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

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 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. 

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

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma and Professional Certifications Programmes. 10+2 pass-outs are eligible for our Under Graduate Diploma and Diploma holders of two to three years course duration are also eligible for the PG Diploma.

Programme Duration

The duration to complete this programme is 3 days

Programme Mode

Registration is currently open for Part-time (Online Live Classes) mode.

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.
• Part-time (Hybrid/Live 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 Medical Laboratory System (ISO 15189 2022) Internal Auditor by Centre for Health Management and Research, IGMPI.

Discipline in Classes and Examination

Every student is required to observe a disciplined behaviour during her/his classes, assessments & examinations and to follow instructions from the Professors. Any act of indiscipline may result into discredit & it will be mentioned in her/his academic report.

Placement Assistance & Corporate Relations

For the Post Graduate Diploma and Undergraduate Diploma Programmes, we will provide placement assistance after the completion of the programme. The Institute has partnered with many organizations for providing placement assistance to its students. The robust placement cell comprises senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.

In recent months the Institute has witnessed more and more participation from professionals working with global healthcare like , Jhpiego, SELCO Foundation, TATA Foundation, Samarthan NGO, PSI, UNICEF, WHO, HCL Foundation, IPE Global, Optum, PATH, AIIMS, Action against Hunger, Ekta Shakti Foundation, Seva Foundation, India HIV-AIDS Alliance, HLFPPT, Deepak Foundation, Novartis, LalPath Labs Ltd., Fortis Healthcare Ltd., HealthCare Global Enterprises Ltd., Indraprastha Medical Corporation Ltd., Narayana Hrudayalaya Ltd., Piramal Enterprises Ltd., Wockhardt Ltd., Cactus Communications, Public Health Foundations of India, Cytel, Religare Health Insurance Company Ltd., Deloitte, DuPont Sustainable Solutions, Bain & Company, Alvarez & Marsal, McKinsey & Company, 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 Pharmaceutical, Healthcare industries on regular basis.

Future career prospects

The future career prospects for Professional Certification 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 Professional Certification in 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.

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Apply Online

Last date for submitting completed Application Form: 6^th Aug 2026.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in