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NABL License

Are you running a medical laboratory, food laboratory, or any other testing institution in India? If so, you need to comply with the certification standards prescribed in the country and acquire a National Accreditation Board for Testing and Calibration Laboratories (NABL) license. This certification is necessary for any laboratory to operate legally in India, and it ensures quality and technical competence when performing tests and calibration. In this blog post, we will explore the importance of NABL license in India and how Shamkris Group can assist you in obtaining one.

I. Introduction

A. Definition of NABL

NABL, or the National Accreditation Board for Testing and Calibration Laboratories, is an organization that focuses on independent evaluation of the technical proficiency and standards of calibration and testing laboratories. It was established to provide India’s government, industry associations, and the industry itself with a reliable system of independent evaluation. NABL offers laboratory certification services to all testing and calibration labs, regardless of ownership, legal status, size, or level of independence, as long as they comply with ISO/IEC 17025:2005 and ISO 15189:2012 for medical laboratories. The NABL accreditation system caters to various scientific and engineering fields in the disciplines of biological, chemical, electrical, electronics, mechanical, non-destructive, photometry, radiology, thermal, fluid flow, and more. It also provides accreditation for companies that generate reference materials and proficiency testing services. Overall, NABL plays a vital role in increasing the credibility of accredited labs, granting access to web-based directories, and ensuring compliance with international standards for calibration and testing. [1][2]

B. Purpose of NABL accreditation

The primary purpose of NABL accreditation is to evaluate and ensure the technical competence of testing and calibration laboratories. The accreditation serves as a third-party assessment for the quality and technical competence of the laboratories. NABL accreditation adheres to the relevant international standards, which enables the laboratories to provide reliable and accurate results. Some of the key benefits of obtaining NABL accreditation are increased credibility, national and international recognition, and access to a web-based directory of accredited laboratories.

The accreditation process helps laboratories to conform to internationally recognized standards, which increases the quality of testing and calibration results. Additionally, NABL accreditation ensures consistency and repeatability of testing and calibration results across various laboratories in India.

NABL accreditation is mandatory for certain institutions such as medical laboratories, food testing laboratories, and others. The accreditation process involves evaluation, assessment, and decision-making phases, which are conducted by independent technical experts. Laboratories must comply with the prescribed standards and provide necessary documents during the application process. Continuous monitoring, surveillance, and improvement are required to maintain the accreditation.

In summary, the main purpose of NABL accreditation is to assess and ensure the technical competence of laboratories, to maintain consistency and repeatability in testing and calibration results, and to provide credibility to the laboratories. [3][4]

II. Eligibility for NABL Approval

A. Types of institutions requiring NABL approval

Any laboratory or testing institution in India must be certified by an accredited authority, and the National Accreditation Board for Testing and Calibration Laboratories (NABL) is the central authority for accreditation. While all labs must comply with relevant quality and assessment standards, specific types of institutions require NABL approval. These include medical laboratories, food testing labs, and other testing labs. In addition, any laboratory that conducts testing for regulatory compliance, such as environmental testing or drug testing, must be accredited by NABL. As part of the NABL approval process, labs must provide necessary documents to demonstrate compliance with the prescribed standards. Achieving NABL accreditation provides increased credibility for labs and grants recognition on both national and international levels. Access to a web-based directory of accredited laboratories further enhances the credibility of NABL-approved labs. [5][6]

B. Standards to comply with

To obtain NABL accreditation, laboratories in India must comply with various standards. The standards that NABL requires for accreditation are set out by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). The standard relevant to NABL accreditation is ISO/IEC 17025:2017. The standard outlines general requirements for the competence of testing and calibration laboratories. Laboratories must adhere to these standards in order to demonstrate their ability to provide accurate and reliable results in their testing and calibration activities. Additionally, laboratories must comply with specific technical requirements set out by NABL for their specific area of testing or calibration, such as mechanical, electrical and chemical, among others. Compliance with these standards ensures that laboratories provide accurate and reliable test results, which are essential to promoting public health and safety. [7][8]

C. Necessary documents for NABL approval

To obtain NABL approval, laboratories must provide the necessary documents to prove the compliance with accreditation standards. The required documents for NABL approval include a Quality Manual, which explains the laboratory’s quality policy, objectives, organizational structure, and procedures. The laboratory must also have standard operating procedures for each investigation conducted. The procedures should include the sample type, the method used, and the expected results. The laboratory must maintain accurate calibration records of all its instruments and equipment, which should be calibrated by NABL accredited laboratories. Additionally, the laboratory should document all aspects of documentation, such as document format, authorization, issue and withdrawal procedures, and document review and change. To assess the status of quality system and technical competence with regard to NABL, laboratories should also conduct internal audits and update management. Furthermore, it is essential for laboratories to participate in external quality assessment schemes and document corrective actions on IQC/EQA outliers. By submitting the necessary documents, laboratories can ensure compliance with NABL accreditation standards and obtain approval. [9][10]

