(Click Category to List Courses)

19 - ISO - ISO Management Systems (Standardization)


ISO 104 - ISO 13485 Management System for Medical Devices

Code Start Date Duration Venue Fees
ISO 104 07 September 2019 5 Days Istanbul $ 2950 Registration Form Link
ISO 104 05 October 2019 5 Days Istanbul $ 2950 Registration Form Link
ISO 104 02 November 2019 5 Days Istanbul $ 2950 Registration Form Link
ISO 104 28 December 2019 5 Days Istanbul $ 2950 Registration Form Link
DOWNLOAD PDF

 

Course Description

ISO 13485 is the most widely used for medical devices throughout the world; it shapes the quality management systems for medical device manufacturers globally; it applies to design, development, production, installation and servicing of medical devices.  This international standard drives customers and competitors to take quality seriously in medical devices design, research, development and manufacturing. ISO 13485 and compliance is a measure of the ability to meet customer and legal requirements.  This course is designed to provide participants with the knowledge to assist their companies in getting products to market more quickly.

Course Objectives

  • Understanding the importance of ISO 13485 on an international scale
  • Differentiating between ISO 13485 and ISO 9001
  • Getting grips with the different elements of ISO 13485 and ISO 14969
  • Being familiar with the relationship between ISO 13485 and ISO 14971
  • Define ISO 13485 management roles and responsibilities

Who Should Attend?

  • Supervisors
  • Quality managers
  • Executives
  • Internal and external auditors
  • Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
  • Anyone involved in the medical field

Course Details/Schedule

Day 1

  • Objectives of the initiative
  • The challenge for top management
  • Explain the structure and scope of the ISO 13485 management system standard
  • How ISO 13485 applies to the organization aiming for regulatory compliance worldwide
  • Compare the requirements between ISO 13485 and ISO 9001

Day 2

  • Describe the implementation process
  • Produce a project plan for implementation
  • Identify and justify the resources required for implementation
  • Eight quality management principles

Day 3

  • Overview of ISO 13485:2003 requirements
  • Overview of ISO 13485:2003 requirements – Clause 4
  • Overview of ISO 13485:2003 requirements – Clause 5
  • Overview of ISO 13485:2003 requirements – Clause 6
  • Overview of ISO 13485:2003 requirements – Clause 7
  • Overview of ISO 13485:2003 requirements – Clause 8

Day 4

  • Facilitate development of processes, policies, objectives, documentation and measurement techniques
  • Prepare for ISO 13485 certification
  • Interpret the clauses of ISO 13485 using ISO 14969:2005
  • Recognize the role and responsibilities of management in ISO 13485
  • Recognize the relationship between ISO 13485 and ISO 14971
  • Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide

Day 5

  • Introduction to ISO 13485:2003 audit trails
  • The relationship of risk classification of medical devices to QMS requirements
  • Risk classification rules
  • Risk classification names
  • Using accredited ISO 13485 certification in practice
  • Communication between stakeholders