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ONLINE TRAINING BY THE AUTHORITY

ISO 13485:2016

QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES

 

 Date:   10th -11th November 2021 (2 days)
Time:

 8.30 AM – 5.00 PM
Platform:

 Online Training

 

INTRODUCTION

This two-day online training course is to provide in-depth understanding on Quality Management System for medical device for those involved in the development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).

This training aims to help participants in understanding the scope and use of ISO 13485:2016 in complying with the Medical Device Regulations.

This training includes examination and participants who are successful in the examination will be given Certificate of Competency. For those who do not achieve the minimum passing mark, will be given certificate of attendance.

OBJECTIVES

  • To provide an overview and interpretation of the clauses of ISO 13485:2016
  • To understand the scope and use of ISO 13485:2016 in meeting the requirements of Medical Device Regulations
  • To highlight the importance of ISO 13485:2016
  • To improve the understanding in the requirements of ISO 13485:2016

 TARGET AUDIENCE

  • Medical device manufacturers;
  • Quality managers and regulatory affairs personnel
  • Other Medical Device Industry players
  • Conformity Assessment Bodies (CABs);
  • Internal and external auditors
  • Anyone involved with the implementation of the ISO 13485:2016 standard
  • Interested individuals

PROGRAMME OUTLINE

DAY 1

Date (Day)

10 November 2021 (Wednesday)

Time

9.00 AM – 5.00 PM

08.30 AM

Registration

08.50 AM

Briefing

09:00 AM

Overview of Quality Management System

Overview of ISO 13485

ISO 13485 Requirements

0. Introduction

1. Scope

10:30 AM

Break

10:45 AM

2. Normative References

3. Terms and Definitions
12.30 PM 

4. Quality Management System

1:00 PM

Lunch Break

02.30 PM

5. Management Responsibility

03.30 PM

6. Resource Management

04.30 PM

Q & A

05.00 PM

End of Training

 

DAY 2

 

Date (Day)

11 November 2021 (Thursday)

Time

9.00 AM – 5.00 PM

08.30 AM

Registration

08.50 AM 

Briefing

09:00 AM

7. Product Realization

10:30 AM

Break

10:45 AM

8. Measurement, analysis and improvement

Q&A session

1:00 PM

Lunch break

2.30 PM

Break out for examination

-       Briefing by MDA Officer

-       Revision by participants

3:15 PM

Examination

4:30 PM

Wrap up

5.00 PM

End of training

OUR TRAINER

PUAN FARIDAH BINTI SHAHIDIN

 

Madam Faridah binti Shahidin is currently a freelance assessor with Malaysian accreditation body (Department of Standard Malaysia). She has more than 25 years of experience in conformity assessment services; from her work experiences in manufacturing industries (medical device industries), auditing and certification of management systems activities.  

  • Lead Assessor for ISO/IEC 17021 (ISO 9001, ISO 14001, ISO 45001, Food Safety Management System ISO 22000, Good Manufacturing Practice (GMP based on MS 1514), HACCP (based on MS 1480), ISO 13485, MSPO, MSPO SCC S, ABMS ISO 37001, Malaysian Halal Certification based on MS 1500 etc.)
  • Lead Assessor for Personnel Certification accreditation programme based on ISO/IEC 17024
  • Lead Assessor for Product Certification based on ISO/IEC 17065.
  • Peer Evaluator appointed by Asia Pacific Accreditation Cooperation (APAC) representing Standards Malaysia for evaluation of accreditation bodies in under APAC (QMS ISO 9001, MDQMS ISO 13485 and Food Safety Management System ISO 22000)

REGISTRATION AND TRAINING FEE

  • The closing date for registration is on 3RD NOVEMBER 2021.
  • Training fee per participant: RM 1400.00
  • To register, please click HERE
  • Upon acceptance of the Registration, an invoice (for payment purpose) together with details of payment method will be issued accordingly
  • Registration of participants will be on a first-come-first-served basis.
  • Limited to 150 participants.
  • Upon payment confirmation, MDA will provide a link to join the training program.

CONTACT

For enquiries, please contact trainingpackage@mda.gov.my or 03-8230 0240 / 0355 / 0211

Updated: 12 October 2021