Introduction
ISO13485:2016 is an international standard that aims to ensure medical device manufacturer are meeting requirements of the customer and regulatory related requirements to ensure its perform as per its intended and safe to use. Compliance to this standard will ease the manufacturer to penetrate respective market by complying to its related regulatory requirements.
This new standard will replace ISO13485:2003 which its remain its structure with lot of new requirements being added in line with the development of regulatory requirements worldwide. Unlike the evolution of ISO9001:2015 with its Annex SL, ISO13485:2016 remain its 8 clauses with new and enhanced sub-clauses throughout the entire standards. This course will be emphasising in explaining the requirements.

Course Objectives

To provide delegates an understanding of the requirements

Course Outline:

  • Course introduction
  • Overview of structure & requirements of ISO 9001:2015
  • Introduction to auditing : definition, types of audits
  • Phases of audit : audit planning, audit preparation, audit performance & review, audit reporting & audit follow-up
  • Auditor attributes, competence & evaluation
  • Individual / Syndicate exercises, role play
  • Quiz / Games
  • Audit Checklist Preparation

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

Language: English

At the end of this course, participants will be able to:

  • Understand the background of ISO 9001 and be able to identify the requirements set by each standard.
  • Put into practice the fundamental techniques for performing internal audits. This means having the ability to identify improvement opportunities within your organization, and to prevent undesirable situations from occurring.

Training Methodology:

•PowerPoint - slideshow
•Activities / Workshop / Games

Agenda:

9:00 AM to 10:30 AM

  • Introduction of ISO13485:2016 and its development
  • Foundation of the standards, concepts, process approach

10:30 AM to 10:45 AM

Tea Break

10:45 AM to 12:30 PM

  • Terms and terminologies of the standard.
  • Clause 4 Quality Management System
  • General and documentation requirements (Medical Device Files)

12:30 PM to 1:30 PM

Lunch

1:30 PM to 3:00 PM

  • Clause 5 Management Responsibility
  • Management Commitment / Customer focus / quality policy /responsibility
  • Authority and communication / Management Review

3:00 PM to 3:15 PM

  • Tea Break

3:15 PM to 5:00 PM

  • Clause 6 Resource Managemen
  • Provision of resources / Human Resources / Infrastructure / Work environmental
  • Contamination control
  • Q & A
  • End of Day 1

DAY 2

9:00 AM to 10:30 AM

  • Clause 7 Product Realisation
  • Planning of product realisation / customer – related processes
  • Design and Development (Design Transfer & files) / Purchasing

10:30 AM to 10:45 AM

  • Morning Tea Break

10:45 AM to 12:30 PM

  • Production and service provision – cleanliness / Installation / Servicing / Sterile Implantable / Traceability / Calibration

12:30 PM to 3:00 PM

  • Clause 8 Measurement, analysis and improvement
  • Monitoring and measurement / Complaint Handling

3:00 PM to 3:15 PM

  • Afternoon Tea Break

3:15 PM to 5:00 PM

  • Reporting to regulatory / Internal Audit / Control of NCP – Action after delivery / Rework / Improvement / CA / PA
  • Q & A
  •  End of Day 2