III. Benefits of NABL Accreditation

A. National and international recognition

Having the NABL accreditation for your laboratory means more than just complying with Indian quality standards. It also brings national and international recognition to your services. Here’s how the accreditation can benefit your institution:

– National recognition: Becoming NABL accredited allows your laboratory to be recognized by government bodies as a reliable source of testing and calibration services. This can open doors to government-funded projects and collaborations with other institutions.

– International recognition: The NABL accreditation is internationally recognized through mutual recognition agreements with accreditation bodies from other countries. This gives your laboratory access to a wider market and increased credibility in the global market.

– Access to web-based directory of accredited laboratories: Once your laboratory receives the NABL accreditation, it is listed on the Quality Council of India’s web-based directory. This directory is widely referred to by organizations searching for reliable testing and calibration services.

Overall, the NABL accreditation gives your laboratory a competitive edge and increased credibility in the industry, both nationally and internationally. [11][12]

B. Increased credibility

NABL accreditation is not just a legal requirement, it can also result in increased credibility for institutions that go through the process. Here are some ways in which accreditation can boost credibility:

– Global recognition: NABL accreditation is internationally recognized, which means that institutions that are accredited have a competitive edge in the global market.
– Reliable testing and calibration: Accreditation assures customers that the services provided by an institution have been thoroughly assessed for competence, impartiality, and reliability.
– Consistency in operations: Accreditation requires institutions to adhere to standards for quality and competence in their operations. Institutions that earn NABL accreditation demonstrate that they have met these standards, which can inspire confidence in their customers.
– Access to a web-based directory of accredited laboratories: NABL maintains a web-based directory of accredited laboratories, which can help customers find reliable testing and calibration services more easily.

Overall, NABL accreditation can help institutions enhance their reputation and increase their credibility, both nationally and internationally. [13][14]

C. Access to web-based directory of accredited laboratories

Once a laboratory receives NABL accreditation, it is given access to a web-based directory of accredited laboratories. This directory serves as a valuable resource for customers looking for reliable and accredited laboratories to perform testing and calibration services. The directory can be accessed through the NABL website, and the list is regularly updated to ensure accuracy and relevance. Being listed in the directory provides increased visibility and exposure for the laboratory, leading to potential increases in business due to enhanced customer satisfaction and confidence. Customers searching for specific testing or calibration services can easily identify accredited laboratories that meet their needs and standards. This can lead to savings in terms of time and money since customers can avoid re-testing of products. Overall, access to the NABL directory is a significant benefit of obtaining NABL accreditation, as it provides laboratories with increased credibility, exposure, and potential business opportunities. [15][16]

IV. NABL Accreditation Process

A. Application process

The application process for NABL accreditation is a crucial step that a laboratory must undergo to obtain the certification. The laboratory is responsible for making an online application to NABL, including all significant details and paying a corresponding fee charged by NABL. After receiving the application form and the fee, the NABL secretariat will issue a unique identification number to the applicant and review the application for adequacy. If there are no inadequacies, the lead assessor will conduct an optional pre-assessment visit to the laboratory. During this visit, the lead assessor will check if there is a need for another assessment for security. Once the evaluation process is done, the lead assessor submits a well-defined report to the NABL Secretariat for future records. In case of non-conformities, the laboratory will take immediate actions to mitigate the risk factors within 30 days of report submission. After satisfactory actions by the laboratory, the NABL secretariat will re-assess the report and make a genuine appeal to the chairman of NABL. Once accreditation is granted, the NABL will issue various documents necessary for accreditation, such as NABL 100, NABL 112, NABL 126, NABL 151, and NABL 152. [17][18]

B. Evaluation and assessment

After a laboratory has submitted their application for NABL accreditation, the evaluation and assessment process begins. This process involves a thorough evaluation of the laboratory’s technical competence, quality management system, and proficiency testing performance. The laboratory must provide evidence of their compliance with the relevant standards and guidelines, including ISO/IEC 17025:2017.

During the evaluation and assessment process, NABL assessors will conduct an on-site assessment of the laboratory’s facilities, equipment, procedures, personnel, and management systems. They will also review the laboratory’s documentation and carry out proficiency testing to evaluate the accuracy and reliability of the laboratory’s test results. The laboratory is required to demonstrate their technical competence and compliance with the accreditation requirements.

