ISO 13485 Lead Auditor Training

As per TUV-SUD Global Standards

  • Online/Group Sessions
  • 4 Days
  • Examination Included
Apply Now
Learn from Industry Experts

What is the scope of ISO 13485 Lead Auditor Certification

The ISO 13485 Lead Auditor Certification validates that an individual has acquired the skillset for conducting audits of the Medical Device Quality Management System (MDQMS). The latest version of ISO 13485 which is being followed by organizations currently, was released in 2016. The standard was introduced to emphasize on safety and performance of medical devices. ISO 13485 standard specifies the requirements that have to be followed by organizations manufacturing medical devices and related services. In addition, this international standard is considered as a legal requirement for such organizations across various countries. As a result, there is huge scope for professionals pursuing the certification of ISO 13485 Lead Auditor.

ISO 13485 Lead Auditor Certification Training

Medical device professionals, management representatives, quality managers, and individuals who want to master the skill of auditing MDQMS can pursue the ISO 13485 Lead Auditor Certification. Individuals can take up the ISO 13485 Lead Auditor Exam on completing the training session. The ISO 13485 Lead Auditor Training offered by Unichrone assists candidates to comprehensively understand the procedures and policies of the audit. Earning the ISO 13485 Lead Auditor Certification empowers professionals to prepare and carry out audits of MDQMS instilled within the organization.

Key Features of ISO 13485 Lead Auditor Certification Training

Individuals enrolling for ISO 13485 Lead Auditor Training program can choose to opt for live online method or in-class method. Participants are familiarised with industry-standard auditing techniques during the training program. In addition, our highly qualified trainers provide their insights on MDQMS audit through real-life examples. This in turn prepares aspiring lead auditors to clear the exam and earn their ISO 13485 Lead Auditor Certification.

  • 4 Day Interactive Instructor–led Online/ 5 day Classroom or Group Training
  • Course study materials designed by subject matter experts
  • Mock Tests to prepare in a best way
  • Highly qualified, expert & accredited trainers with vast experience
  • Enrich with Industry best practices and case studies and present trends
  • ISO 13485 Lead Auditor Course adhered with International Standards
  • End-to-end support via phone, mail, and chat
  • Convenient Weekday/Weekend Training Course schedule
Corporate Group Training
  • Customized Training
  • Live Instructor-led
  • Onsite / Online
  • Flexible Dates
Request for Corporate Group Training
ISO 13485 Lead Auditor Exam Format
Exam Name ISO 13485 Lead Auditor Certification
Exam Certification Body TUV-SUD
Exam Format Multiple Choice
Total Marks 100
Passing Score 70%
Exam Duration 120 Minutes

ISO 13485 Lead Auditor Course Curriculum

  • Topics

    • · Scope
    • · Focus
    • · Continual improvement
    • · Terminology
    • · Differences between the standards
    • · Similarities between ISO 13485 and ISO 9001

  • Topics

    • · Internal audit objectives
    • · Auditing skills
    • · Internal audit objectives
    • · Internal audit objectives
    • · Records and follow-ups
    • · Using correct procedures in reference to the 9001:2015 standard

  • Topics

    • · Definition of scope, objectives, and policies of a QMS
    • · Analysing implementation methodologies
    • · Methods to operate a QMS efficiently
    • · Planning, selecting and reviewing the implementation process
    • · Different ways to detect problems
    • · Roles and responsibilities of a Lead Implementer and quality team

  • Topics

    • · Report reconciliation and documentation
    • · How to maintain QMS structure through compliance policies
    • · Sequential operation process
    • · Measurement, monitoring and controlling of errors

  • Topics

    • · Roles and responsibilities of a lead auditor
    • · Lead Auditor requirements, scope, and procedures
    • · Report preparation, findings, reconciliation, and conclusions

  • Topics

    • · Team selection and planning
    • · Interactive meetings
    • · Opening meeting
    • · Daily discussion meetings
    • · Closing meeting
    • · Objective of an Audit Report
    • · Presentation of reports
    • · Techniques and processes of an audit

  • Topics

    • · Prevention of errors
    • · Rectifying errors efficiently
    • · Reviewing audit strategies and plans
    • · Follow ups
    • · Checklist closure
    • · Surveillance audit

  • Topics

    • · Visual observation
    • · Examination of records
    • · Employee interviews

ISO 13485 Lead Auditor Certification Benefits

Higher Salary

Earn 20% more salary than non-certified professionals in the field

Greater Responsibilities

Enhance your performance with additional responsibilities in the organization

Diverse Job Roles

Broaden your scope at the organization as compared to your peers

Global Recognition

Global recognition across different domains and industries with this certificate

Versatile Opportunities

Land at your dream job in large organizations with great expertise

Sophisticated Skillsets

Validates the advanced experience, skills and knowledge gained by professionals

Frequently Asked Questions

What skillset will I earn by enrolling in ISO 13485 Lead Auditor Training?

