicine (in-vitro tests only)|
|Diagnostic Radiology QA testing||Flow Cytometry|
|Forensic||Medical Imaging – Conformity Assessment Bodies (MI-CAB)|
|Software & IT System|
|PROFICIENCY TESTING PROVIDERS||REFERENCE MATERIAL PRODUCERS|
|Calibration||Biological & Clinical Properties|
11. Why use an accredited CAB…?
Accreditation provides a means of evaluating the competence of CABs to perform specific types of testing, measurement, calibration, run PT Scheme and produce Reference Material. It also provides feedback to CABs as to whether they are performing their work in accordance with international criteria for technical competence. Manufacturing organizations may also use CAB accreditation to enhance the testing of their products by their own in-house laboratories. Very importantly, accreditation provides formal recognition of competent CABs, thus providing a ready means for customers to find reliable testing (including Medical), calibration, Proficiency Testing services and Reference Material Producer to meet their needs. Return to Top
12. How would NABL accreditation help a CAB reach out to the global customers…?
NABL is a signatory to ILAC Arrangements as well as APAC Mutual Recognition Arrangements (MRA), based on mutual evaluation and acceptance of other MRA Partner laboratory accreditation systems. Such international arrangements facilitate acceptance of test / calibration results between countries to which MRA partners represent. This developing system of international mutual recognition agreements between accreditation bodies has enabled accredited laboratories to achieve a form of international recognition, and allowed test data accompanying exported goods to be readily accepted on overseas markets amongst the countries which have already qualified as significant to ILAC Arrangements. This effectively reduces costs for both the exporters and the importers, as it reduces or eliminates the need for products to be re-tested in another country. The information on accreditation bodies that are currently signatories to ILAC & APAC MRA is available on their respective website: http://www.ilac.org/arrangement.htmhttps://www.apac.org/apac_mra.htmlReturn to Top
13. Is accreditation a one-time phenomenon…?
NABL accreditation is not a one-time phenomenon. Once the CAB gets accredited; accreditation to a CAB shall be valid for a period of 2 years and NABL shall conduct periodical surveillance of the CAB on annual basis. CAB shall apply for renewal of accreditation to NABL at least 6 months before the expiry of the validity of accreditation. Return to Top
14. Is it mandatory for laboratories to participate in Proficiency Testing programs…?
Applicant laboratories are required to successfully participate in at least one Proficiency Testing program before grant of accreditation. Accredited laboratories are required to participate in Proficiency Testing programs covering all major areas in their scope of accreditation in a span of 2 years. In Medical testing, accredited laboratories shall participate at least one Proficiency Testing / External Quality Assurance Scheme in a year per discipline, as appropriate.
Please refer to NABL 163: Policy for participation in Proficiency testing activities available on our website (www.nabl-india.org) under Publications -> NABL Documents.
Please check the list of NABL Accredited PTPs available on our website (www.nabl-india.org)-> Proficiency testing provider -> List of accredited PTP
You may also now search for accredited PT provider under Proficiency testing Provider -> Available PT providers / program as per NABL 120 (Group / Field wise).
15. What is the process for accreditation at NABL?
- 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 100A. 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.
16.How does NABL monitor the accredited CABs?
Apart from the scheduled surveillance, NABL conducts unannounced assessment to verify the continued compliance of the CABs. The unannounced assessment is done based on random selection of CABs by an independent team of NABL that has been entrusted with the responsibility of compliance monitoring. CAB is expected to co-operate with NABL assessment team in such assessments. Accreditation of the CAB may be suspended or withdrawn in case unethical practice is observed during the unannounced assessment. Return to Top
17. Who at NABL should a CAB contact before initiating the process of accreditation…?
18. What are the 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.
19. Is there a publication that can guide me through the accreditation process…?
Document NABL 100B – ‘Accreditation Process & Procedure’ is published by NABL to guide you about NABL accreditation and its procedure. Return to Top
20. What is Mutual Recognition Arrangement (MRA) with international bodies and what are the benefits of such arrangements for the laboratories accredited by NABL…?
