ISO 13485 Lead Auditor Training

As per International Standards

  • Online/Group Sessions
  • 4 Days
  • Examination Included
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Highlight your proficiency in auditing with ISO 13485 Lead Auditor Certificate

ISO 13485 is an international standard that outlines the specifications for MDQMS. The standard assures the efficient development, design, manufacturing, and distribution of medical equipment. Organizations seek ISO 13485 Certification to show their conformity with regulatory requirements. To get certified, the business needs to submit to an audit by a recognized certification authority. An ISO 13485 Lead Auditor helps the company to prepare for the external audit. They assist them in meeting the requirements of standards. Further, they offer advice on how to meet the certification requirements. ISO 13485 Lead Auditor Certificate qualifies professionals to perform audits in an organization. It positions them up for success in the medical device industry. .

ISO 13485 Lead Auditor Certification Training

The medical device industry places a lot of emphasis on the ISO 13485 Lead Auditor Certificate. It displays individual proficiency in managing Medical Device Quality Management System and legal compliance. This certification boosts their marketability and opens doors to a variety of professional prospects. ISO 13485 Lead Auditor Training provides a thorough understanding of ISO 13485 standards. They learn best practices for establishing and maintaining a reliable MDQMS.

Key Features of ISO 13485 Lead Auditor Certification Training

ISO 13485 Lead Auditor Certification Training provides an understanding of the operations of an MDQMS based on ISO 13485. Individuals can opt for the live online method or the in-class method. During the training session, participants get familiar with industry-standard auditing procedures. Our trainers use examples from real-world situations to convey their viewpoints on MDQMS audits. They use their extensive expertise to make the subject matter interesting and engaging. After completing ISO 13485 course, professionals have to clear the exam and earn their ISO 13485 Auditor Certification. The certificate demonstrates one's auditing expertise. This enables them to pass the ISO 13485 Lead Auditor Interview.

  • 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
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ISO 13485 Lead Auditor Exam Format
Exam Name ISO 13485 Lead Auditor Certification
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

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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 Unichrone. 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

Which countries require ISO 13485 Certification?

Countries such as Europe, Canada, the USA, Japan, Australia, Singapore, and Malaysia require ISO 13485 Certification.

Why do organizations conduct ISO 13485 internal audits?

Organizations conduct regular ISO 13485 internal audits to evaluate compliance, identify improvement areas, and assess the efficiency of their QMS. The business must have a proper internal audit program and carefully record all of its policies, procedures, and internal audit reports.

What are the different versions of ISO 13485?

ISO 13485 was first published in 1996. It has two versions ISO 13485:2003 and ISO 13485:2016.

ISO 13485 Lead Auditor Examination Procedure

PREPARE

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

APPLY

Apply for the ISO 13485 Lead Auditor Exam, whilst filling up all necessary details. Attend the exam scheduled at the end of the training session.

ACQUIRE

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

1200+

Instructors

20+

Minimum Experience

100+

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.

ISO 13485 Lead Auditor Certified professionals can take job roles such as Quality Engineer, Quality Manager, Regulatory Affairs Specialist, Internal Auditor, Product Development Engineer, Quality Assurance Engineer, and Quality Assurance Director.

The cost of an ISO 13485 audit mostly relies on the company's workforce, the goods or services it provides, the complexity of its processes, the certification body, and the number of sites.

Organizations involved in the design, production, installation, and servicing of medical devices and related services need ISO 13485 Certification.

The resource management clause specifies the necessary resources (people, infrastructure, etc.) to guarantee that the QMS is efficient, continuously enhances, and designed to satisfy customers. The clause defines guidelines for documenting training records and requirements for competency documentation.

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

Companies begin by investing in the ISO 13485:2016 standard and doing a gap analysis to identify the areas where their present quality system complies and those where it doesn't. Organizations should put a strategy into action to achieve standard compliance after conducting a gap analysis. Establish a cross-functional team under the direction of a quality manager to begin the process of implementing the changes, and then figure out what needs to be done to align that process with the organization's quality system.

The QMS, or quality management system, helps device makers satisfy customer and regulatory obligations while also enhancing and sustaining the quality of their medical devices and related services.

ISO 13485 on-site audits are performed in full days. The duration of an audit relies on a variety of factors, including the organization's size, complexity, risk level, and type.

The purpose of stage one is to assess an organization's preparation for stage two of the Audit. It is frequently carried out remotely to reduce additional travel expense. If the ISO 13485 auditor finds that the organization satisfies the requirements for the stage one audit, the stage two audit will be conducted.

The external audits under ISO 13485:2016 standards include:
  • Customer audits
  • Supplier audits
  • Certification audits
  • Recertification audits
  • Surveillance audits

Delight

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.

Change

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.

View

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.

Entice

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.

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