NABL Lab Testing Approval / Certification

National Accreditation Board for Testing and Calibration Laboratories (NABL)

Introduction

National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government, Industry and Society in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for Testing and Calibration laboratories.

NABL provides accreditation in all major fields of Science and Engineering such as Biological, Chemical, Electrical, Electronics, Mechanical, Fluid-Flow, Non-Destructive, Photometry, Radiological, Thermal & Forensics under testing facilities and Electro-Technical, Mechanical, Fluid Flow, Thermal, Optical & Radiological under Calibration facilities. NABL also provides accreditation for medical testing laboratories. In addition, NABL also offers accreditation for Proficiency testing providers & Reference Material producers and is now signatory to APLAC MRA for both.

Any form of laboratory or testing institution requires certification from an accredited authority in India. To comply with the norms of certification, all laboratories must follow relevant standards of quality and assessment. Any form of laboratory, medical lab, food lab, and other testing labs requires accreditation from the relevant authority. In India, the central authority for accreditation is the NABL. NABL approval is required for any form of a laboratory which has to be according to standards which are prescribed in India.

Hence NABL approval is required for any form of institution that gets into medical research, bioengineering, pharmacy, food processing and materialistic research and development (R & D).

NABL Accreditation

Accreditation is the attestation by third party with the conformity assessment body convincing the formal demonstration of its ability to hold out specific conformity assessment task. Conformity Assessment Body (CAB) does the testing which includes medical/standardisation Laboratory, Proficiency Testing supplier, Certified Reference Material Producer.

The liberalization of trade and industry policies of Government of India has created consciousness among domestic trade and providing greater thrust for export. As a consequence, testing centres and laboratories have to show the capabilities acceptable at an international level of competence.

It is a method by which the body gives recognition, based on third-party assessment and as per international standards of technical competence for specific tests/ measurements.

In the same manner Proficiency testing Provider accreditation gives formal recognition of competence for organizations that provide proficiency testing. Based on the third-party assessment Reference Material Producers Accreditation gives formal recognition of competence following international standards to carry out the production of reference materials.

Reference Material Laboratories

Laboratories that analyse different materials' reactions would also require approval from the NABL. The following reference material laboratories require this approval:

» Biological processes

» Engineering Processes

» Genetics Industry

» Pharmaceutical Industries.

Scope of NABL Accreditation

NABL Accreditation is currently being given in the following fields and disciplines. Depending upon the scope discipline belongs to the multi-disciplinary. CABs shall have to apply in relevant discipline separately. On the scope of accreditation, refer to the relevant specific criteria:

» Testing

» Calibration

» Medical

» Biological

» Photometry

» Chemical

» Radiological

» Electrical

» Electronics

» Fluid-Flow

» Mechanical

» Forensic

» Electro-Technical

» Medical Devices

» Therma

» Optical

» Clinical Pathology

» Haematology

» Immunohematology

» Microbiology & Serology

» Histopathology

» Cytopathology

» Genetics

» Nuclear Medicine (in-vitro tests only)

» Proficiency Testing Providers

» Reference Material Producers

Benefits of NABL Accreditation

Formal recognition of the ability of a laboratory by an Associate in accordance with international criteria has many advantages:

• Increased confidence in Testing/ activity Reports issued by the laboratory.

• Better management of laboratory operations and feedback as to whether or not they have technically competent and sound Quality Assurance System.

• Potential increase in business because of enhanced customer satisfaction and confidence.

• Customers will search and identify the laboratories accredited by NABL for their needs from the NABL Web-site or Directory of Authorised Laboratories.

• Users of authorised laboratories enjoy more access for their products, in both domestic and international markets.

• Savings in terms of time and cash thanks for the reduction or elimination for re-testing of product.

Eligibility Criteria for NABL Approval

To satisfy the requirement of the NABL, the institution (CAB) has to satisfy the following eligibility criteria:

• First and foremost, the institution must be a CAB carrying out relevant activities such as laboratory testing, calibration, food processing, research, and development.

• A CAB institution must either appoint a representative to start the formalities for the NABL approval process.

• The appointed representative must be aware of the existing quality processes followed by the CAB.

• The institution (CAB) must have developed a manual that indicates the quality standards. Such quality standards must satisfy the requirements of:

a) ISO/ IEC 17025: 2005; or

b) ISO 15189: 2012; or

c) ISO/IEC 17043/2010

The CAB must have an appointed manager who has relevant training up to 4 days on internal audit and management policies, which are followed.