Many countries around the world have a formally recognized organization responsible for the accreditation of their CABs. These accreditation bodies are presently following ISO/IEC 17025 as the basis for accrediting testing and calibration laboratories; ISO 15189 for Medical testing laboratories; ISO/IEC 17043 for Proficiency Testing Providers and ISO 17034 for Reference Material Producers. Adoption of international standards has helped countries employ a uniform approach to determine CAB competence. It has also encouraged CABs to adopt internationally accepted testing and measurement practices where possible. This uniform approach allows accreditation bodies to establish arrangements between themselves through APAC and EA peer evaluation by an expert team appointed by APAC /EA MRA/MLA councils, based on mutual evaluation and acceptance of each other’s laboratory accreditation systems. Such international arrangements, called Mutual Recognition Arrangement, are crucial in enabling test data to be accepted between countries. In effect, each partner in such an agreement recognizes the other partner’s accredited CABs as if they themselves had undertaken the accreditation of the other partner’s CABs. The international mutual recognition arrangements between accreditation bodies arrived on the basis of peer-evaluation have enabled accredited CABs to achieve international recognition, and allowed test data accompanying exported goods to be readily accepted in overseas markets. This effectively reduces costs for both the exporters and the importers, as it reduces or eliminates the need for products to be re-tested in another country. NABL is a signatory to ILAC as well as APAC Mutual Recognition Arrangements (MRA) for accreditation of Testing (including Medical) and Calibration laboratories, which is based on mutual evaluation and acceptance of other MRA Partner laboratory accreditation systems. Such international arrangements facilitate acceptance of test / calibration results between countries to which MRA partners represent. Return to Top
21. How can we know of the Proficiency Testing programmes?
All NABL accredited testing and calibration laboratories are required to participate in Proficiency Testing Programmes. NABL accredits Proficiency Testing Providers (PTP) in various schemes. The detailed information is available in the section ‘Proficiency Testing Provider’ of the NABL website. Further, PT providers as per Discipline / Group wise are available on NABL website. Laboratories are also expected to participate (as far as available and practicable) in international Inter- Laboratory Comparison / Proficiency Programmes conducted by APAC, EA or equivalent organizations. This information is also mentioned in the section ‘Proficiency Testing Provider’. It is essential for all its accredited laboratories to participate in International / Regional Proficiency Testing Programmes including APAC in a manner so that all major areas of scope of accreditation are covered in a cycle of 2 years. This of course does not applies to those special areas where Inter-Laboratory Proficiency Testing Programmes are not available. Return to Top
22. What training courses are offered by NABL…?
NABL organizes training courses only to train its Assessors. Please note that the assessors training course is not an open course. The selection of experts who are to be trained as assessors is done by NABL based on current / anticipated requirements in specific field / facilities and availability of already trained assessors. Please apply for Assessor training on NABL Website (www.nabl-india.org) -> Training -> Assessors Training Course -> Introduction (http://nabl-india.org/training/assessors-training-course/introduction/) Return to Top
23. How to use NABL symbol…?
Please refer document NABL 133 –‘Policy for Use of NABL Symbol and / or Claim of Accreditation by Accredited Conformity Assessment Bodies (CAB) & NABL Accredited CAB Combined ILAC MRA Mark’. Return to Top
24. How does using an accredited CAB benefit Government and Regulators…?
Government bodies and Regulators are constantly called upon to make decisions related to:
- Protecting health and welfare of consumers and the public at large.
- Protecting the environment.
- Developing new regulations and requirements.
- Measuring compliance with regulatory and legal requirements.
- Allocating resources, both technical & financial.
Government bodies and regulators must have confidence in the data generated by NABL accredited CABs in order to make these decisions. Using an accredited CAB can help establish and assure this confidence. If a CAB is accredited, it means that the CAB has achieved a prescribed level of technical competence to perform specific types of testing (including Medical), measurement, calibration, proficiency testing services and reference materials production activities. The result is assurance that the CAB is capable of producing data that are accurate, traceable and reproducible – critical components in government decision-making. Use of accredited CAB benefits government and regulators by:
- Increasing confidence in data that are used to establish baselines for key analysis and decisions.
- Reducing uncertainties associated with decisions that affect the protection of human health and the environment.
- Increasing public confidence, because accreditation is recognizable mark of approval.
- Eliminating redundant reviews and improving the efficiency of the assessment process, which may reduce costs.
25. How do I know a CAB is accredited by NABL…?
You may search for NABL accredited CAB by visiting our website: www.nabl-india.org >> Laboratory search >> accredited labs >> Country: India >> field: Testing / Calibration / Medical / Proficiency Testing Provider / Reference Material Producer >> Discipline >> (Please click in the relevant discipline) >> group >> (please click in the relevant group) >> search. The details of CABs shall be displayed below the open menu. Click on “click here to view the scope of accreditation”. To see the scope, click on the certificate number TC/CC/MC/PC/RC-XXXX (in blue colour). Return to Top
26. Why is a CAB’s technical competence so critical to you as a manufacturer, supplier, exporter or customer…?
- Minimum risk.
- Avoid expensive re-testing.
