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ISO 13485 Lead Auditor Certification Online Training

Rated #1 Recognized as the No.1 Institute for ISO 13485 Lead Auditor Certification Online Training.

Become more knowledgeable with the help of industry experts by enrolling in ACTE’s ISO 13485 Lead Auditor Training. This course trains you in auditing and ensuring ISO 13485 compliance.

Our ISO 13485 Lead Auditor Online Course covers auditing processes, optimizing quality management systems, and the design, implementation, and management of ISO 13485 settings. We offer academic support and placement assistance to help you secure top jobs in quality management,ISO certification.

Start mastering ISO 13485 Lead Auditor skills today!
With over 400+ hiring clients and 7,646+ trained professionals.
Benefit from unlimited interview opportunities with leading MNCs.
Gain hands-on experience in real-world ISO 13485 audit environments.
Enjoy an affordable, industry-recognized curriculum with 100% placement support.
Join our complete ISO 13485 Lead Auditor Certification Online Training at Pro C!

Job Assistance

1,200+ Enrolled

In collaboration with

65+ Hrs.

Duration

Online/Offline

Format

LMS

Life Time Access

10k+ Placed Students Download Curriculum Interview Questions

Quality Training With Affordable Fee

⭐ Fees Starts From

INR ~~38,000~~

INR 18,500

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Stimulate Your Career With Our ISO 13485 Lead Auditor Certification Online Training

ISO 13485 Lead Auditor Certification Classroom Training is an introduction to the Anypoint Platform.
When you complete the Anypoint Platform Development: ISO 13485 Lead Auditor course, ACTE will provide you a Course Completion Certificate.
ISO is a new version of our Anypoint Platform Training strives to provide high-quality instruction that includes a practical approach and good underlying knowledge of core ideas.
Real-world training and projects for Introduction to the Anypoint Platform Development: ISO are delivered throughout weekday and weekend courses Training is also available.
Developers who want to learn more about ISO than what is covered in the Anypoint Platform Development - Fundamentals (Mule 3) course or the self-study MuleSoft.U Development Fundamentals course will benefit from this training.
We give you a step-by-step guide to developing the Anypoint Platform: Curriculum for students in both Introduction to the Anypoint Platform Development: Online Training for ISO 13485 Lead Auditor.

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Upcoming Batches For Classroom and Online

Weekdays

08 - Dec - 2025

08:00 AM & 10:00 AM

Weekdays

10 - Dec - 2025

08:00 AM & 10:00 AM

Weekends

13 - Dec - 2025

(10:00 AM - 01:30 PM)

Weekends

14 - Dec - 2025

(09:00 AM - 02:00 PM)

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What’s included ?

📊 Free Aptitude and Technical Skills Training

Learn basic maths and logical thinking to solve problems easily.
Understand simple coding and technical concepts step by step.
Get ready for exams and interviews with regular practice.

🛠️ Hands-On Projects

Work on real-time projects to apply what you learn.
Build mini apps and tools daily to enhance your coding skills.
Gain practical experience just like in real jobs.

🧠 AI Powered Self Interview Practice Portal

Practice interview questions with instant AI feedback.
Improve your answers by speaking and reviewing them.
Build confidence with real-time mock interview sessions.

🎯 Interview Preparation For Freshers

Practice company-based interview questions.
Take online assessment tests to crack interviews
Practice confidently with real-world interview and project-based questions.

🧪 LMS Online Learning Platform

Explore expert trainer videos and documents to boost your learning.
Study anytime with on-demand videos and detailed documents.
Quickly find topics with organized learning materials.

Curriculum

Syllabus of ISO 13485 Lead Auditor Certification Online Training

Module 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485

Course objectives and structure
Standards and regulatory frameworks
Certification process
Fundamental principles of Medical Devices Quality Management Systems
Medical Devices Quality Management System (QMS)

Module 2: Audit principles, preparation and launching of an audit

Fundamental audit concepts and principles
Audit approach based on evidence and risk
Initiating the audit
Stage 1 audit
Preparing the stage 2 audit (on-site audit)
Stage 2 audit (Part 1)

Module 3: On-site audit activities

Stage 2 audit (Part 2)
Communication during the audit
Audit procedures
Creating audit test plans
Drafting audit findings and non-conformity reports

Module 4: Closing the audit

Documentation of the audit and its review
Closing the audit
Evaluating action plans by the auditor
Beyond the initial audit
Managing an internal audit programme
Competence and evaluation of auditors
Closing the training

Show Less

Course Objectives

What is the role of an ISO lead auditor?

