Why this course?

Description

ISO 13485:2016 Lead Auditor Training

Accredited & Recognised by Exemplar Global

Course Duration:  40+ hrs

Applicable Standard:  ISO 13485:2016 and ISO19011:2018

Course Objective:

This course aims to equip participants with the knowledge and skills required to perform first-party (internal), second-party (supplier), and third-party (certification) audits of Quality Management Systems (QMS) for Medical Devices based on ISO 13485:2016. Participants will gain an in-depth understanding of audit principles, methodologies, and best practices to ensure compliance with regulatory and customer requirements.

Prerequisites:

• Basic understanding of ISO 13485:2016 requirements (recommended but not mandatory).
• Familiarity with Quality Management System (QMS) concepts.
• Experience in medical device manufacturing, quality assurance, or regulatory affairs is beneficial.

Who Should Attend?

• Quality Assurance and Regulatory Professionals in the Medical Device Industry.
• Internal Auditors and Management Representatives.
• Consultants and Professionals involved in Medical Device Certification.
• Individuals aspiring to become ISO 13485:2016 Lead Auditors.
• Medical Device Manufacturers seeking compliance with ISO 13485 and regulatory requirements.

Course Benefits:

• Comprehensive Understanding: Learn the ISO 13485:2016 standard, its clauses, and regulatory requirements.
• Audit Expertise: Gain skills in planning, conducting, reporting, and following up on audits as per ISO 19011:2018.
• Compliance & Risk Management: Identify and mitigate risks related to medical device quality management.
• Career Advancement: Enhance your professional credibility as a Lead Auditor.
• Flexible Learning: Self-paced online access with interactive content, case studies, and assessments.
• Certification: Receive a certificate of completion to demonstrate competency in ISO 13485:2016 auditing.

Join Our Weekly Live Doubt-Clearing Sessions

We are committed to your learning success! To ensure clarity and help you achieve your goals, we conduct live doubt-clearing sessions every week.

Why Attend?

• Get personalized answers to your questions.
• Clarify doubts on complex concepts or assignments.
• Interact directly with our expert instructors.
• Strengthen your understanding and confidence.

Certification Exam Guidelines

Examination Format:

• The certification exam comprises multiple-choice and descriptive questions designed to assess the comprehension of the Body of Knowledge.
• The exam will be conducted online and is available only in English.

Course Validity & Exam Timeline:

• Learners must take the final exam within 12 months of purchasing the course.
• Course access will remain available throughout the designated access period as applicable.

Note: Attempting the exam after the one-year period will require an additional fee.

Certification:

• E-certificates will be issued upon successful completion of the exam.
• Certificates will be delivered within 7 working days after passing the exam.

Sample Certificate:

• For a preview of the certification, click here.

Policy on Cancellation and Refunds

• The course to which you have subscribed cannot be replaced with another course.
• It is not possible to cancel a course once it has been purchased.
• There are no refunds for fees.
• Courses are not transferrable.
• Course Extension is possible. (How to seek a course extension, details are listed below)

For Technical Support-

Contact us at +91-8094078781  or drop a mail at [email protected]

*Prices may change at any time without prior notice.

Benefits of Doing Courses from Quality HUB India™

• Expert instruction: Quality HUB India has a team of experienced trainers and consultants who have extensive knowledge and practical experience in their respective fields.
• Relevant and up-to-date content: Quality HUB India courses are designed to be practical and relevant, and they are updated regularly to reflect the latest best practices and industry standards.
• Industry recognition: Quality HUB India courses are recognized by various organizations and institutions in the industry, which can enhance your credibility and help you to stand out in the job market.
• Online Weekly Live Doubt Clearing Session: Interact with the faculty online every week and clarify your doubts arising during the learning for one full year from the date of purchasing the course.
• Networking opportunities: Quality HUB India courses provide opportunities for attendees to network with professionals from different industries and backgrounds, which can help you build valuable relationships and expand your knowledge.
• Flexible learning options: Quality HUB India offers both online and classroom-based courses, which provides flexibility for busy professionals and allows you to choose the learning option that best fits your schedule and preferences.
• Affordable pricing: Quality HUB India courses are priced affordably, making them accessible to individuals and organizations of all sizes and budgets.

Awards & Recognitions

• “Indian Achiever’s Award 2021-22” by Indian Achiever’s Forum
• ‘THE 2022 Global Education Award’ by Xel Research & Journey Magazine
• “Top 10 Manufacturing Consultant 2022” by Industry Outlook Magazine
• “THE BEST Learning Platform of 2022” by Business Connect Magazine

Accreditations & Certifications

• Exemplar Global – Registered Training Provider (RTP)
• The Council for Six Sigma Certification (CSSC) – USA
• International Quality Federation (IQF) – USA
• International Accreditation Organisation (IAO) – USA
• ISO 9001:2015 – Quality Management System
• ISO 14001:2015 – Environment Management System
• ISO 29990:2010 – Learning Services for Non-Formal Education & Training