Last Updated on January 5, 2024 by The Health Master
Guidelines for Testing Laboratories
In a recent development, the National Accreditation Board for Testing and Calibration Laboratories (NABL) has released crucial Guidelines for Testing Laboratories, NABL 131, titled “Terms and Conditions for Obtaining and Maintaining NABL Accreditation.”
This contract outlines the requirements for accreditation and serves as a legally enforceable agreement between NABL and Conformity Assessment Bodies (CABs).
Failure to comply with these terms and conditions may result in adverse decisions, including legal action, as per NABL 216, ‘Procedures for Dealing with Adverse Decisions.’
Key Conditions for Conformity Assessment Bodies (CABs)
The newly released guidelines for Testing Laboratories emphasize the following conditions that Testing Laboratories, Calibration Laboratories, Medical Testing Laboratories, Proficiency Testing Providers (PTPs), and Reference Material Producers (RMPs) must adhere to:
1. Adherence to Relevant Standards
CABs must conduct their activities (Testing, Calibration, Medical, PTP, and RMP) in a manner that aligns with the requirements of the relevant standards (e.g., ISO/IEC 17025, ISO 15189, ISO/IEC 17043, ISO 17034, as applicable).
They should also comply with NABL’s specific criteria and application documents relevant to their accredited scope.
2. Updated NABL Documentation
CABs are required to maintain the latest versions of NABL documents and ensure their effective implementation.
Familiarity with relevant standards and NABL documents specific to their accreditation schemes is essential.
3. Legal Entity Status
One-person companies should possess a Registration Certificate under The Companies Act, 2013.
Limited Liability Partnerships must have a Registration Certificate under The Limited Liability Partnership Act, 2008, or a Company Registration Certificate under The Companies Act, 1956, or 2013.
Government entities should provide a gazette, a government notification, or a self-declaration on official letterhead signed by the Head of the organization.
Societies and trusts should present Registration Certificates under the Societies Registration Act, 1860, or registration certificates under The Indian Trusts Act, 1882.
4. Transparency and Disclosure
CABs must furnish all necessary information regarding their background, including history, establishment, ownership, and organizational structure.
Additionally, details on Key Personnel, Previous Experience, Legal Compliance, Disputes, Complaints, Quality Management systems, Financial Information (if required), conflicts of Interest, and accreditations or certifications from other bodies are required for NABL’s evaluation of accreditation eligibility.
5. Accurate Information Submission
CABs are required to provide accurate and complete information during the accreditation application process.
Any attempt to withhold relevant details or provide inaccurate information may lead to the rejection of the accreditation application.
6. Adherence to Regulatory Requirements
CABs must strictly adhere to National, Regional, State, and local regulatory requirements, Acts, Rules, Legal orders, Court Decisions, and Orders issued by Government or Statutory Bodies applicable at any given time.
7. Conflict of Interest Management
CABs are responsible for identifying and defining their various activities to ensure they do not lead to any potential conflicts of interest.
8. Qualified and Trained Personnel
CABs must have qualified and trained personnel for the applied and/or accredited scope, including sampling where applicable.
Test methods should follow current National or International standards, or as stipulated by regulatory bodies.
In cases where such methods do not exist, validated alternatives may be employed.
If CABs utilize in-house validated methods, validation data should be submitted along with the application.
Conclusion
Compliance with these outlined terms and conditions is imperative for Conformity Assessment Bodies seeking or possessing NABL accreditation.
Adhering to these guidelines for Testing Laboratories not only ensures accreditation status but also upholds the integrity and quality of testing and calibration practices in the country.
Failure to comply may result in adverse decisions, including legal repercussions, highlighting the significance of strict adherence to NABL 131.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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