This course will teach you how to organize and lead a QMS, as well as how to analyze and report audit findings, evaluate corrective measures, and conduct follow-up and routine audits.

How do I become a lead auditor for ISO 13485?

Passing the required IRCA examination and skills assessment at the end of this IRCA approved training course will demonstrate knowledge and basic skills to conduct and lead a management systems audit.

What steps do I need to take to become ISO 13485 certified?

The ISO 13485:2016 certification process is broken down into six parts.
The quality system is being planned. Meeting regulatory standards (section 5.4). Medical device firms in the United States must follow FDA 21 CFR 820 when designing their quality plans.
Putting design controls in place.
Documents, records, and training are all important.
Processes of management
The audit for certification.

What does it mean to be a lead auditor Online Certification?

The certified lead auditor title is a professional certification for audit team leaders who work for certifying bodies or conduct supplier audits for large companies. Certification as a lead auditor needs a tertiary education as well as two years of experience as an auditor or a lead auditor in training.

What is the ISO lead auditor Online Training all about?

The ISO 9001 Lead Auditor course gives you the skills you need to conduct a Quality Management System (QMS) audit using generally accepted audit concepts, processes, and methodologies.

Is ISO 13485 mandated by law?

While the ISO 13485 Medical Devices standard isn't legally binding, several governments around the world, including the United Kingdom, make compliance with the Medical Devices Directive a legal obligation for businesses (MDD).

What are the requirements for becoming an ISO auditor?

Although there are no formal requirements for becoming an auditor, certification bodies must demonstrate that their auditors are competent. This is a challenging endeavor, and certifying bodies have devised a number of approaches and records to accomplish it, with varying degrees of success.

Who has the authority to certify ISO 13485?

ISO 13485 is not a personal standard; no one may be certified to it. Instead, a corporation or organization becomes certified. After a 5-day training session, an individual can become an ISO 13485 Certified Lead Auditor. This enables them to conduct audits of other businesses.

What steps do I need to take to become an ISO external auditor?

You must first have completed internal auditor or lead auditor training. After that, you'll need to take our one-day Advancing Your Audit Skills course. Our qualified teachers will next thoroughly watch and evaluate your performance during a live audit during our one-day qualification review.

Is it possible for the auditor to earn a decent living?

With three to five years of internal auditing expertise, you can expect to earn between $67,000 and $127,750 per year, with an average of $85,000. Internal auditors with one to three years of experience can earn up to 108,250 at the 95th percentile, with a midpoint pay of $68,000.

What Skills Does an auditor Course require?

Auditors must have certain abilities.
Exceptional attention to detail.
A good mathematical aptitude.
Problem-solving abilities are exceptional.
A strong desire to learn more about the financial system.
Ability to work under pressure and meet deadlines.
Ability to operate independently and as part of a group.
Strong computer capabilities.

Overview of ISO 13485 Lead Auditor Certification Online Training

ISO 13485 Lead Auditor Course shows the vital standards and practices of powerful quality administration framework reviews as per ISO 13485:2016 and ISO 19011, "Rules for evaluating the board frameworks". Experienced educators guide understudies through the whole review process, from dealing with a review program to giving an account of review results. Members will acquire the information and abilities to design, lead, report, and follow up a QMS review that lays out the similarity and improves in general hierarchical execution.

Need customized curriculum?

Hands-on Real Time ISO 13485 Lead Auditor Projects

Project 1

QMS Project

QMS is a set of company procedures targeted towards exceeding. It fits a company's vision and aims.

Project 2

Internal Audit Project

It adds value to management and the board by discovering and fixing process before external audits.

Our Top Hiring Partner for Placements

ACTE offers placement opportunities as an add-on to every student / professional who completed our classroom or Online ISO 13485 Lead Auditor Certification Online Training. Some of our students are working in these companies listed below.

