NSQF application file- J C 4 - IBSC - AMTZ - Vizag.pdf

Certificate in Biomedical Quality Assurance

  • Job DescriptionThe objective of the training program is to develop a pool of workforce which can be employed by focuses on the acquisition of skills necessary to develop quality control of medical devices and validation process. As per the training modules at the end of the training, the candidate would be certified to perform following activities - a) Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success. b) Prepares standard reports/ documentation to communicate results to the technical community. c) Responsible for developing appropriate test methods and inspection plans. Test methods shall be validated as necessary. d) Ensures quality products are developed in accordance to governing regulations and processes. e) Actively participate and assist teams with Risk Analysis to include Risk Assessments. f) Responsible for product change assessments, health hazard evaluations and product recall documentation.
  • Originally Approved23rd NSQC - August 2019
  • Last Revised-
  • Code2019/HLT/AMTZ/3578
  • SectorHealthcare
  • NSQF LevelLevel 6
  • Notional Hours500
  • Accrediting BodiesQuality Council of India (QCI)
  • Certifying BodiesIndian Bio Medical Skill Consortium (IBSC)
  • Proposed Occupation

    Quality Manager

  • Progression Pathway

    Professional Progression
    After the certification, the candidate will
    acquire specialized skills in the field of
    Quality Management.
    Initially the candidate enters the profession
    as Coordinator, with this professional
    certificate candidate gets promoted to
    higher levels as Quality Control Engineer,
    Quality Manager, Quality Assurance
    Manager and Quality Assurance Director.
    Academic Progression For diploma candidates they can entry
    directly to second year of engineering
    program in Bio-medical. Also, they can
    purse degree in distance mode. For
    engineering candidates, they can pursue
    M. Tech Biomedical or MBA in Hospital
    Administration. Also, they can pursue PG
    programme in distance mode.

  • Planned arrangements for RPL

    When the individual has relevant
    experience, he is assessed through a
    Recognition of Prior Learning (RPL)
    programme.
    The candidate is assessed through a
    combination of theory test, practical
    knowledge and verbal questioning or VIVA.
    The test is designed by SME or Subject
    Matter Expert who prepares the test
    material with total integrity and objectivity.
    The candidate is administered a written
    test of 45 minutes and a practical test of
    1.5 to 2 hours duration.
    Upon successful completion of the test the
    candidate is declared competent for yet to
    be competent, depending upon which the
    training is advised.
    The assessment is conducted by trained
    and qualified assessors appointed by
    IBSC. The tests are administered under
    strict confidentiality and absolute lack of
    bias or prejudice.

  • Qualification File NSQF application file- J C 4 - IBSC - AMTZ - Vizag.pdf
  • Supporting Documents
  • Formal structure of the qualification
    Title of unit or other component Estimated size (Hours) Level
    QM01 Medical Device Quality and Regulatory Fundamentals 125 6
    QM02 Risk Management & Risk Analysis 50 6
    QM03 Medical Technology Quality Systems 125 6
    QM04 Design Control & Product Development 100 6
    QM05 Design Verification, Validation, Clinical evaluation and CAPA 100 6
    Total 500 6
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