On attending the ISO 13485 Lead Auditor Training course professionals will be able to:

  • Obtain a comprehensive understanding of Quality Management System
  • Compare and correlate ISO 13485 Standard with the other standards
  • Interpret the different policies of ISO 13485
  • Assess the requirements of the ISO Standard

What is the duration of ISO 13485 Lead Auditor Training?

The ISO 13485 Lead Auditor Training is conducted for a duration of 4 days globally.

Why do I need ISO 13485 Lead Auditor Training offered by Unichrone?

Unichrone offers flexible modes of ISO 13485 Lead Auditor Training. Experts having vast experience in the field provide practical insights that help professionals to understand complex terminologies.

Do you provide a course completion certificate?

Yes, we provide a course completion certificate for professionals on completion of ISO 13485 Lead Auditor Training.

How is the ISO 13485 Lead Auditor Exam conducted?

The ISO 13485 Lead Auditor Exam is conducted in online mode by Unichrone. Candidates have to attempt multiple choice questions within 2 hours.

Can I retake the exam, if I fail in the first attempt?

Yes, candidates can retake the exam free for the second time. Subsequent attempts after 2nd attempt, the re-examination fees to be paid.

Who administers the ISO 13485 Lead Auditor Exam?

The ISO 13485 Lead Auditor exam is administered by the TUV-SUD Certification body. It is one of the globally recognized and accepted certifying body for ISO Courses.

What is ISO 13485 Lead Auditor Certification?

The ISO 13485 Lead Auditor Certification is awarded to individuals who can audit the quality management system of medical devices. The certification validates their sophisticated skillset in conducting audits of the Medical Device Quality Management System. As a result, businesses look for certified lead auditors to manage and implement the standard.

How will I benefit from ISO 13485 Lead Auditor Certification?

On acquiring the ISO 13485 Lead Auditor Certification professionals will be able to:

  • Acquire knowledge on the various requirements that are to be met for ISO 13485:2016 Standard,
  • Carry out smooth functioning of MDQMS,
  • Manage the position of MDQMS Auditor at ease.

What is the process of acquiring ISO 13485 Lead Auditor Certification?

In order to earn the certification of ISO 13485 Lead Auditor, professionals need to:

  • Enroll in ISO 13485 Lead Auditor Training course
  • Take up the Lead Auditor exam conducted by Unichrone
  • Pass the exam with the required score to attain the certification

What is the role of an ISO 13485 Lead Auditor?

A certified ISO 13485 Lead Auditor performs the role of:

  • Preparing for the audit of MDQMS
  • Conducts the audit of quality management system in accordance with the standard
  • Drafts report of the findings
  • Leads the audit team

ISO 13485 Lead Auditor Examination Procedure


Attend intense 4 day ISO 13485 Lead Auditor Training offered by Unichrone. Fulfil all the requirements specified by the TUV-SUD before the examination.


Apply for the ISO 13485 Lead Auditor Exam, conducted by TUV-SUD certification body, whilst filling up all necessary details. Attend the exam scheduled at the end of the training session.


On successfully passing the exam with required scores, earn the certificate of ISO 13485 Lead Auditor. You will receive an email confirming the status.

What our customers say

Kenneth Beard

Project Manager

Very engaging course with real world context and wonderful examples. Helped to expand my knowledge as a direct result of it.

Tom Eeartman

Head-Supplier Management

Super awesome faculty! The best part of the training was lots of real time case studies and interactive sessions. Learnt many new concepts.

Pavit Kenth

Technical Director MCI Ltd

Interesting, Focused, Real life case studies. The material was a comprehensive presentation of Lean principles and Six Sigma.

Saad Alsheddi

Head Of Operations

Really interesting, a lot of knowledge about processes, in many areas and departments, helped to understand the subjects easily.

Jernej Hercog

Manager-Engineering Services

I opted for Instructor led Online Session. The training was very well executed. It was awesome and exceeded my expectations.

Register for a free session with our trainer

Faculty and Mentors

Our certified and highly experienced trainers are handpicked from various industries to assist aspirants with practical insights into the field, thereby providing a comprehensive understanding of fundamentals and complex terminologies




Minimum Experience


Session Expertise

Yes, ISO 13485 Lead Auditor exam fee is included in training costs.