- Enhance your customer’s confidence.
- Reduce costs and improve acceptance of your goods overseas.
27. How does NABL determine the number of assessors that will be assigned to conduct CAB’s assessment…?
The number of assessors that will be assigned to conduct CAB’s assessment will depend upon applied / accredited scope of accreditation in various fields. To conduct an assessment, NABL sends sufficient number of Technical Assessors accompanied by Lead Assessor so as to cover the entire scope of accreditation applied by the CAB. Other factors that are taken into consideration include the size of the facility and the level of measurements being made (especially in calibration). Return to Top
28. What is peer evaluation…?
The peer evaluation is the internationally accepted mechanism used to formally evaluate and recognize laboratory accreditation bodies. To obtain international recognition, NABL has had to demonstrate competency & credibility through the ‘peer evaluation’ process. Return to Top
29. How long does it take for a CAB to obtain NABL accreditation…?
The key factor in determining the time taken is the CAB’s readiness. CABs that have taken the time to prepare well for the on-site assessment and can respond quickly to assessment deficiencies can complete the process in a timely manner. NABL has all necessary resources, including staff and assessors, to accredit a well-prepared CAB in a reasonable time of about 90 days. Some CABs were able to gain accreditation faster. Return to Top
30. What is the “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. Return to Top
31. How to search NABL Accredited Laboratories…?
NABL, being an accreditation body grants accreditation to Testing and Calibration laboratories based on ISO/IEC 17025, Medical Testing- ISO 15189, Proficiency Testing Provider (PTP) – ISO 17043 and Reference Material Producers (RMP)- ISO/IEC 17034. NABL itself is not doing Testing or calibration. If you would like to test your product, then you are required to contact NABL accredited laboratory. Directory of NABL accredited laboratories are available on NABL website home page as well as website under Publications -> NABL Documents (Page 3). To search NABL accredited laboratory, please visit www.nabl-india.org. When you bring the cursor on laboratory search, a drop down will come and then click on accredited laboratory. To know the all NABL accredited testing laboratory, select field testing and click on search. The complete list will be available. Further you may also use different filter, like state and city, to locate the nearest available NABL accredited lab. In the same way, you may also search NABL accredited calibration or Medical laboratory or PTP or RMP. To find out the specific laboratory of your interest, please follow the following steps. Example 1: To find out the NABL accredited chemical testing laboratory in Gurgaon which can do water testing. Please visit www.nabl-india.org. Click on accredited laboratory under laboratory search. Select country: India Select state Haryana. Select city Gurgaon. Select field testing. Select discipline chemical. Select group water. Click on search. The details of laboratories shall be displayed. Click on “click to view the scope of Accreditation”. A new window will open. To see the complete scope of accreditation, click on the certificate number (TC-XXXX) mentioned in blue colour. The complete scope will be available for download. You may check the details of test parameters, method used by the laboratory and its capabilities in terms of range. Example 2: To find out the NABL accredited Calibration laboratory in Chennai which can calibrate 1 g weight. Please visit www.nabl-india.org. Click on accredited laboratory under laboratory search. Select Country: India Select state Tamil Nadu. Select city Chennai. Select field Calibration. Select discipline Mechanical. Select group weight. Click on search. The details of laboratories shall be displayed. Click on “click to view the scope of Accreditation”. A new window will open. To see the complete scope of accreditation, click on the certificate number (CC-XXXX) mentioned in blue colour. The complete scope will be available for download. You may check the details of test parameters, Range/ Frequency and Calibration Measurement Capability. Example 3: To find out the NABL accredited Medical testing laboratory in Kolkata for swab testing. Please visit www.nabl-india.org. Click on accredited laboratory under laboratory search. Select Country: India Select state West Bengal. Select city Kolkata. Select field Medical. Select discipline Medical. Select group Microbiology & Serology. Select subgroup Swab. Click on search. The details of laboratories shall be displayed. Click on “click to view the scope of Accreditation”. A new window will open. To see the complete scope of accreditation, click on the certificate number (MC-XXXX) mentioned in blue colour. The complete scope will be available for download. You may check the details of test parameters, test method, Range of Testing / Limits of Detection and CV %. To know the accredited PT Provider, please follow the steps as mentioned below: Please visit www.nabl-india.org. Click on accredited laboratory under laboratory search. Select Country: India Select field Proficiency Testing Provider. Click on search. The details of Proficiency Testing Provider shall be displayed. Click on “click to view the scope of Accreditation”. A new window will open. To see the complete scope of accreditation, click on the certificate number (PC-XXXX) mentioned in blue colour. The complete scope will be available for download. You may check the details of scheme, Item and Analyte/ Parameter/ Test Method. To know the accredited Reference Material Producers, please follow the steps as mentioned below: Please visit www.nabl-india.org. Click on accredited