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ISO 13485:2016 MDQMS Lead Auditor

Quality and safety is crucial when it comes to medical devices while regulations are becoming progressively demanding. The internationally recognised ISO 13485 Quality Management System for Medical Devices, was developed 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. Although not required by the standard itself, third-party audits and certification can demonstrate to regulators that you have met the requirements of the standard.


Gain the knowledge and skills to conduct third party audits of Quality Management Systems for Medical Devices with our Lead Auditor ISO 13485:2016 e-course.


Aims & Objectives
  • Outline the key requirements and benefits of ISO 13485:2016
  • Offer information on how to plan, conduct and follow-up auditing activities that add real value
  • Access the latest auditor techniques and identify appropriate use


Learning Outcomes

Having successfully completed this course you will be able to:

  • Learn the scope,importance and benefits of an ISO 13485:2016 QMS for Medical Devices
  • Demonstrate knowledge on the structure and key requirements of ISO 13485:2016
  • Gain the skills to effectively plan, conduct, report and follow up an audit in accordance with ISO 13485
  • Establish and plan the activities of an audit team, organise and direct audit team members
  • Communicate effectively with the auditee and audit client


Who should attend?

Professional working in the Medical Devices Manufacturing Industry as:

  • Management representatives
  • Compliance Managers
  • Quality Managers
  • Management System auditors
  • Consultants


Prerequisite skills & knowledge: None required


Available in-house/distant learning? Yes


Created by: LiberoAssurance Continuous Professional Development Training Centre Level 1 – Accredited by Greek Ministry of Education & Religious Affairs Accreditation No. 2101338


Part A Contents: ISO 13485:2016 Requirements

Annex ZA (informative)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 90/385/EEC (as amended)
Annex ZB (informative)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 93/42/EEC (as amended)
Annex ZC (informative)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 98/79/EC (as amended)
Clause 0-3
  • Introduction
  • Scope
  • Normative references
  • Terms and definitions
Quality management system
  • General requirements
  • Documentation requirements
    • General
    • Quality manual
    • Medical device file
    • Control of documents
    • Control of records
Management responsibility
  • Management commitment
  • Customer focus
  • Quality policy
  • Planning
    • Quality objectives
    • Quality management syste, planning
  • Responsibility, authority and communication
    • Responsibility and authority
    • Management representative
    • Internal communication
  • Management review
    • General
    • Review input
    • Review output
Resource management
  • Provision of resources
  • Human resources
  • Infrastructure
  • Work environment and contamination control
    • Work environment
    • Contamination control
Product realization
  • Planning of product realization
  • Customer-related processes
    • Determination of requirements related to product
    • Review of requirements related to product
    • Communication
  • Design and development
    • General
    • Design and development planning
    • Design and development inputs
    • Design and development outputs
    • Design and development review
    • Design and development verification
    • Design and development validation
    • Design and development transfer
    • Control of design and development changes
    • Design and development files
  • PurchasingProduction and service provision
    • Purchasing process
    • Purchasing information
    • Verification of purchased product
    • Control of production and service provision
    • Cleanliness of product
    • Installation activities
    • Servicing activities
    • Particular requirements for sterile medical devices
    • Validation of processes for production and service provision
    • Particular requirements for validation of processes for sterilization and sterile barrier systems
    • Identification
    • Traceability
    • Customer property
    • Preservation of product
  • Control of monitoring and measuring equipment
Measurement, analysis and improvement
  • General
  • Monitoring and measurement
    • Feedback
    • Complaint handling
    • Reporting to regulatory authorities
    • Internal audit
    • Monitoring and measurement of processes
    • Monitoring and measurement of product
  • Control of nonconforming productAnalysis of data
    • General
    • Actions in response to nonconforming product detected before delivery
    • Actions in response to nonconforming product detected after delivery
    • Rework
  • Analysis of data
  • Improvement
    • General
    • Corrective action
    • Preventive action
Annex A (informative)
Comparison of content between ISO 13485:2003 AND ISO 13485:2016
Annex B (informative)
Correspondence between ISO 13485:2016 and ISO 9001:2015

Part B Contents: ISO 13485:2016 Lead Auditor

The Audit
  • What is an audit?
  • Why Audit?
  • Audit Types
Audit steps
  • Performing Activities
  • Audit Plan
  • Developing Checklists
  • Opening Meeting
  • Conducting the Audit
  • Recording Results
  • Non-Conformities & Non-Compliances
  • Closing Meeting (s)
  • Audit Report
  • Audit Follow-up
Audit programme
  • Establishing the audit programme objectives
  • Identifying and evaluating audit programme risks and opportunities
  • Process flow for the management of an audit programme 
  • Managing an audit programme
  • Audit programme Implementation
  • Monitoring audit programme
  • Improving audit programme
Accreditation & Certification
  • Accreditation & Certification Bodies
  • Certification Process
Auditor’s Performance
  • Auditor’s Quality
  • The Auditors conduct
  • Auditor’s Code Conduct
  • Auditor Characteristics
  • Auditor's personal behavior
  • Auditee’s conduct
  • Selecting the audit team members
  • Skills of audit team leaders
  • How to evaluate an Auditor
  • Maintaining and improving auditor competence
Psychological factors during an audit
  • Attitudes and relationships
  • Obstacles and communication
  • Space and Time issues
  • Body language
  • Cultural factors
  • Principles of Listening
  • The Interview Step
Audit tips and techniques
  • Tips to trained auditor
  • Question Technique
  • Competence of the audit programme manager

Terms & Definitions

For ISO 13485:2016 standard

Exam & Certification

  • ISO 13485:2016 Lead auditor
  • "ISO 13485:2016 Lead Auditor" Certificate
Teaching Methods
  • Detailed seminar presentations (available for download)
  • Terms and definitions
  • No. of slides: 301


  • Reading lists & Resources: Available in the presentations


Study time allocation
  • Private study hours: 35
  • Trainer contact hours: Availability and competence of instructors upon request
  • Enrollment Duration: 90 days (starting from the date of purchase)
  • CPD Points: 35
  • ECTS/ECVET Points: 1.2

Assessment methods


% contribution to final mark

% Minimum passing grade

Exam for ISO 13485:2016 Quality Management System for Medical Devices Lead Auditor





On successful completion of the course assessment, participants will be issued with a ‘Certificate of Success’.



   100% Online course
   CPD Accredited eCertificate – Global acceptance
   Downloadable course material
  E-learning Mobile App
   Enrolment: 3 months
   Flexible schedule
   Language: English


View LiberoAssurance Certificate

195,00 €


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