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

Certified Medical Laboratory System (ISO 15189:2022) Lead 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, leading to consistent demand for Lead 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.

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 Lead 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: General Hematology, histopathology and histotechniques

Module 4: Principles of Lab Management & Medical Ethics

Module 5: Regulatory Authorities and Quality Certification

Module 6: Quality Testing Tools and Techniques, NABL accreditation

Module 7: Understanding of auditing principles, audit checklist

Module 8: Inspections and Audits Types (Internal and external Auditing)

Module 9: Identification of documents and requirements of ISO 15189:2022

Module 10: 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 5 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) Lead 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 career prospects

The future career prospects for Certified Medical Laboratory System (ISO 15189: 2022) Lead 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 Lead 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.

View Prospectus

Programme Fee Details

How to apply

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