laboratory under laboratory search. Select Country: India Select field Reference Material Producers. Click on search. The details of Reference Material Producers shall be displayed. Click on “click to view the scope of Accreditation”. A new window will open. To see the complete scope of accreditation, click on the certificate number (RC-XXXX) mentioned in blue colour. The complete scope will be available for download. To find out the laboratory for specific test or test method following steps to be followed: Please visit www.nabl-india.org. Click on accredited laboratory under laboratory search. Select Country : India Type the specific test name or test method (e.g. Transmitter or IS 4671) in Looking For Keyword option. Click on search. The details of laboratories shall be displayed. Click on “click to view the scope of Accreditation”. A new window will open. To see the complete scope of accreditation, click on the certificate number (TC-XXXX) mentioned in blue colour. The complete scope will be available for download. Return to Top
32. One Person Company (OPC)
NABL has the right to exercise its due diligence in matters that safeguard its accredited CABs from falling prey to unscrupulous elements that intend to harm their interests through various acts which drain their hard-earned corpus. Thus, the business entities that are not separate from their owners are required to review their business models and convert to such a model that the liability of the legal entity is not linked with that of the person running the business. 1. What is the benefit of a One Person Company (OPC)? An OPC has features of a Company along with the benefits of a Sole Proprietorship. OPC of sole-proprietor and company form of business has been provided with concessional /relaxed requirements under the Companies Act, 2013. The liability of the proprietor is limited. OPC does not make the shareholder personally liable for the debts of the company. 2. How does OPC provide better credibility to a CAB? OPC provides a more standardized and accountable approach, corporate governance, separate personal and business assets, and facilitate better compliance with legal and financial obligations thereby reinforcing trust and confidence in CAB services such as testing, calibration, etc. 3. In what ways is OPC not related to its proprietor? OPC has a separate legal status as an entity and has distinction between owner and the business. OPC has the benefit of perpetual succession. Return to Top
33. Limited Liability Partnership (LLP)
NABL has the right to exercise its due diligence in matters that safeguard its accredited CABs from falling prey to unscrupulous elements that intend to harm their interests through various acts which drain their hard-earned corpus. Thus, the business entities that are not separate from their owners are required to review their business models and convert to such a model that the liability of the legal entity is not linked with that of the person running the business. 1. What is the benefit of a Limited Liability Partnership (LLP)? The LLP is a separate legal entity, is liable to the full extent of its assets but liability of the partners is limited to their agreed contribution in the LLP. The LLP can continue its existence irrespective of changes in partners. No partner is liable on account of the independent or un-authorized actions of other partners, thus individual partners are shielded from joint liability created by another partner’s wrongful business decisions or misconduct. 2. How does LLP provide better credibility to a CAB? LLP provides a more standardized and accountable approach, corporate governance, separate personal and business assets, and facilitate better compliance with legal and financial obligations thereby reinforcing trust and confidence in CAB services such as testing, calibration, etc. 3. In what ways is LLP not related to its partners? LLP is a separate legal entity from its partners and hence continues to exist if there is change in partners. Return to Top
Accreditation is the independent evaluation of conformity assessment bodies against recognised normative documents like standards, regulations etc. to carry out specific activities to ensure their impartiality, consistency of operation and competence. Through the application of national and international standards, government, procurers and consumers can have confidence in the results of accredited Conformity Assessment Bodies. Laboratories are accredited to the applicable international standards, ISO/IEC 17025 in case of testing and calibration laboratories, and ISO 15189 applicable to medical laboratories. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use these documents in confirming or recognizing the competence of laboratories. The results from accredited laboratories are used extensively by regulators for the public benefit in the provision of services that promote an unpolluted environment, safe food, clean water, energy, health and social care services. Many government agencies have recognised the importance of credible accreditation schemes that are developed against internationally recognised standards. NABL accreditation is increasingly being used by Regulators and Government to ascertain the quality of products. Accredited CABs can objectively state conformance of product or service to specified requirements. NABL is a voluntary accreditation body and has no regulatory powers. Checking of compliance to the regulatory requirements falls under the purview of respective/applicable regulator. In all cases, it is the responsibility of laboratory to abide by the National & State statutory requirements, Acts, Ordnance, Rules, Regulations, Legal orders, Court Decisions/ Orders issued by the Government, Statutory Bodies, Courts as applicable and in force from time to time. Return to Top