ISO 13485 is a quality management system (QMS) standard for medical devices that's globally recognized and accepted. It's part of the ISO 9000 QMS series.
ISO 13485:2016 (MDQMS) aims to maintain and harmonize medical device regulatory requirements and QMS requirements.

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This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.
This course provides delegates with fundamental knowledge of assessment skills that will add value to organizations. It complies with PR 369 criteria. Successful completion of the course fulfils the formal training requirement for individuals seeking Third Party Assessments.
What I enjoyed was the Instructor's
command over the topic, authentic, subject specialist, expert - Active and lively delivery mode.
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Wonderful learning experience.
Certainly! I gained great insights
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Very experienced and provide many informative tips, good execution of the case studies and exercises..
Covered all the relevant topics and helped us to understand the practical side of things also. A very knowledgeable session
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I learned so much!
WILL LOVE TO ATTEND THIS SESSION ANYTIME AGAIN!
Elaborate course. Was explained with examples and the delivery was very good.
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Instructor is really great, on a scale of 5, I will give 5/5


Prem Kumar Sharma is a highly qualified professional with extensive certifications in various management systems. He holds multiple Lead Auditor certifications, including QMS, EMS, OHSAS, ISO 17021-1, MD-QMS, FSMS, LMS, and EnMS, with corresponding registration numbers and years of qualification. Sharma is also a member of prominent professional bodies such as the Quality Council of India, National Safety Council, Metrology Society of India, and Quality Circle Forum of India. He has a robust academic background with a B.Sc in Medical Sciences, an M.Sc in Organic Chemistry, and numerous certifications in steel making, quality management, industrial engineering, and safety management.
Sharma's career spans various roles in quality control, production, and management across diverse industries, including steel manufacturing, medical devices, and certification services. He has held key positions such as Vice President - QC & Developments, General Manager of Operations, and Regional Manager. His expertise includes chemical and instrumental testing, process control, heat treatment verification, and compliance with legal requirements. Sharma has also provided consultancy, training, and auditing services for QMS, EMS, OHSAS, FSMS, ABMS, and MD-QMS, conducting approximately 2500 man-days of third-party audits. His experience extends to delivering training courses on quality improvement, safety management, and anti-bribery management systems.

Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
Identify the purpose and benefits of an ISO 13485:2016 QMS
Explain the role of an auditor to plan, conduct, report and follow up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate).
ANYONE WHO ASPIRES TO BE :
A Third-Party Assessor or Lead Assessor of ISO 13485:2016
Responsible for undertaking audits of suppliers/subcontractors as per ISO 13485:2016
Medical device quality professionals interested in conducting first-party, secondparty, and/or third-party audits
Management representatives; Quality directors, managers, and engineers; Consultants
Responsible for implementing internal audits and audit programs as per ISO 13485:2016
Responsible for implementing the ISO 13485 series of standards
Identify the aims and benefits of an ISO 13485:2016 audit
Interpret ISO 13485:2016 requirements for audit application
Plan, conduct and follow-up auditing activities that add real value
Grasp the application of risk-based thinking, leadership and process management
Access the latest auditor techniques and identify appropriate use
Build stakeholder confidence by managing processes in line with the latest requirements
Exercising, doing a case study, and so on
Introduction
Terms
Principles
Framework
Process
Defining the
governance
Scope, context, & risk criteria
Risk identification
Analysis
Treatment
Evaluation
Recording & reporting
Monitoring & review
Communication & consultation
Certification Examination
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FQA, recognized globally as a leading knowledge organization, serves as a unifying platform for experts in Quality, IT, and Human Capital, dedicated to elevating the performance and market credibility of businesses and institutions worldwide.
The organization operates on the fundamental belief that an organization's path to improved quality is intricately intertwined with the continuous growth and development of its workforce. By prioritizing comprehensive skills development across all hierarchical levels, FQA enables leaders, management personnel, and teams to not only cultivate essential competencies but also foster a profound shift in attitudes and approaches towards quality commitments.
Through meticulously crafted workshops and programs, FQA strives to nurture a culture of strategic thinking and effective execution, empowering participants to internalize and apply the acquired skills to effectively drive their respective organizations towards the realization of their overarching vision, mission, and goals. Firm in its conviction that human potential, regardless of geographical location, can reach unprecedented pinnacles of excellence, FQA remains committed to equipping individuals with the necessary tools and motivation to create a more promising and impactful tomorrow.

Reach out to us today to explore how our tailored workshops can propel your organization forward.
Our workshops are meticulously crafted to align with your organization's unique needs and maturity levels.
Whether your preference is virtual engagement or an immersive face-to-face session on your premises, we've got you covered.
Our workshops can be seamlessly integrated into your operations, whether following a standardized format or custom-tailored to incorporate your team's specific suggestions and requirements.