We have associations with huge Indian firms that can help understudies. Temporary positions with enormous overall firms will be presented by organizations like HCL, Wipro, Dell, Accenture, Google, CTS, TCS, IBM, and others.
We'll educate kids utilizing a unique understudy entry that will be assembled and shipped off them.
At the point when understudies have completed 75% of the ISO 13485 Lead Auditor Certification course educational plan, we will set up a talk with calls for themselves and set them up for eye-to-eye collaboration with possible MNCs.
ISO 13485 Lead Auditor Certification Instructors help understudies in continuing their examinations and handling current industry issues.
We have an exceptional Placement Patron Team that helps learners in tracking down work that accommodates their capabilities.
We will direct Sample tests and meetings to make up for these insufficiencies in petitioner capacities.

Get Certified By ISO 13485 Lead Auditor & Industry Recognized ACTE Certificate

Acte Certification is Accredited by all major Global Companies around the world. We provide after completion of the theoretical and practical sessions to fresher's as well as corporate trainees.

Our certification at Acte is accredited worldwide. It increases the value of your resume and you can attain leading job posts with the help of this certification in leading MNC's of the world. The certification is only provided after successful completion of our training and practical based projects.

Complete Your Course

a downloadable Certificate in PDF format, immediately available to you when you complete your Course

Get Certified

a physical version of your officially branded and security-marked Certificate.

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About Experienced ISO 13485 Lead Auditor Trainer

ACTE ISO 13485 Lead Auditor Instructors are business specialists who have created cardiovascular workout regimes to give understudies the most ideal education.
In the wake of perusing the Guide, Certification Trainers clarify the nuts and bolts of boss assessment.
Our active preparation will furnish you with industry-important abilities that will empower you to flourish in a quickly evolving field.
Our Training Instructors are notable specialists in their fields who work for huge worldwide organizations and have at least 8+ long stretches of involvement.
Coaches approach a few support assets since they regulate Training Zones, which they can utilize to meet explicit preparation targets.
E.I.D, Coromandel International Ltd, Amazon, Flipkart, Arihant Retail, Paypal India Pvt Ltd, zebronics, and ChargeBee Technologies Pvt Ltd are only a small bunch of the organizations where our scholastics have worked.
Coaches might use the specialist Referral Hiring procedure to assist people with getting a new line of work in different circumstances.

Authorized Partners

ACTE TRAINING INSTITUTE PVT LTD is the unique Authorised Oracle Partner, Authorised Microsoft Partner, Authorised Pearson Vue Exam Center, Authorised PSI Exam Center, Authorised Partner Of AWS .

Course Syllabus

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Class Room
Online

Career Support

Placement Assistance

Exclusive access to ACTE Job portal

Mock Interview Preparation

1 on 1 Career Mentoring Sessions

Career Oriented Sessions

Resume & LinkedIn Profile Building

We Offer High-Quality Training at The Lowest Prices.

Affordable, Quality Training for Freshers to Launch IT Careers & Land Top Placements.

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What Makes ACTE Training Different?

Feature

ACTE Technologies

Other Institutes

Affordable Fees

Competitive Pricing With Flexible Payment Options.

Higher Fees With Limited Payment Options.

Industry Experts

Well Experienced Trainer From a Relevant Field With Practical Training

Theoretical Class With Limited Practical

Updated Syllabus

Updated and Industry-relevant Course Curriculum With Hands-on Learning.

Outdated Curriculum With Limited Practical Training.

Hands-on projects

Real-world Projects With Live Case Studies and Collaboration With Companies.

Basic Projects With Limited Real-world Application.

Certification

Industry-recognized Certifications With Global Validity.

Basic Certifications With Limited Recognition.

Placement Support

Strong Placement Support With Tie-ups With Top Companies and Mock Interviews.

Basic Placement Support

Industry Partnerships

Strong Ties With Top Tech Companies for Internships and Placements

No Partnerships, Limited Opportunities

Batch Size

Small Batch Sizes for Personalized Attention.

Large Batch Sizes With Limited Individual Focus.

LMS Features

Lifetime Access Course video Materials in LMS, Online Interview Practice, upload resumes in Placement Portal.

