Certified Medical Laboratory System (ISO 15189:2022) Internal Auditor

Medical Devices Programmes


About IGMPI


The Institute of Good Manufacturing Practices India, registered under SR Act XXI of 1860, Government of India, recognised by Ministry of Commerce & Industry, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI) presents a unique, friendly and interactive platform to get rid of all your GMP compliance related issues. GMP- an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing and sustainability services - in itself is the most dynamic part which witnesses frequent changes in terms of new rules being added and old ones being renewed. Thus, keeping oneself updated with current GMPs is essential to remain aligned with evolving industry requirement and standards.

Our team comprises knowledgeable professionals from diverse sectors such as Pharma, Healthcare, Food & Nutraceutical industries, pooling together their expertise, know-how, and practical experiences to create this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better education and training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food & Nutrition and Healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which includes GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite training programmes along with the knowledge of worldwide affairs of the industry. In short, a round-the-clock service is provided for any information in these areas required by anybody from around the country and abroad. Based on high standards of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC, etc., areas have been approved by Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. IGMPI is duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018.

Accreditation and Awards

IGMPI is recognized by the Ministry of Commerce & Industry, Government of India and duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018 (License number: ERO/EOMSM/L-8000027) for offering education and training programmes, services and processes in the areas of Pharmaceutical, Food, Nutrition, Healthcare, Environment Health & Safety (EHS), Environmental Social & Governance (ESG) and Marketing Communications.

Ministry of Commerce & Industry
Bureau of Indian Standards

Institute of Good Manufacturing Practices India (IGMPI) is registered as a non-profit society with its own Memorandum of Association and bye-laws under The Societies Registration Act, 1860, Government of India. IGMPI is an accredited Vocational Institution of Ministry of Education, Government of India.

The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:

  1. Programme Content
  2. Programme Design
  3. Programme Material
  4. Instructors
  5. Class size & Attendance
  6. Facilities
  7. Evaluation of Students
  8. Written Examination
  9. Certificate

IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.

IGMPI has been conferred with the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023". QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.

IGMPI's Membership with IPA

IGMPI is a Lifetime Institutional member of Indian Pharmaceutical Association (IPA).

IPA

Bureau of Indian Standards (BIS)

Bureau of Indian Standards (BIS) came into existence through an act of Parliament in 1987. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. The Bureau is a Body consisting of 25 members representing both Central and State governments, Members of Parliament, industry, scientific and research institutions, consumer organizations and professional bodies; with Union Minister of Consumer Affairs, Food and Public Distribution as its President and with Minister of State for Consumer Affairs, Food and Public Distribution as its Vice-President.

Quality Council of India (QCI)

Quality Council of India is set up by the Government of India to establish and operate national accreditation structure and promote quality through National Quality Campaign. QCI is registered as a non-profit society with its own Memorandum of Association. QCI is governed by a Council of 38 members and Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government. The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI.

International Recognition

For providing its education and training services to overseas students, IGMPI is registered with the Directorate General of Foreign Trade, Government of India and our Export Import Code is AADCI7680Q.

IGMPI is an Institutional Member of the International Society for Quality in Health CarelSQua

Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.


Certified Medical Laboratory System (ISO 15189:2022) Internal Auditor


Laboratories are responsible for delivering an average of 300,000 tests every working day in support of the nation’s health services. From blood tests to biopsies covering diagnosis or the ability to monitor treatment progress, medical labs provide the vital test results that inform treatment decisions and health outcomes. ISO 15189 accreditation underpins confidence in the quality of medical laboratories through a process that verifies their integrity, impartiality and competence. The ISO 15189 standard is an international quality standard for medical and clinical laboratories. Since 2007 and until its latest version update in 2022, this standard sets the requirements for quality management, technical processes, and competence in medical laboratories. Therefore, the ISO15189:2022 standard promotes confidence and high quality in medical laboratories' analysis and results generation. Quality control and assurance in a laboratory are essential and strictly regulated in many industries, such as food and health. Quality in laboratories generally refers to the accuracy and reliability of analysis and results. In addition, laboratories that have international standards gain more credibility and international recognition.

This program will enable the participants to:

Grow as per Demand for Quality Assurance

  • Healthcare Sector: As medical laboratories play a crucial role in patient care and diagnostics, there is a high demand for professionals who can ensure compliance with rigorous standards.
  • Regulatory Requirements: Laboratories must adhere to ISO standards to maintain accreditation and regulatory compliance, Internaling to consistent demand for Internal Auditors.

Work in Diverse Employment Settings

  • Certification Bodies: Organizations that provide certification services for medical laboratories often require Lead Auditors to conduct assessments and audits.
  • Consulting Firms: Companies that specialize in ISO standards and laboratory quality management systems frequently hire Lead Auditors to advise and assist clients in achieving compliance.
  • In-House Quality Assurance: Large medical laboratories or hospital networks may employ Lead Auditors internally to manage ongoing compliance and quality assurance programs.

Work in Diverse Employment Settings

  • Certification Bodies: Organizations that provide certification services for medical laboratories often require Internal Auditors to conduct assessments and audits.
  • Consulting Firms: Companies that specialize in ISO standards and laboratory quality management systems frequently hire Internal Auditors to advise and assist clients in achieving compliance.
  • In-House Quality Assurance: Large medical laboratories or hospital networks may employ Internal Auditors internally to manage ongoing compliance and quality assurance programs.

