ISO 13485 Internal Auditor

Training Course

Introduction

This two-day course will improve the effectiveness of the Quality Management System and help you understand the best practices to conduct an effective internal audit in accordance with the requirements of ISO 13485:2016.

Course Type

  • Classroom
  • In-house

Who should attend?

Individuals needing to conduct an effective QMS audit in accordance with the requirements of ISO 13485:2016 and ISO 91011:2011.

What will you learn?

  • An overview of the ISO 13485 requirements

  • The management systems and internal audits roles
  • The roles and responsibilities of an Internal Auditor
  • Plan your audits and how to develop the effective checklists

  • How to carry out effective audits using WECERT’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 report findings accurately, adding value to the business

  • What is corrective action and who is responsible for implementation

  • How to follow up and verify the effectiveness of corrective action taken
  • How to address common internal audit weaknesses within the medical device industry.

What do you need to prepare

Course Length

  • 3 days

What is included

  • Exemplar Global Approved Certificate

  • Training course materials
  • Lunch and refreshments for public attendees only

  • Certificate of attendance.

This WECERT‘s training course satisfies the formal training requirements stipulated by the Exemplar Global.

Exemplar Global certified training is mapped to a unique competency framework based on the latest skills needed by employers. As an Approved Training Partner, WECERT has been thoroughly assessed to ensure the highest standards.

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