Course Details

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Learning Objectives

• Demonstrate an understanding of the purpose and intent of the ISO 13485 standard
• Compare the requirements between ISO 13485 and ISO 9001
• Recognize the role and responsibilities of management in ISO 13485
• Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide
• Recognize the relationship between ISO 13485 and ISO 14971
• Perform audits based on the ISO 19011 Standard
• Comply to the ISO 13485 Standard by applying the Process Approach to your quality management system
• Identify the principles of auditing and auditor responsibilities
• Plan an internal audit
• Conduct informal opening and closing meetings
• Conduct an audit based on process identification, sampling and questioning

Who Should Attend

Medical device quality professionals with knowledge of quality management systems and ISO 13485, individuals interested in conducting first-party or second-party audits, management representatives, internal auditors, managers, consultants.

Agenda

Day 1

• A brief review of ISO 13485
• Understand the relationship with ISO 14969
• Understand essentials of ISO 14971

Day 2

• Understanding (continued)
• Quality System Terminology
• What is an Audit? Types, objectives and relation to a standard
• Internal Auditors: attributes, roles and responsibilities
• Communication Skills: verbal, nonverbal and conflict situations

Day 3

• Plan For The Audit
• Prepare For The Audit
• Perform the Audit
• After The Audit