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-
- NSQF LevelLevel 6
- Notional Hours500
- Accrediting BodiesQuality Council of India (QCI)
- Certifying BodiesIndian Bio Medical Skill Consortium (IBSC)
- Proposed Occupation
- Progression Pathway
After the certification, the candidate will
acquire specialized skills in the field of
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)
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
- Annexure 2- Occupational Mapping Report
- Annexure 3- Functional Analysis Report - Allied Healthcare & Paramedics - 290413
- Annexure 4-RFP - HSSC NOS
- Annexure 5- Validation Group & Industry Consultations
- Annexure 6- QP-NOS- Certificate of Industry Engagement for building QPs
- Annexure 7- QA of Assessment in HSSC
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