close

Our Phone Number +353 (0)61 514 744

Our Email info@OptimaTraining.ie

ISO 13485:2016 Internal Auditor

Public Course

This ISO 13485:2016 Internal Auditor training course is a 2 Day public programme, designed to provide attendees with a knowledge and understanding of ISO 13485:2016 and its practical applications. The ISO 13485:2016 Internal Auditor will provide learners with an understanding of the process approach and how it relates to internal auditing.

Limerick
22/04/2024

If more than one separate with a comma

575.00

Make an Enquiry
Auditor,Word,Made,With,Building,Blocks

Course Content:

  • Introduction & Course Objectives
  • Introduction to ISO 13485
  • Eight Quality Management Principles
  • The Process Approach
  • ISO 13485 Quality Management System for Medical Devices
  • ISO 13485:2016
  • QMS / Internal Auditing
  • Principles of Auditing
  • Internal Audit Program
  • Audit Team & Auditor Competence
  • Audit Planning
  • Audit Evidence & Questioning Techniques
  • Audit Reporting & Follow Up
  • Q&A
  • Conclude & Follow Up Process

On the course completion participants will have the following;

  • An overall understanding of ISO 13485:2016, including the relevant elements and clauses
  • The knowledge of how to interpret these requirements
  • An understanding of the process approach and how it relates to internal auditing.
  • Knowledge of the theory and practice of internal auditing
  • Understanding of audit planning and assessing auditor competence

This ISO 13485:2016 Internal Auditor training programme may be beneficial to those responsible for audit program for ISO 13485:2016, for those who perform the audit, for Quality Assurance managers, ISO Project Managers, ISO Project Team Members and for Managers & Supervisors interested in deeper understanding of ISO 13485:2016 and its practical application.

Classroom based, instructor lead, practical hands on course.

Product Description

This ISO 13485:2016 Internal Auditor training course is a 2 Day public programme, designed to provide attendees with a knowledge and understanding of ISO 13485:2016 and its practical applications. The ISO 13485:2016 Internal Auditor will provide learners with an understanding of the process approach and how it relates to internal auditing.

Awarding Body: Optima Training & Consulting Ltd

National Framework of Qualifications Level: N/a

Certification: Optima Training & Consulting Ltd Certificate of Completion

Renewal: N/a

Entry Requirements:
Minimum age- 18 years old

Minimum English requirements: Leaners must be able to understand and convey the concepts contained in the programme content.

Assessment Details: Class Interaction

Cost Per Person:
The fee is inclusive of all training courseware materials, certificate of completion and 3 months after training support.

Progression Opportunities: Please see related courses

Protection for Enrolled Students: N/A

Should a course not proceed, any payment received will be refunded within 48 hours