NABL, an abbreviation for the National Accreditation Board for Testing and Calibration Laboratories, is an autonomous body established to accredit testing and calibration laboratories in India. It operates under the aegis of the Department of Science and Technology, Government of India. The primary objective of NABL is to assess the technical competence and reliability of laboratories conducting various tests and calibrations.
Laboratories seeking accreditation undergo a thorough evaluation process conducted by NABL assessors. This evaluation encompasses various aspects such as infrastructure, equipment, personnel competency, quality management systems, and proficiency testing. Accreditation by NABL signifies that a laboratory has demonstrated its competence in performing specific types of testing or calibration activities. It instils confidence in the reliability of the laboratory's services and enhances its credibility in the eyes of customers, regulators, and other stakeholders. Additionally, NABL accreditation facilitates acceptance of test results both nationally and internationally, thereby promoting trade and fostering trust in the quality of products and services.
Business loans can facilitate the process of obtaining NABL accreditation by providing financial support for the expenses involved in meeting the accreditation requirements. This may include investing in infrastructure upgrades, purchasing specialised equipment, hiring skilled personnel, and covering other associated costs. With the help of a business loan, laboratories and testing facilities can ensure they have the necessary resources to meet the stringent standards set by NABL, thereby enhancing their credibility and competitiveness in the market.
Eligibility criteria for NABL approval
To qualify for NABL accreditation, a Conformity Assessment Body (CAB) needs to meet the following eligibility requirements:
- The CAB must engage in activities such as laboratory testing, calibration, food processing, or R&D.
- A dedicated representative should be appointed to oversee the NABL accreditation process, possessing thorough knowledge of the CAB's existing quality procedures.
- The institution must maintain a documented quality manual aligned with standards like ISO/IEC 17025:2017, ISO 15189:2012, or ISO/IEC 17043:2010.
- A designated quality manager must undergo relevant training, including a minimum of four days of internal audit and management system training.
- The CAB must immediately implement its quality manual and meet the criteria listed in NABL 130, which sets standards for Site Testing and Site Calibration Laboratories.
- Mandatory participation in NABL's Proficiency Testing Program or, alternatively, inter-laboratory comparisons for quality assessment if no formal program is available.
- The CAB is required to complete at least one internal audit and a management review before submitting an application for NABL accreditation.
Steps for NABL approval
Here is the information without bold formatting:
1. Application for Accreditation
- Submitted by CAB to NABL.
2. Acknowledgement & Scrutiny of Application
- Performed by NABL.
3. Document Review
- Conducted by the Lead Assessor.
4. Pre-Assessment of CAB
- Performed by the Lead Assessor.
5. Final Assessment of CAB
- Conducted by the Assessment Team.
6. Scrutiny of Assessment Report
- Carried out by NABL.
7. Recommendation(s) for Accreditation
- Made by the Accreditation Committee.
8. Approval for Accreditation
- Granted by NABL.
9. Issue of Accreditation Certificate
- Issued by NABL.
Throughout the process:
- NABL provides information to the CAB.
- CAB undertakes necessary corrective actions based on root cause analysis, where required.
Validity of the NABL approval
After receiving the certificate, it remains valid for two years. NABL carries out annual surveillance as part of its procedure. To maintain ongoing certification, the CAB must submit a renewal application before the certificate expires, preferably six months in advance.
What is NABL objective?
NABL's primary objective is to provide accreditation to testing and calibration laboratories, ensuring they comply with international standards. By doing so, NABL aims to facilitate confidence in the results produced by these laboratories, promoting acceptance and recognition both nationally and globally.
Benefits of NABL accreditation
Advantages of NABL for healthcare professionals
- Enhanced expertise in calibration processes
- Potential for business growth driven by increased customer trust and satisfaction
- Recognition and broader market reach both domestically and internationally
- Reduced product retesting leads to savings in both time and costs
- Improved control over laboratory operations and more effective feedback
Advantages of NABL for individuals
- Confidence in receiving accurate reports from properly calibrated tests
- Trust in the expertise of the testing personnel
- Savings in time and money by avoiding unnecessary re-testing
- Satisfaction with the quality of services received
Principles of NABL accreditation
Here are the key principles of NABL accreditation:
- Reach out to the NABL secretariat to obtain the necessary documents related to the accreditation process.
- Familiarise yourself with all pertinent documents, the accreditation procedure, and the steps required for submitting an application.
- Nominate a staff member for training on quality management systems and internal audits by enrolling them in NABL's 4-day residential training programme.
- Develop a quality manual in compliance with ISO 15189 standards.
- Create a detailed standard operating procedure (SOP) for every laboratory investigation, ensuring proper environmental controls like temperature, humidity, and storage are maintained.
- Labs aiming for NABL accreditation must calibrate all instruments and equipment. Calibration must be performed exclusively by NABL-accredited calibration laboratories.
- Provide training to staff on documentation procedures, covering proper formatting, authorisation, issuance and withdrawal processes, as well as document review and change protocols. Each document should include an ID number, controlling authority's name, retention period, etc.
- It's important to remember that the quality manual serves as a policy document, which must be supported by additional procedural documents that also require proper preparation.
- Ensure that all processes outlined in the quality manual are thoroughly implemented.
- Document the internal quality control (IQC) measures used during patient testing, including uncertainties in measurements using tools such as Levy Jennings charts.
- Participate in External Quality Assessment Schemes (EQAS) and inter-laboratory comparisons for analytes not covered by available schemes.
- Record corrective actions taken in response to deviations in IQC/EQA results.
- Conduct internal audits and management reviews.
Submit your application for NABL accreditation and pay the necessary fees.
Process of NABL accreditation
The process of obtaining NABL accreditation involves several steps:
- Application submission
- Document review
- Pre-assessment visit
- Assessment
- Decision and accreditation
- Continuous surveillance
Each step ensures that the laboratory meets the required standards and maintains them consistently.
Importance of NABL accreditation
NABL accreditation is crucial for laboratories as it:
- Validates their competence and reliability
- Demonstrates compliance with international standards
- Enhances customer confidence and satisfaction
- Facilitates acceptance of test results globally
- Ensures quality and reliability in testing and calibration services
Guidelines for NABL accreditation process
Adhering to guidelines is essential for a smooth NABL accreditation process. Laboratories need to:
- Understand and implement relevant standards
- Maintain proper documentation and records
- Ensure competency of personnel
- Establish quality assurance procedures
- Participate in proficiency testing programs
- Commitment to these guidelines is key to achieving and maintaining accreditation
Conclusion
NABL accreditation is paramount for laboratories seeking credibility and acceptance in the industry. It not only assures quality but also opens doors to new opportunities. A secured business loan is one tool that you can take advantage of, if you're considering expansion or improvement for your laboratory.
