ISO 13485 Understanding and Internal Quality Auditing

ISO 13485:2016 • IN-PERSON WORKSHOP • LIVE VIRTUAL WORKSHOP

ISO 13485 Understanding and Internal Quality Auditing

Designed for new and current internal auditors, this course will provide you with the necessary knowledge of ISO 13485 and the skills to evaluate the effectiveness of the quality management system at your organization. You will be guided through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions.

Enrollment Options

Choose from our available Open Enrollment dates or request a private training session below.

Length

3 Days

Prerequisites

None

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

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.

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

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