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PREMIUM COURSE

ISO 13485:2016 INTERNAL AUDITOR

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Course Objectives

  • Understand the requirements of ISO13485:2016 for medical products and related services
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
  • Acquire the skills to take on the position of an internal medical services auditor in the company

Target Audience

This training is designed for Quality and Regulatory Managers/Supervisors, Product Designers, Management Representatives, Internal Auditors and Consultants.

Methodology

Training input will consist of practical knowledge, role plays, case studies and self-revealing instruments and questionnaires. Learning will be enhanced through active involvement; individual and group exercises followed by review. Opportunities for self-assessment will be provided and feedback on individual and group performance will be encouraged. Participants will work on their own individual team issues during the program.

Course Modules

Module 1: Introduction to Quality Management System
Module 2: Overview of ISO 13485:2016 requirements
Module 3: Comparisons between ISO 13485:2016 and ISO 13485:2003 requirements
Module 4: Audit planning and preparation
Module 5: Audit execution
Module 6: Non-conformity reporting
Module 7: Closing meeting
Module 8: Audit report preparation
Module 9: Audit follow-up

Get To Know The Trainer

Trainer Anwar

 4.5

Mr Anwar is a Registered as Conformity Assessment Body for Medical Device Authority (MDA). He has been almost 20 years in Pharmaceutical industry. He completed his degree in Bac. Pharmaceutical from UNIVERSITI SAINS MALAYSIA In 1985 and Matriculation Program earlier in the same University.

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COURSE INCLUDES

  • 2 Days of training
  • E-Certificate of Completion
  • E-Training manual
  • Trainer logistic to client`s place

COURSE BENEFITS

  • 1 or 20 pax, same price
  • Confirmed-to-run even for 1 pax
  • Cheapest available (*we will price match!)
  • Money-Back-Guaranteed Quality
  • HRDF Certified & Claimable

ALL IN FROM ONLY

RM4,000/DAY

RRP RM5,715/DAY   SAVE RM1,715

*T&C Applies

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