NABL Accreditation Procedure: Step-by-Step Guide for Labs

NABL accreditation is an official recognition of a lab’s standards and reliability of their services. It is an assurance given to your lab’s clients and stakeholders about the safety and security of procedures. So, you must put in efforts to get your lab accredited and increase the scope of its operations. That’s where the NABL accreditation procedure becomes significant.

NABL accreditation procedure is a series of steps that lead to the declaration of the NABL symbol for labs. They can use it in official lab reports and promotional materials. However, it is not a permanent recognition. Labs have to maintain it and renew it every 2 years. Understanding the NABL accreditation process stands at the core of it all.

Types of Labs Requiring NABL Accreditation Procedure

• Testing laboratories
• Calibration laboratories
• Medical laboratories
• Medical imaging-conformity assessment bodies (mi-CABs)
• Proficiency testing providers
• Reference material producers

Terminology Used in NABL Accreditation Process

Accreditation: Accreditation is a 3P verification that a lab or testing body is competent to perform specific tasks. NABL provides this accreditation in India.

Accreditation Body: An organisation that grants accreditation. NABL is such an organisation in India, part of the Quality Council of India.

Scope of Accreditation: A formal statement detailing the specific activities for which a CAB is accredited.

CAB: A Conformity Assessment Body (CAB) is an organisation that is eligible for accreditation by NABL.

Accreditation Scheme: The set of rules and processes used by NABL for accrediting CABs, based on standards like ISO/IEC 17025 and ISO 15189.

Accreditation Body Logo and Symbol: While the accreditation logo is used by NABL to identify an accredited CAB, the accreditation symbol is used by labs to show their accredited status as per NABL guidelines.

Steps of NABL Accreditation Procedure

NABL accreditation is based on NABL accreditation principles and procedures established in accordance with international standards (ISO 17025). The complete procedure from start to finish is explained below in detailed steps.

Application for Accreditation

• Where to Apply: Use the NABL Web Portal www.nabl-india.org.
• Forms Needed:
  Testing Labs: NABL 151
  Calibration Labs: NABL 152
  Medical Testing Labs: NABL 153
  Proficiency Testing Providers: NABL 180
  Reference Material Producers: NABL 190
• Special Instructions for Medical Labs: Declare all sources of samples, including Sample Collection Centres (SCFs).
• Location Specific: NABL accreditation procedure requires separate application procedure each location, even for the same laboratory.
• Management System Compliance: Follow relevant standards (ISO/IEC 17025, ISO 15189, etc.).
• Complete Application: Include the Management System Document/Quality Manual, information, and application fee (refer to NABL 100A).
• Terms & Conditions: Read, understand, and accept NABL 131.
• Declaration Form: Submit a “Declaration Form” and update it within 15 days if changes occur.
• Site Testing or Mobile Facilities: Mention and specify the scope of accreditation for these facilities (refer to NABL 130).

Acknowledgement & Review

• Acknowledgement: A unique ID is provided after receiving the application.
• Initial Review: NABL reviews the application for completeness and may request additional information.
• Application Rejection: Possible if:
• Information is irrelevant or incomplete.
• Applied under the wrong category.
• Previous accreditation issues.
• False information or fraudulent behaviour.

Document Review

• Assessment Team: Reviews Management System Documents and submits a report.
• Conflict of Interest: CAB can raise objections about the assessment team.
• Inadequacies: CAB must address and correct any identified inadequacies within seven days.

Assessment

• Assessment Team: Includes various experts based on the scope of accreditation.
• Assessment Duration: Typically two days, may vary based on scope.
• Types of Assessments:

1. Pre-assessment: Optional but helps evaluate preparedness and determine resources needed.

2. Initial Assessment: Verifies implementation and compliance with standards, resulting in an assessment report.

3. Surveillance Assessment: Conducted annually to ensure ongoing compliance.

4. Reassessment: Done every two years before accreditation expiry.

5. Unannounced Assessment: Checks compliance and investigates complaints without prior notice.

Change Management

If there are any legal or other changes that may be relevant to NABL, they must be informed to NABL by following the rules below.

Name/Legal Entity Change: Inform NABL within 15 days, apply afresh, and follow instructions for new accreditation.

Ownership Changes: Inform NABL in advance, apply afresh after completion of changes, and follow instructions.

Premises Change: Apply afresh, provide documents, and await NABL’s decision. Assessment at the new location may be required.

Scope Changes:

• Extension: Apply with fees and undergo assessment.
• Reduction: Inform NABL if withdrawing part of the accredited scope.

Method/Equipment Changes: Inform NABL and submit evidence of competency.

Personnel Changes: Inform NABL and maintain records for verification during the next on-site assessment.

Decision Making about Accreditation

An independent committee of NABL will review and make decisions on issuing Accreditation. The final decision lies with the Sr. Director/Director of NABL who considers the committee’s recommendations, which come from a different group than the assessment team, who are qualified individuals. The committee receives comprehensive information to decide on granting, renewing, reducing, extending, suspending, or withdrawing accreditation.

Issues of Accreditation Certificate

NABL issues an accreditation certificate with a unique number and QR code, specifying the validity and scope of accreditation. The certificate is valid for 2 years, in line with APAC/ILAC MRA guidelines.

NABL Scope for Different Labs

Testing Laboratories: The NABL scope includes the types of tests performed, materials tested, and methods used.

Calibration Laboratories: The scope covers instruments calibrated, measurement ranges, and methods.

Medical Testing Laboratories: The scope includes tests performed, methods used, and details of associated sample collection centres.

Proficiency Testing Providers: The scope details the types of proficiency tests and characteristics measured.

Reference Material Producers: The NABL scope outlines the types of reference materials produced and the methods for characterising them.

Accreditation certificates are issued after all payments to NABL are cleared and include details for site and mobile facilities if applicable. The certificate is visible on the NABL portal and/or website once payments are complete.

Also check - List of NABL Accredited Labs

Maintaining NABL Accreditation

To maintain accreditation, CABs must always comply with relevant international standards and NABL policies, including the terms outlined in NABL 131. Any changes to these standards or criteria will be communicated to the CABs, who must then adjust within the given transition period. Failure to meet these requirements or to submit corrective actions on time may result in adverse actions such as denial, reduction, suspension, or withdrawal of accreditation.

Conclusion

Awareness of the NABL accreditation procedure ensures your lab meets high standards for quality and reliability. Adhering to these rigorous procedures not only demonstrates your commitment to excellence but also increases your lab’s credibility and operational scope, ultimately benefiting both clients and stakeholders. It is time for you to make a decision on that.