ISO 13485:2016 - Certified Lead Auditor

Certification Overview

ISO 13485:2016 - Certified Lead Auditor

Exam Code: ISO-QMS-13485

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

This Certification provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

Understand the requirements of ISO 13485:2016 to be able to conduct a successful audit. Learn how it compares to 21 CFR 820 and ISO 9001:2015. Conduct practical audit exercises to apply these requirements and manage the audit process in a collaborative and engaging environment. 

Exam Information

The exam comprises of 40 Multiple Choice Questions out of which the candidate needs to score 70% (28 out of 40 correct) to pass the exam.

Exams are online and proctored based, using a webcam and a reliable internet connection exams can be taken anywhere and anytime.

The total duration of the exam is 1 hour (60 Minutes).

No external sources of information may be accessed during the exam held via ProctorU. Further details of the materials permitted are provided:

  • Identification Proof.
  • If a Candidate does not pass the exam in the second (2nd) attempt, the candidate must wait for a period of at least fourteen (14) calendar days from the date of their attempt to retake the exam for third (3rd) time or any subsequent time.
  • The exam can be taken any number of times.

The ISO 13485:2016 - Certified Lead Auditor Certificate is valid for life.

Displaying your certificate

  • Remember, when labeling a product or system as certified to an ISO standard:
  • Don't say: "ISO certified" or "ISO certification"
  • DO say: "ISO 9001:2008 certified" or "ISO 9001:2008 certification" (for example).



Some prior knowledge of ISO 13485:2016 is recommended.

Course Outline

Module 1 - Foundation to ISO 13485

  • ISO 13485
  • Quality Management
  • Enhancing Organizations Image
  • Achieve Customer Satisfaction
  • Fully Integrated Processes
  • Decision Making
  • Continual Improvement
  • Workforce Engagement
  • Awareness
  • Stakeholder Definitions
  • Authorized Representative
  • Medical Device Family
  • Risk Management
  • Sterile Barrier System
  • Sterile Medical Device
  • Popular Standards

Module 2 - QMS

  • Operations of Quality Management
  • Roles
  • Support Processes
  • Manage Changes and Control
  • Validate Software
  • Document Procedure
  • Records of Software Validation
  • Create Manual
  • Develop Medical Device Files
  • Control Documents
  • Maintain Records
  • Planning Requirements
  • Managerial Requirements
  • Infrastructure Requirements
  • Environmental Requirements
  • Work Environment
  • Controls for Contractors
  • Combination Controls
  • Product Realization
  • Planning Requirements
  • Customer Related Processes
  • Servicing activities
  • Traceability
  • Process Validation¬†
  • Product Realization

Module 3 - Measurement, Analysis and Improvement

  • Monitoring and Measurement
  • Feedback
  • Complaint Handling
  • Reporting to regulatory authority
  • Internal Audit
  • Complaint Handling
  • Reporting to Regulatory Authorities
  • Complaint Evaluation and Investigation
  • Complaint Handling Procedures
  • Correction and Corrective Actions
  • Advisory Notices
  • Correction, Corrective Action
  • Analysis of Data

Target Audience

Management Representatives, ISO 13485:2016 Implementation Teams, Auditors and others who would like to learn the widely-used international management systems auditing process. Anyone who wishes to conduct, and potentially lead, medical device quality audits.

Registration Process for E-Course and Exam

Premium Package
(E-Course Version)

  • Self Explanatory
  • Valid for 40 days
  • The Package also includes E-Voucher/Access Key for Certification Exam
  • The E-Voucher/Access Key can be used via ProctorU Globally.
  • Hard Copy Certificate will be shipped to your mailing address within six to eight working weeks and a Digital Badge will be sent to your email if you qualify in the exam.
  • Course Duration: 38 Days
  • Price: 190 USD

Exam Registration

  • To Register for an Exam
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