ISO 13485 Lead Auditor Certified Trainng | Certification Course | Updated 2025
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ISO 13485 Lead Auditor Certification Online Training

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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!
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Fee INR 18000

INR 14000

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  • Case Studies and Projects 8+

  • Hours of Training 45+

  • Placement Assurance 100%

  • Expert Support 24/7

  • Support & Access Lifetime

  • Certification Yes

  • Skill Level All

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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.
  • Classroom Batch Training
  • One To One Training
  • Online Training
  • Customized Training
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Upcoming Batches

05-May-2025
Mon-Fri

Weekdays Regular

08:00 AM & 10:00 AM Batches

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

07-May-2025
Mon-Fri

Weekdays Regular

08:00 AM & 10:00 AM Batches

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

10-May-2025
Sat,Sun

Weekend Regular

(10:00 AM - 01:30 PM)

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

11-May-2025
Sat,Sun

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

    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 .

    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
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    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.

    Get Certified

    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 FAQs

    Looking for better Discount Price?

    Call now: +91-7669 100 251 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
    • 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 project experience, job support, and lifetime resources.
    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 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
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