Globally Accredited Certified Internal Quality Auditor ISO13485:2016 Online course

Certified Internal Auditor ISO13485:2016 (English)

Globally recognised and accredited Online Training and Certification course on Certified Internal Auditor - ISO13485:2016 (Medical Devices)

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Language: English

Instructors: Aryan Viswakarma

Validity Period: 365 days

$500 50% OFF


Why this course?


Course: Certified Internal Auditor for ISO 13485

Course Duration: 18 hrs

Applicable Standard: ISO 13485: 2016

Course Objectives

To provide students with the knowledge and skills required to perform an internal audit of part of a quality management system based on ISO 13485: 2016 and report on the effective implementation and maintenance of the management system in accordance with the standard.


It is recommended that all students have the following prior knowledge:

  1. Basic knowledge of the concepts of quality management and the relationship between quality management and customer satisfaction
  2. Understand quality management terms and definitions
  3. At least 1 year of industry experience

Who Should Attend?

This course is ideal for those who are responsible for internal management system audits including department managers, supervisors, quality representatives, engineers, and administrative staff who have a focus on business improvement, performance, and profitability.

Certification Exam

  • Each certification candidate is required to pass a written examination that consists of multiple choice and/or descriptive questions measuring comprehension of the Body of Knowledge.
  • The exam will be conducted online.
  • It is only offered in English.
  • Learners need to appear for the final test within 12 months of purchasing the course. Course access will remain till the access period as per the applicability.
  • *Taking an exam after one year will incur a fee*
  • After the certificate is issued, you must wait 30 days to get a hard copy of the certificate.
  • Learners can clear their doubts arising during the study within 06 months from the date of purchasing the course
  • For Sample Certificate Click Here

Pass Criteria:  > 60% marks

For candidates clearing the exam successfully certificate shall be issued by Quality HUB India, which is an ISO9001, ISO14001, ISO29990 Certified, IAO + CSSC + IQF Accredited and GOI registered organization for Consultancy, Training, Project Management, and Certification purposes.

  • Note: One extra opportunity will be given to unsuccessful candidates free of charge.

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  • Do not attempt to record the lectures in any other way. If you are caught unlawfully SELLING the lectures in full or in part, you will be forced to pay a large sum of money as compensation and face a slew of other legal consequences.

PS: Please contact us at +91-8094078781 or drop a mail at [email protected] /[email protected] if you notice any unlawful activity taking place in the name of Quality Hub India.

Format, Pdf, E-books, Templates availability:

All supporting format, Pdf, E-books, Templates as per the course requirement and within the scope, has been uploaded in the portal in the course section and downloadable.

No additional documents, formats, templates, etc shall be provided by QHI.

Policy on Cancellation and Refunds

  • The course to which you have subscribed cannot be replaced with another course.
  • It is not possible to cancel a course once it has been purchased.
  • There are no refunds for fees.
  • Courses are not transferrable.
  • Course Extension is possible. (How to seek a course extension, details are listed below)

For Technical Support-

Contact us at +91-8094078781 / 8824314500 or drop a mail at [email protected] or [email protected]

*Prices may change at any time without prior notice.


  • STEP 1 - Select the validity period for a course extension.
  • STEP 2 - Pay and Share screenshot on Mail: [email protected]


You can also pay by scanning a QR code. Kindly share a screenshot on mail at [email protected] with full details after payment (Name, Email id, Contact No. and Course Name)

Course Curriculum

    Introduction to ISO13485

  • Introduction to Medical Device Standard
  • ISO13485 – Benefits, Exclusion, and Non-Applicability
  • Introduction to Standard
  • Clarification of the Concept
  • Process and Process Approach
  • ISO13485 Compatibility with other management systems
  • ISO13485 Standard and Clauses

  • Introduction to ISO13485 Standard and Clauses
  • Scope (Clause 1) and Normative Reference (Clause 2)
  • Clause 3.0 Terms and Definition
  • Clause 4.0 Quality Management System
  • Clause 5.0 Management Responsibility
  • Clause 6.0 Resource Management
  • Clause 7.0 Product Realization
  • Clause 8.0 Measurement, Analysis, and Improvement
  • ISO19011:2018 – Guideline for Conducting Audit

  • Guideline for Conducting Audit
  • Clause 3 (Terms and Definitions)
  • Clause 4 (Principles of Auditing)
  • Clause 5 (Managing an Audit Program)
  • Internal Audit Schedule
  • Clause 6 Performing an Audit
  • Clause 6 Audit Check List
  • Clause 6 Performing an Audit
  • Clause 6 Interviewing Technique
  • Clause 6 Conducting the audit
  • Clause 6.4.2 – Third-Party Opening Meeting
  • Clause 6.4.7 – Collecting Information
  • Clause 6.4.8 (Generating Audit Findings)
  • Clause 6 (Audit Reporting
  • Clause 6 (NC Reports)
  • Clause 6 Closing of Audit
  • Clause 7 (Control of Audit)
  • Clause 7(Auditor Competency)
  • Non Conformity(NC) Report Writing
    • Content of NC Report
    • Non-Conformity Report Format
    • NC Report ISO13485 NC case Study
    • · Most Common NCRs observed during ISO13485 Audit

    Other Support Modules

  • Levels of Documents
  • Types of Processes: COP, MOP, and SOP
  • Quality Objective Tracker System
  • Important Audit Terms and Definitions
  • What is an Audit? Types of System Audits
  • Difference between `System’ and `Process’
  • Management Review Meeting (MRM)
  • Roles and Responsibilities of an MR
  • Practice Test Paper

    Supporting PDF, Formats, Standards, etc. provided for study and reference purpose

How to Use

After successful purchase, this item would be added to your courses.You can access your courses in the following ways :

  • From the computer, you can access your courses after successful login
  • For other devices, you can access your library using this web app through browser of your device.


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