Career Advancement Opportunities

  • Specialization: As you gain experience, you could specialize in specific types of audits or aspects of laboratory management, enhancing your expertise and marketability.
  • Management Roles: With experience, you might transition into higher management roles within quality assurance or compliance departments.
  • Training and Development: Opportunities to train other auditors or laboratory personnel can further enhance your career prospects.

Gaining Global Opportunities

  • International Scope: ISO 15189:2022 is an internationally recognized standard, so your skills are transferable across borders, opening up opportunities in different countries and regions.
  • Multinational Corporations: Global companies with medical laboratories or healthcare operations may have roles for Internal Auditors to oversee compliance in multiple locations.

Skill Development and Certification

  • Continued Learning: Staying updated with changes in ISO standards and industry best practices is crucial. Continued professional development and additional certifications can enhance your career prospects.
  • Soft Skills: Strong analytical skills, attention to detail, and the ability to communicate effectively with diverse teams are important for success in this role.

Networking and Professional Organizations

  • Industry Associations: Joining organizations such as the International Register of Certificated Auditors (IRCA) or relevant professional bodies can provide networking opportunities and resources for career growth.
  • Conferences and Workshops: Participating in industry conferences and workshops can help you stay informed about new trends and expand your professional network.

Certified Study Resources

Module 1: Introduction/Fundamentals of Medical Laboratory Technology

Module 2: Laboratory Medical Devices, In –vitro devices, Biologics

Module 3: Principles of Lab Management, Regulatory authorities & Medical Ethics

Module 4: Quality Testing Tools and Techniques, NABL accreditation

Module 5: Inspections and Audits Types (Internal and external Auditing), audit checklist

Module 6: Identification of documents and requirements of ISO 15189

Module 7: Nonconformity and Corrective Action

Eligibility

Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

The duration to complete this program is 3 days

Registration

The registration dates for this program run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the program lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • Assignments for all the programme modules for continuous evaluation and guidance.
  • Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
  • Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination
  • All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • All learning and training delivery initiatives shall be conducted in English.

Assessment & Certification

Online assessment will be conducted at the end of the programme and after successful completion; the participants will be awarded Certified Medical Laboratory System (ISO 15189 2022) Internal Auditor by IGMPI.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical healthcare like, LabCorp, Quest Diagnostics, Eurofins Scientific, Mayo Clinic Laboratories, SGS, Bureau Veritas, Quality Systems International (QSI), PJR (Perry Johnson Registrars), NSF International, Thermo Fisher Scientific, Beckman Coulter, Roche Diagnostics, Siemens Healthineers, LabWare, STARLIMS, LabVantage Solutions, Dr. Lal PathLabs, Metropolis Healthcare, SRL Diagnostics, Thyrocare Technologies, Pathcare Labs, Healthians, LabCorp India, CureMetrix, Apollo Hospitals, Fortis Healthcare, Max Healthcare, Medanta Health care, Oncquest Laboratories, Viva Diagnostics, Bharat Laboratories, NuLife Diagnostics, MyLab Discovery Solutions, Sundaram Medical Foundation, Jaypee Hospitals, Amrapali hospital, Akash health care, Eurofins Scientific, Subharti Medicare, Synlab, Sharda Hospital, Max Superspeciality hospital, Kailash Hospital and Medicare, Apollo Hospital, National Cancer Institute Laboratories, Johns Hopkins Medicine Laboratories, Cleveland Clinic Laboratories, Roche Diagnostics, MedLab, etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Medical Laboratory System on regular basis.

Future Prospects

The future career prospects for Certified Medical Laboratory System (ISO 15189: 2022) Internal Auditor are robust and diverse, driven by the industry's increasing reliance on quality data driven and technological advancements. As Hospitals, Laboratory and Research companies continue to embrace digital transformation with utmost quality, there is a growing demand for professionals skilled in Medical Laboratory System Internal Auditor. Careers in this field will focus on audit programs in Medical Laboratory System of high quality. Engaging in quality of laboratory system to stay updated on emerging trends, technologies, and best practices in laboratory quality and audit management can provide future prospects to the growing Professionals. Involvement in developing new auditing techniques, quality management systems, or innovative compliance solutions can contribute to industry advancements and offer career growth opportunities. Overall, careers in Certified Medical Laboratory System will continue to evolve, offering opportunities in innovative laboratory research, health care audits and hospitals in determining strategic quality, decision-making, and operational excellence within the global healthcare landscape according to the International Standard (ISO 15189: 2022). The role significantly impacts the quality of the medical laboratory and diagnostic systems, thereby contributing to better healthcare outcomes. This meaningful work can be a strong motivator and enhance job satisfaction.


Advisory Board and team


Our Advisory Board Members : https://igmpi.ac.in/advisoryboard.html


For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free), Phone: +91 11 26512850


Institute of Good Manufacturing Practices India (IGMPI)

C-6, Qutab Institutional Area, Near Old JNU Campus, New Delhi-110016
18001031071 (Toll Free), Phone: +91 11 26512850