The quality document which is prepared by the CAB must be implemented immediately. The CAB must also satisfy the criteria as required, according to NABL 130- which provides the criteria for Site testing and Site Calibration Laboratories.

Any applicant must participate in the Proficiency Training Program, which is conducted by the NABL or an international institution. If there is no form of training available, the institution can carry out an inter-lab comparison when it comes to quality assessment. If a lab wants to participate in the above event, then the minimum standard must be one parameter or one test.

The CAB must carry out at least one internal audit and management review before applying for the NABL approval.

Documents Required for NABL Approval

• NABL 112- Criteria for medical laboratories.

• NABL 126- Specific Criteria for Medical Devices Calibration.

• NABL 151 for testing laboratories.

• NABL 152 for calibration laboratories.

• NABL 153 for medical laboratories.

• NABL 155 (Application form and Check List for NABL medical).

• NABL 160 Information related to the management of the quality system manual.

• NABL 180 for PTP and.

• NABL 190 for RMP.

• NABL 100 General Information of NABL.

• NABL 219- Assessment forms and checklist for NABL (ISO/IEC 17025:2017).

• We will assist you with the procedure for NABL approval.

• Assistance with the documentation for NABL Approval.

• Types of institutions that have to apply for NABL Approval.

• End-to-end Support.

Procedure for NABL Approval

Step 1- Make an Application

In this step, the institution must make an application to the NABL. Along with the application, respective documents must be submitted to the NABL. An application must be made in triplicate (3 copies). Two copies must describe the quality manual of the management system. This must be in accordance with the requirement of the ISO/ IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034:2016.

Step 2- Payment of Fees

The applicant has to pay the respective fee, which is present under NABL 100. If an applicant does not want to make any form of information disclosures, then the same reasons must be provided to the authority.

Step 3- Receipt of Application

When the application is received by the NABL Secretariat (along with the requisite fee), a unique identification number (UIN) will be issued. The applicant must quote this number in all correspondences with the NABL.

Step 4- Pre-Assessment Visit

If there are no discrepancies in the application, then a lead assessor will be appointed to carry out a pre-assessment visit to the CAB. The assessment is carried out to understand if there are no discrepancies in the quality control adopted by the CAB. Along with this, the assessor will find out if there is any other assessment required to be carried out by the NABL.

Step 5- Submission of Report

After the evaluation is carried out by the lead assessor; a report is submitted to the Secretariat of the NABL. A copy is submitted to the Secretariat, and all the records are stored in the document management system of the Secretariat.

Step 6- Assessment Team

When the CAB has taken all the measures to correct the issues, the NABL will form a team constituted by the lead assessor, technical experts, and other individuals who are experienced in relevant fields and disciplines. The team analyses and finds out if compliance is met in accordance with the required standards. If there are any forms of discrepancies found in the CAB, then a report will be made and submitted to the Secretariat. In the report, remedies would also be included to address the discrepancies. A copy of this will be submitted to the respective CAB.

Step 7- Follow-up Action

When the NABL secretariat reviews the report, the CAB must take follow-up action. This action must be taken within 60 days of the Report of the Assessment Team. In action, the CAB must mention the corrective action it has taken to mitigate difficulties.

Step 8- Recommendations

After the follow-up action is taken by the CAB; the Accreditation Committee will make recommendations to the NABL Chairman. The Chairman's decision is not binding, and it can be appealed to the director of the NABL.

Step 9- Grant of Certificate

When the accreditation is allowed, the NABL will send the following to the applicant:

a) Unique Identification Number;

b) Certificate of NABL Approval;

c) Hologram having the NABL signs;

d) Date of Validity of the Certificate; and

e) Discipline.

Step 10- Outstanding Amount

If the applicant has any outstanding amount to pay the NABL; the same must be made before the certificate is granted to the NABL.

Step 11- Compliance

The Applicant must ensure that compliance has to be maintained. The following compliances have to be maintained by the applicant.

a) ISO/ IEC 17025: 2005; or

b) ISO 15189: 2012; or

c) ISO/IEC 17043:2010 or ISO 17034:2016.

d) Apart from this, the applicant also has to comply with the terms and conditions of the NABL 131.


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