No LMS Features or Perks.

Training Support

Dedicated Mentors, 24/7 Doubt Resolution, and Personalized Guidance.

Limited Mentor Support and No After-hours Assistance.

ISO 13485 Lead Auditor Course FAQs

Looking for better Discount Price?

Call now: +91-7669 100 251 and know the exciting offers available for you!

Does ACTE provide placement?

ACTE is the Legend in offering placement to the students. Please visit our Placed Students List on our website
We have strong relationship with over 700+ Top MNCs like SAP, Oracle, Amazon, HCL, Wipro, Dell, Accenture, Google, CTS, TCS, IBM etc.
More than 3500+ students placed in last year in India & Globally
ACTE conducts development sessions including mock interviews, presentation skills to prepare students to face a challenging interview situation with ease.
85% percent placement record
Our Placement Cell support you till you get placed in better MNC
Please Visit Your Student Portal | Here FREE Lifetime Online Student Portal help you to access the Job Openings, Study Materials, Videos, Recorded Section & Top MNC interview Questions

Is ACTE certification good?

ACTE

Certificate

Certification is Accredited by all major Global Companies
ACTE is the unique Authorized Oracle Partner, Authorized Microsoft Partner, Authorized Pearson Vue Exam Center, Authorized PSI Exam Center, Authorized Partner Of AWS

Work On Live Projects?

The entire ISO 13485 Lead Auditor training has been built around Real Time Implementation
You Get Hands-on Experience with Industry Projects, Hackathons & lab sessions which will help you to Build your Project Portfolio
GitHub repository and Showcase to Recruiters in Interviews & Get Placed

Who are the Trainers?

All the instructors at ACTE are practitioners from the Industry with minimum 9-12 yrs of relevant IT experience. They are subject matter experts and are trained by ACTE for providing an awesome learning experience.

What if I miss one (or) more class?

No worries. ACTE assure that no one misses single lectures topics. We will reschedule the classes as per your convenience within the stipulated course duration with all such possibilities. If required you can even attend that topic with any other batches.

What are the modes of training offered for this ISO 13485 Lead Auditor Course?

We offer this course in “Class Room, One to One Training, Fast Track, Customized Training & Online Training” mode. Through this way you won’t mess anything in your real-life schedule.

Why Should I Learn ISO 13485 Lead Auditor Course At ACTE?

ISO 13485 Lead Auditor Course in ACTE is designed & conducted by ISO 13485 Lead Auditor experts with 10+ years of experience in the ISO 13485 Lead Auditor domain
Only institution in India with the right blend of theory & practical sessions
In-depth Course coverage for 60+ Hours
More than 50,000+ students trust ACTE
Affordable fees keeping students and IT working professionals in mind
Course timings designed to suit working professionals and students
Interview tips and training
Resume building support
Real-time projects and case studies

Can I Access the Course Material in Online?

Yes We Provide Lifetime Access for Student’s Portal Study Materials, Videos & Top MNC Interview Question.

What certification will I receive after course completion?

You will receive ACTE globally recognized course completion certification Along with project experience, job support, and lifetime resources.

How Old Is ACTE?

We have been in the training field for close to a decade now. We set up our operations in the year 2009 by a group of IT veterans to offer world class IT training & we have trained over 50,000+ aspirants to well-employed IT professionals in various IT companies.

What Will Be The Size Of A ISO 13485 Lead Auditor Batch At ACTE?

We at ACTE believe in giving individual attention to students so that they will be in a position to clarify all the doubts that arise in complex and difficult topics. Therefore, we restrict the size of each ISO 13485 Lead Auditor batch to 5 or 6 members

Will I Be Given Sufficient Practical Training In ISO 13485 Lead Auditor ?

Our courseware is designed to give a hands-on approach to the students in ISO 13485 Lead Auditor . The course is made up of theoretical classes that teach the basics of each module followed by high-intensity practical sessions reflecting the current challenges and needs of the industry that will demand the students’ time and commitment.

How Do I Enroll For The ISO 13485 Lead Auditor Course At ACTE?

You can contact our support number at +91 76691 00251 / Directly can do by ACTE.in's E-commerce payment system Login or directly walk-in to one of the ACTE branches in India