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राष्ट्रीय जैविक संस्थान

National Institute of Biologicals

स्वास्थ्य एवं परिवार कल्याण मंत्रालय,भारत सरकार
Ministry of Health & Family Welfare, Government of India
Azadi Ka Amrit Mahotsav
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**Mandatory documents for COVID-19 kits / VTM submission **        ** Sample Submission Guidelines **         ** KIND ATTENTION: NEW Testing fee document (R-106) with respect to rationalised sample Quantity (highlighted in Red) for submission for testing at NIB. Kindly check before submitting any batch ** **        ** Information about updated sample quantity to Port Offices and DCG (I) ** **

Quality Management Unit (QMU)

“QUALITY IS NEVER BY ACCIDENT: IT IS ALWAYS THE RESULT OF INTELLIGENT EFFORT”

John Ruskin

QUALITY MANAGEMENT SYSTEM OF NIB IS WOVEN INTO THE FABRIC OF ITS OPERATIONS AND ETHOS, ENSURING THAT IT DELIVERS THE LEVEL OF SERVICE IN RESPECT OF TESTING OF BIOLOGICAL PRODUCTS.


NIB was accredited in accordance with International Standard ISO/ IEC 17025- General Requirements for the competence of testing and calibration laboratories for the first time in the year 2011 in the disciplines of biological testing and chemical testing ; enabling laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work.

This accreditation serves as evidence that NIB not only maintains a high-quality system but also possesses technical competence, ensuring the generation of valid results. The certification encompasses various facets of laboratory management, including sample receipt, preparation, analytical testing competence, documentation control, facility and environmental conditions, equipment, traceability, and reporting.

Quality Management Unit (QMU), now an independent Unit since 2020, ensures the best global practices for quality evaluation of various biologicals being tested at NIB. Apart for coordinating External Accreditation Audits , Unit as well as coordinates between Labs, Procurement and Vendors to facilitate the smooth functioning and maintenance of Equipment (>400) as well.

QMU primarily performs following functions:

  1. Develops, implements, and maintains a comprehensive documentation system that includes procedures, instructions, and records related to testing and calibration activities.
  2. Ensures that all personnel have access to the latest versions of relevant documents and that documentation is systematically controlled.
  3. Conduct internal audits to assess compliance with ISO 17025 requirements and identify areas for improvement.
  4. Conduct regular management reviews of the QMS to ensure its ongoing suitability, adequacy, and effectiveness.
  5. Use management reviews to identify opportunities for improvement and allocate resources effectively.
  6. Regularly assess and document the competence of laboratory staff, addressing any gaps through training in coordination with Training unit and development initiatives.
  7. Has established a system for handling customer feedback and complaints, including the investigation and resolution of issues raised by clients.
  8. Use customer feedback to drive continuous improvement initiatives.

These key functions collectively contribute to the laboratory's ability to consistently deliver accurate and reliable test and calibration results, meeting the requirements of ISO 17025 and building trust with manufacturers and regulatory authorities.



QMU HAS REPRESENTED NIB IN THE COUNTRY’S FIRST-OF-ITS-KIND LABORATORY EXCELLENCE AWARD LAUNCHED BY QUALITY COUNCIL OF INDIA (QCI) IN SEP 2021. THE AWARD WAS TO RECOGNIZE LABORATORIES (TESTING, MEDICAL AND CALIBRATION) THAT HAVE ESTABLISHED OUTSTANDING ACHIEVEMENTS IN THE FIELD OF QUALITY SERVICES AND BENCH MARKED IN THEIR DOMAIN FOR THEIR BEST PRACTICES. AFTER QUALIFYING SEVERAL ROUNDS, NIB WON THE PRESTIGIOUS 1ST PROF. S.K. JOSHI LABORATORY EXCELLENCE GOLD AWARD IN THE FIELD OF TESTING ON 6TH OCT 2022 BY THE QUALITY COUNCIL OF INDIA (QCI).

About UMU