Apr 09, 2018 CERT.Global 3192times

Quality Management System Auditor / Lead Auditor Training Course (demonstrating compliance with ISO 13485:2016)

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry

ISO 13485 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.


The successful completion of Qualify Management System for Medical Devices (ISO 13485) Auditor / Lead Auditor Training Course, is pre-requisite and essential to become a QMS Auditor for Medical Devices industry.  

To participate this training course, the following prior knowledge were expected: 

  1. Knowledge of Management System Compliance (ISO 19600)
    • Process approach (Plan-Do-Check-Act)
    • Business overall compliance risk management (ISO 31000), includes legal, legislation, contractual obligations, standards, policies and procedures.
    • Top management leadership, other roles and responsibilities to support management system
    • Consideration of planning a management system - identify the organisational and technical measures to manage the identified risk
    • Supporting required by the management system 
    • Management system operation consideration - monitoring, reporting and communicating 
    • Performance evaluation of a management - objectives evaluation, Internal Audits and Management Review 
    • Continual improve the effectiveness of a management system
  2. Knowledge of quality management principles and concepts, includes but not limited to:
    • Strong customer focus
    • Management leadership
    • Engagement of people, includes internal and external
    • Process approach
    • Continual improvement
    • Evidence-based decision making
    • Relationship management
  3. Management system audit (ISO 19011)
    • Audit programme management 
    • Initial the audit
    • Prepare for an audit
    • Document review
    • Preparing for on-site audit
    • Audit skills
    • Conducting on-site audit 
    • Preparation of Audit evidences and findings
    • Audit report
    • Audit follow-up 
  4. ISO 13485 : Knowledge of the requirements of ISO 13485 and the commonly used medical devices management terms and definitions.
  5. Understand the management system certification requirements, i.e. ISO/IEC 17021-1 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements 
  6. Understand applicable legal, legislation and standards, includes but not limited to: 
    • IAF Mandatory Document MD9 using GHTF - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Devices Parts 1 to 5 and 
    • EU Directive 2013/473/EU or equivalent International equivalent documents
    • ISO 14971 (Application of risk management to medical devices life-cycle) 
    • IEC 62304 (Medical device software – Software life-cycle processes) 
    • IEC 62366-1 (Application usability engineering to medical devices)

Note. You are advised that course examination questions can relate to any requirement of ISO 13485 and the expected prior knowledge. For delegates who do not have these, we recommend attending our foundation training course. 

Who should attend?

This is intended for those who will be involved in leading audits of a QMS that conforms to latest ISO 13485 any organization.

Suggested job functions and their teams include:

  • People who involved in QMS for Medical Devices (ISO 13485) management process 
  • Medical devices developer, agent, supplier and service provider
  • Corporate governance managers
  • Risk and compliance managers
  • Management system representative, i.e. ISO 9001, ISO 13485
  • Consultant and management system professional
  • Legal and compliance 

Learning objectives

  • Learn how to explain the purpose and business benefits of a QMS for Medical Devices industry, of ISO 13485 standards, of management system audit and of third-party certification
  • Learn how to explain the role of an auditor to plan, conduct, report and follow-up a QMS for Medical Devices management audit in accordance with ISO 19011 (and ISO 17021) where appropriate
  • Learn how to plan, conduct, report and follow-up an audit of a QMS for Medical Devices industry to establish conformity (or otherwise) with ISO 13485 in accordance with ISO 19011 (and ISO 17021 where appropriate) or MDSAP (Medical Device Single Audit Program) requirements

Course benefits

  • Your organization will have an internal resource and process to be able to conduct its own audit of its QMS for Medical Devices industry to assess and improve conformance with ISO 13485
  • You will gain a professional qualification that certifies that you have the knowledge and skills to be able to lead a team to conduct an audit of a QMS for Medical Devices industry in any organization
  • Successful auditing will improve the protection of any QMS for Medical Devices management processes to meet market assurance and corporate governance needs
  • Understand how to identify gaps in a QMS for Medical Devices management system
  • Accurately audit will be able to provide continuous improvement to a management system
  • Meet training requirements for auditor certification 

Course outline

Day 1, management system knowledge (ISO 13485)

  • The benefits of QMS for Medical Devices industry
  • Process approach, Plan-Do-Check-Act (PDCA) and ISO 13485
  • Medical devices related terms and definitions 
  • Th eQMS for Medical Devices management processes and meaning for ISO 13485 auditor
  • Documented information for QMS for Medical Devices

Day 2, guidelines for auditing management systems (ISO 19011 and ISO 17021)

  • Purpose of audit
  • QMS for Medical Devices management internal audit, supplier audit and certification audit requirements
  • Audit processes
  • Auditor responsibilities 

Day 3, simulate the process of planning, preparation for an audit

  • Planning an audit
  • Preparation of audit work documents includes checklist
  • Conduct a Stage 1 audit (document review)
  • Prepare a Stage 2 (on-site) audit plan

Day 4, simulate the opening meeting, on-site audit activities, and role-play

  • Opening meeting 
  • Role play for audit scenarios 
  • Practice audit skills of collecting audit evidence
  • Prepare audit findings, includes conformance, non-conformity (NC), and opportunity for improvement (OFI) 
  • Prepare audit report 

Day 5, simulate the closing of on-site audit - close meeting and follow-up

  • Closing meeting 
  • Audit follow-up
  • Management system certification 
  • Course examination 

What's included?

  • Course material
  • Course examination 
  • Course certificate

Organizational information

  • Delegates should note that there are evening works during the course
  • The minimal numbers of delegates for this course is 4 and maximum is 20. If the students less than 4, the course will be postponed.
  • This course is facilitated by TKSG.Global online learning management system (LMS). The participants should have the capability to use their own PC, laptop notebook or suitable mobile devices to access the LMS.
  • This course is run in collaboration with CQI/IRCA Approved Training Partner - Hermes infotech Inc.

Additional Info

Venue (地點): Public or In-house training
Time (時間): 5 days
Facilitator (講師): Authorized tutor
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