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Course Details

ISO 13485:2003 Internal Auditor Course
  • Details
  • Entry Requirements
  • Schedules (Step 1)
  • Register (Step 2)
Course Duration
16 hours (2 days)
Course Fees
(inclusive of GST)
Main Office (Bendemeer)
72 Bendemeer Road #03-29 Luzerne Singapore 339941
More Information
Course Overview

This course aims to develop and implement quality management for medical device industry by using the knowledge of ISO 13485:2003. Using internal audit approach to fine-tune the medical device control system of organizations by providing knowledge and practical skills in the field for auditing Quality Management and Corresponding General Aspects for Medical Device Management System as per the requirements of ISO 13485:2003

Course Outline
  • Understand the requirements of ISO 13485: 2003
  • Understanding  quality control for medical device and continual improvement in organisations
  • Define the audit scope, criteria, frequency, methodologies, responsibilities and requirements
  • How to carry out documentation review, interviews and site inspection during an audit
  • Be able to plan, prepare and execute integrated management system internal audit effectively
  • Develop the skills of evaluating significance of audit findings and developing appropriate corrective/preventive measure
  • Preparation of audit report

Target Audience
  • Staff who are responsible for their company’s  ISO 13485 Management System
  • Personnel who are keen to learn to conduct ISO 13485:2003

No Entry Requirements.
Classes Schedules
DAY 1 - 2 : 09:00 AM - 06:00 PM
Attendee Category
Company Details
Individual Details

» Course registration shall be applied at least 3 days in advance. Registration is based on a first-come-first-served basis. To confirm the registration, payment of the course fees must be made before the commencement date. Avanta Global Pte Ltd (Avanta) reserves the right to decline a trainee from attending the class at its sole discretion.
» Certificate/card shall be issued within 1 month from the course completion date. For WDA courses, SOA shall be ready within 3 months from the assessment completion date as per WDA’s T&Cs.No certificate/card will be issued unless full payment is received by Avanta before the course ends. An email notification will be sent once the certificate/card is ready for collection. Uncollected certificate/card within 3 months from the date of email notification will be destroyed. An administrative charge apply to re-printing of replacement certificate/card at $20/-. (Police report is required for lost certificate/card case.)
» Trainee is reminded to attend class punctually. Full course fees will still be imposed if the trainee does not attend the class without prior notice.
» Notice of replacement or withdrawal must be made in writing to Avanta subjected to the following:
» No *administrative charge if notice of replacement reaches Avanta at least 3 working days before the course commencement date. Replacement of trainee is allowed only once.
» 90% refund of course fees if notice of withdrawal reaches Avanta at least 2 weeks before the course commencement date.
» 75% refund of course fees if notice of withdrawal reaches Avanta less than 2 weeks but more than 3 working days before the course commencement date.
» No refund of course fees if notice of withdrawal reaches Avanta 2 working days or less before the course commencement date.
All requests are subjected to the discretion and approval of Avanta.
» Reschedule or change of course is allowed once only and is subjected to the availability of the course. An *administrative charge is applicable if the request is made 2 working days or less before the course commencement date.
» Avanta reserves the rights to cancel the course or change the course dates. Refund of full course fees is applicable if the class is cancelled by Avanta.
*Administrative charge: 10% of the course fees or S$30/- (whichever is higher)
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