Professionals who have cleared ISO 13485 Lead Auditor Exam can pursue the ISO 13485 Lead Implementer Certification.

The ISO 13485 Lead Auditor Certification has lifetime validity. Certified professionals need not renew their credential every year.

Professionals need to obtain atleast 70% in the ISO 13485 Lead Auditor Exam to obtain the certification.

On completion of ISO 13485 Lead Auditor Training session, candidates can schedule their exam with Unichrone.


Grab the best prospect

ISO 13485 Lead Auditor Certification is a practitioner-level credential offered to individuals. Owning the Lead Auditor Certification enables professionals to choose the best prospect and enhance their career in the medical device industry.


Gain higher capabilities

The ISO 13485 Lead Auditor Certification offers up-to-date skills required to conduct audits of MDQMS. This entitles professionals taking up ISO 13485 Lead Auditor Certification to gain higher capabilities and master the auditing techniques.


Be identified

ISO 13485 Standard is recognized in various nations across the globe. Professionals taking up ISO 13485 Lead Auditor Certification can easily be identified among their non-certified counterparts. This further enables certified lead auditors to earn higher pay.


Lead the team

Professionals pursuing ISO 13485 Lead Auditor Certification are introduced to team management skills. As a result, certified ISO 13485 Lead Auditors can lead the MDQMS audit team and guide them in applying the latest auditing techniques necessary to comply with the standard.

Our Global Clients

Certified Associate in Project Management (CAPM) is the entry-level certification that can be pursued by individuals willing to start their career in project management. The Project Management Institute has set just basic requirements to be met by CAPM Certification aspirants. Prior to obtaining the CAPM certification, aspirants are required to have a secondary degree or global equivalent and 23 hours of project management education. Libero fuga facilis vel consectetur quos sapiente deleniti eveniet dolores tempore eos deserunt officia quis ab? Excepturi vero tempore minus beatae voluptatem!

Most in Demand PG Program in Data Science and Engineering Course

Gone are the days where a high five education was only accessible to a certain group of people. With the inception of the internet, anyone is able to access the data gathered from all corners of the world and gain knowledge. Data is a powerful tool of modern-day technology. The study related to this data has now become a buzzword which is Data Science.

What is Data Science?

In simple words, Data science can be defined as the scientific study of data to extract the needed information. Data Science also constitutes numerous methods of documentation, warehousing, and interpreting data to extract useful information productively. The ultimate aim of data science is to retrieve the sensible insights from the give data. There exists a huge amount of data on the internet on a daily basis, a lot of data is generated on the internet in the form of videos, content, photos, and many more. Accessing this data, through data science can result in deriving the most appropriate insights. All the algorithms in this technology teach about the application of various procedures and systems to extract meaningful insights and knowledge from the unstructured and structured data sets.

The Demand for Data Science

A career in data science now has become one of the most desirable jobs. In Post Millennium no corner of our lives left untouched by the application of technology, data science has been creating an insane impact. The demand for data science and data analytics is on the rise and it is expected to grow in the future. Data science has demonstrated its potential by invading many organizations regardless of the dynamics surrounding an organization. It has already become an integral part of many organizations. But, there is also a lack of data science employees in and around the country. With Organizations adapting data science, the requirement is growing exponentially while there is an obvious lack of talent. It has become a conundrum for many organizations across India.

Many youngsters that have perceived the importance of this technology and the revolution it has been creating in every industry it has been embraced by are now seeking a career in this field. As many job roles are being replaced by robots, it is important to look for a career that is promising. Companies such as Google, Cognizant, Oracle, and many are in dire need of data science professionals. The field of data science in India has around 97,000 vacancies which are really huge in number. This displays the ultimate demand that data science has all over the country. One of the studies by IBM has stated that the demand for data science would increase by 28% by 2020. So, make data science as your career choice as it assures a bright future.

The Impact of Data Science

Big data and Data Science are two elements that are reigning the modern era and it will rule relentlessly. Many companies are applying the techniques of data science to analyze and design their marketing plans and advertise their business in a better way. One better example that we could quote is the analysis of customer feedback using data science techniques and formulate the business meeting their requirements. Considering the huge amounts of data available, you can determine the best way to make a wise move to improve your market. A simple conclusion we could draw is that data science is a necessity for every growing industry.

Job Roles of Data Science

  • lorem lorem lorem lorem
  • lorem lorem lorem lorem4