Course Overview:

This highly participative 3-day course provides comprehensive instruction on auditing quality management systems based on the ISO 13485:2016 requirements. The training will provide an understanding of the ISO 13485:2016 requirements to be able to conduct a process-based audit.   The course includes a practical workshop based on actual auditing situations to enhance auditor’s skills and techniques. Reference is made to the regulatory requirements for medical devices on quality management systems. 

Student Prerequisites: 

Each student shall be required to have studied the current published version of ISO 13485:2016 prior to attending the course.  Please bring a copy of the standard with you to the course.

Key Session Topics:

• Describe ISO 13845 Quality Management Standards Requirements and related standards.
• Understand how internal audits perpetuate continual improvement within the company.
• Understand audit and medical device terminology.
• Learn how to construct an audit program and prepare for internal audits to maximize benefits of the activity.
• Apply process approach and Plan-Do-Check-Act (PDCA) methodology.
• Demonstrate effective audit techniques and personal behaviors necessary to conduct an efficient management system audit.
• Identify organizational deficiencies to ISO 13485:2016 requirements based on evidence collected.
• Apply the principles, methods and processes of auditing.
• Understand how to audit, report and follow-up on nonconformities effectively.
• Overview of ISO 13485, FDA 21 CFR Part 820 Quality System
• Coordinate a quality management system audit
• Management responsibilities to customers, personnel, materials, infrastructure, and facilities
• Audit effectively
• Incident reporting, technical files, and risk analysis
• Prepare nonconformity statements
• Evaluate the significance of audit findings
• Methods for improving communication skills
• Report audit findings and conclusions
• Develop and implement corrective action programs
• Evaluate corrective action responses
• Effectively follow-up audit findings to recognize if the nonconforming situation has been effectively resolved
• Understanding the difference between quality system registration and accreditation
• Preparing specialized checklists for the laboratory environment
• Product realization from planning to design
• Identify the evidence needed to demonstrate conformity

Course Outline:

Day 1

• Quality Management System Overview & Principles
• ISO 13485:2016 Quality Management System Standards Overview
• Management Responsibilities
• Product Realization Documentation
• Design & Development
• Risk Management
• QMS Terminology
• What is an Audit?
• Audit Types
• Audit Evidence

Day 2

• Internal Audit Program
• Internal Audit Team
• Auditor Competence
• Roles
• Audit Techniques
• Four Phases of the Internal Audit Process
• Audit Planning
• Audit Conduct
• Audit Reporting
• Audit Follow-Up

DAY 3 (Audit exercise)

• Development of Audit Plan
• Preparation of the Audit
• Conduct of Management System Audit (mock)
• Draft Nonconformities
• Closing Meeting
• Audit Reporting/Corrective Action Requests

QUESTION & ANSWER TIME - "ASK THE ASSESSOR"

• Gain insight and best practice advice and tips

WHO SHOULD ATTEND

Personnel responsible for planning and scheduling the internal audit program for ISO 13485:2016 and those who must perform audits of the company’s quality management system.

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