ISO 13485:2016 Appreciation + Internal Auditor

Medical Devices Monitor ImageISO 13485:2016 Appreciation + Internal Auditor
Three Days

Maximize your learning and your time when you take advantage of an additional day of insight through ISO 13485:2016 Appreciation and Interpretation part of this select course package.

This course package combines...

  • ISO 13485:2016 Appreciation and Interpretation (Day 1)
  • ISO 13485:2016 Internal Auditor (Day 2 & 3)
An Appreciation courses provides you with the foundational information to understand quality management systems and how process effectiveness directly links with business performance and in an Internal Audit course, you’ll learn how to audit processes for effectiveness and efficiency.

In this course package, you will learn …

DAY 1:
  • The scope and application of the ISO 13485:2016 standard
  • The differences between ISO 13485:2003 and EN ISO 13485:2012 and ISO 13485:2016
  • Essential definitions and terminology and key requirements
DAY 2 & 3:
  • An overview of the ISO 13485 requirements
  • The role management systems and internal audits play in helping business manage their risks
  • The roles and responsibilities of an Internal Auditor
  • How to plan your audits and how to develop effective checklists
  • How to carry out your effective audits using LRQA’s 6 Stage Approach
  • To gather objective evidence through observation, interviewing and sampling of documents
  • To evaluate audit findings and determine conformity, nonconformity and effectiveness
  • To prepare value adding reports and findings accurately
  • What corrective action is and who is responsible for taking action
  • How to follow up and verify the effectiveness of corrective action taken
  • How to address common internal audit weaknesses within the medical device industry

Your future development

  • ISO 13485:2016 Implementation
  • ISO 13485:2016 Lead Auditor
  • Tutored Audits (coached live audit at your company)
  • Refer to LRQA’s Business Improvement courses

Course length

  • Three days

Contact us to learn more about ISO 13485:2016 training

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