Location

Productivity and Quality Institute - Alexandria

Objectives

• • Describe the ISO 13485 Medical Device Quality Management System (QMS) - Requirements for Regulatory Purposes standard and development process• Identify medical device QMS terms• Describe the intent and requirements of IAO 13485:2016• Determine the evidence needed to demonstrate conformity to ISO 13485:2016• Apply the process approach and Plan-Do-Check-Act (PDCA) methodology• Describe the relationship between ISDO 13485:2016 and applicable regulatory requirements• Apply the principles, processes, and methods of auditing• Demonstrate the activities involved in preparing for an audit• Determine an effective audit in the context of the auditee’s organizational situation• Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit

Outcomes

Learn how to design and develop medical devices to international quality standards such as ISO 13485, how to meet and keep ahead of medical device directive regulatory requirements, and gain knowledge of the CE Marking process.

Course Contents

• Scope and application of the new standard• The differences between ISO 13485:2003 and ISO 13485:2016• Essential definitions and terminology• Key requirements of ISO 13485:2016 and how they relate to each other to form a robust Effective system • The relationship between the standard and the risk management standard ISO 14971• An overview of the ISO 13485 requirements• The management systems and internal audits roles• The roles and responsibilities of an Internal Auditor• How to plan your audits and how to develop the effective checklists• How to gather objective evidence through observation, interviewing and sampling of documents• How to evaluate audit findings and determine conformity, nonconformity and effectiveness• How to report findings accurately, adding value to the business• What is corrective action and who is responsible for implementation• How to follow up and verify the effectiveness of corrective action taken•How to address common internal audit weaknesses with the medi