Once the laboratory has successfully completed the evaluation and assessment process, NABL will make an accreditation decision. If the laboratory is accredited, they will be required to undergo regular surveillance assessments to ensure that they continue to maintain their technical competence and compliance with the accreditation requirements. Overall, the evaluation and assessment process is a crucial component of ensuring the reliability and accuracy of testing and calibration laboratories in India. [19][20]

C. Accreditation decision

After going through the evaluation and assessment process, the NABL decides whether to grant accreditation to the laboratory or not. The NABL accreditation decision is based on the compliance of the laboratory with the set standards and requirements. The labs that meet the standards of the NABL are awarded a certificate of accreditation. The accreditation decision made by NABL should not be taken lightly, and most importantly, it could impact the reputation of a laboratory. Once the laboratory is accredited, it is listed on the NABL website and can be accessed by all the interested parties. It allows the laboratory to demonstrate its credibility and assures its clients that it meets the set standards. This recognition adds to the laboratory’s prestige and gives it a competitive edge over other non-accredited labs. It also enables the laboratory to increase its business and expand its client base. The laboratory must maintain its accreditation by continually improving its services and meeting the NABL standards. [21][22]

V. Maintaining NABL Accreditation

A. Requirements for maintaining accreditation

Once a conformity assessment body (CAB) gets accredited by NABL, it is important to maintain the accreditation status. Accreditation maintenance is crucial to assure that the CAB’s technical competence is continued, and it can provide reliable services to its customers. The conformity assessment body must comply with the relevant standards consistently and continuously to maintain its accreditation status.

Some of the important requirements for maintaining accreditation are:

– CAB should fulfill the defined and documented procedures and maintain records and reports systematically.
– The CAB must ensure compliance with the relevant standards, laws, and regulations.
– CABs must aim for continual improvement of their technical competence. This includes improving the quality management system and providing training to its employees and upgrading its testing equipment.
– The conformity assessment body must undergo surveillance and monitoring audits by NABL periodically. The surveillances are to ensure CAB maintains its standard of technical competence is meeting the requirements stated in the relevant standards.
– CABs must report any significant changes in their system or services to NABL, which may affect the technical competence.
Maintaining accreditation status brings benefits such as increased customer confidence, increased access to market and increased international recognition. [23][24]

B. Monitoring and surveillance

Once a laboratory receives NABL accreditation, it is essential to maintain the standards put in place to ensure compliance. The NABL conducts regular inspections to ensure that accredited laboratories are continuously meeting the requirements. This monitoring and surveillance process is necessary to maintain the credibility of the accreditation.

The following points highlight the requirements for monitoring and surveillance:

1. Internal audits: Laboratories must conduct periodic internal audits to ensure that their quality system is functioning efficiently.

2. Quality control and proficiency testing: Laboratories must participate in quality control and proficiency testing programs to ensure their results are accurate and reliable.

3. Document control: Laboratories must maintain proper document control to ensure that the documented procedures and policies are current and up-to-date.

4. Complaints and corrective action: Laboratories must implement a system to handle any complaints received. They must also take corrective action to avoid similar problems occurring in the future.

5. Follow-up assessments: NABL conducts follow-up assessments to ensure that corrective actions have been taken, and the laboratory is compliant once again.

By maintaining accreditation, institutions can continue to operate with increased credibility and access to a web-based directory of accredited laboratories, offering numerous benefits to stakeholders. [25][26]

C. Continual improvement

Continual improvement is a vital component of maintaining NABL accreditation. The accreditation process is not a one-time task, but a continuous effort to enhance the quality of services provided by the laboratory. To achieve continual improvement, laboratories can take the following measures:

1. Encourage feedback: Feedback should be collected from the clients and employees to assess the laboratory’s strengths and weaknesses. The feedback should be used to make improvements where necessary.

2. Training and development: Laboratory staff should be continually trained and developed to keep up with changes in technology and techniques that would improve the quality of services.

3. Regular Quality Control checks: Regular Quality Control checks should be conducted to assess the laboratory’s performance in meeting the required standards.

4. Corrective Actions: Corrective actions should be taken whenever mistakes are made or non-conformities are detected during the accreditation process.

5. Benchmarking: Regular benchmarking should be carried out to compare the laboratory’s performance with industry standards and best practices.

By embracing the concept of continual improvement, laboratories can maintain their NABL accreditation, enhance the quality of services provided and increase credibility with clients [27][28]