Full program description

ISO 13485: 2016 Internal Auditor Training

What's In It For Me

  • To provide an overview to companies who wish to develop and implement an effective quality system based on the requirements of the medical device customer's requirements.
  • To equip participants with a detailed interpretation, element by element, on the ISO 13485:2016 standard requirements and auditing methodology.
  • To develop participants with in-depth knowledge and skills needed to audit, report and effective corrective action implementation of medical devices quality management systems.

Course Overview

This course has been specially designed to provide an overview to companies who wish to develop and implement an effective quality system based on the requirements of the medical device customer's requirements. This training will equip participants with a detailed interpretation, element by element, on the ISO 13485:2016 standard requirements and auditing methodology.

Who Should Attend

Personnel who involve in quality management, management system, project engineering and production planning & control are encouraged to attend.

Course Duration

14 Hours

Course Outline

  • Introduction to ISO 13485:2016 & ISO 14971
  • Interpretation of ISO 13485:2016 standard
  • Effective planning and auditing approach
  • System & Process based auditing
  • Document Verification against ISO 13485:2016 & ISO 14971
  • Effective reporting on findings
  • Effective implementation of corrective and preventive action
  • Case study & auditing exercise

Certification Obtained and Conferred by

Certificate of Competency

Course Objectives

This two days course is designed to develop participants with in-depth knowledge and skills needed to audit, report and effective corrective action implementation of medical devices quality management systems. Upon completion of this course, participants will able to plan and audit in accordance with ISO 13485:2016 including system and process approach. Participants will able to write non-conformance reports with reference to ISO 14971 (Risk management for medical devices).

Pre-requisites

Persons with some industrial, business and/or service sector experience.

Medium of Instruction & Trainer

1:20

Price

$642.00 (Inclusive of GST)
IS13IAT