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ISO 13485 Lead Auditor Certification Online Training

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  • Lead Auditor Infrastructure Preparation Techniques for Interviews.
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  • ISO 13485 Lead Auditor Certified Expert has been Offered for More than 12+ Years.
  • Next ISO 13485 Lead Auditor Batch to Begin this week – Enroll Your Name Now!

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Weekdays Regular

08:00 AM & 10:00 AM Batches

(Class 1Hr - 1:30Hrs) / Per Session


Weekdays Regular

08:00 AM & 10:00 AM Batches

(Class 1Hr - 1:30Hrs) / Per Session


Weekend Regular

(10:00 AM - 01:30 PM)

(Class 3hr - 3:30Hrs) / Per Session


Weekend Fasttrack

(09:00 AM - 02:00 PM)

(Class 4:30Hr - 5:00Hrs) / Per Session

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Job Oriented Tools Covered in ISO 13485 Lead Auditor Certification Online Training

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.
  • Classroom Batch Training
  • One To One Training
  • Online Training
  • Customized Training
  • Enroll Now

This is How ACTE Students Prepare for Better Jobs


Course Objectives

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.
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.
  • 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.
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.
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.
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).
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.
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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.

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Key Features

ACTE offers ISO 13485 Lead Auditor Training in more than 27+ branches with expert trainers. Here are the key features,

  • 40 Hours Course Duration
  • 100% Job Oriented Training
  • Industry Expert Faculties
  • Free Demo Class Available
  • Completed 500+ Batches
  • Certification Guidance

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 and National Institute of Education (nie) Singapore.



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
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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

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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.

ISO 13485 Lead Auditor Course Reviews

Our ACTE Reviews are listed here. Reviews of our students who completed their training with us and left their reviews in public portals and our primary website of ACTE & Video Reviews.



I underwent ISO 13485 Lead Auditor training in ACTE, Porur. The training session was good. My tutor Mr.Anbu have been outstanding. I liked the sessions taught by him who is an experienced faculty. Each and every topic is explained very clearly. Materials provided by him were useful. He is really good with his training and has the best content with him for the training which is really useful for a fresher like me to learn.

Dinesh Karthik


Good Institute for getting your basics right in any course, Thanks to Prabhu sir for training me for ISO 13485 Lead Auditor has around 10+ years of experience in ISO 13485 Lead Auditor and covers all the real time scenario's in the classes



I have enrolled for ISO 13485 Lead Auditor course in ACTE, Chennai It is a very nice experience. Trainer is very good and talented. All the concepts are thoroughly explained by the time you don't understand. Facilities are good. There is the provision of paying fees in instalment. Hence overall it's nice to choose



It was a great learning experience in ACTE, Banglore. The entire course structure designed for its students, the teaching methodology, as well as placement assistance, is really good. ACTE helped me a lot to get my first job. Had a wonderful opportunity to learn under the guidance of dedicated faculty team headed and gain knowledge in the field of ISO 13485 Lead Auditor . I would recommend ACTE to people who are interested to learn ISO 13485 Lead Auditor .



Very motivational environment. Best way to teach. Really appreciate the efforts they put from there side to increase the knowledge and development of students. Thanks, ACTE

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ISO 13485 Lead Auditor Course FAQs

Looking for better Discount Price?

Call now: +91 93833 99991 and know the exciting offers available for you!
  • 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
    ACTE Gives Certificate For Completing A Course
  • 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 and National Institute of Education (NIE) Singapore
  • 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
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.
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.
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
Yes We Provide Lifetime Access for Student’s Portal Study Materials, Videos & Top MNC Interview Question.
You will receive ACTE globally recognized course completion certification Along with National Institute of Education (NIE), Singapore.
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.
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
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.
You can contact our support number at +91 93800 99996 / Directly can do by's E-commerce payment system Login or directly walk-in to one of the ACTE branches in India
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