ISO 13485:2016 Internal Auditor Training
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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Location:
Labtopia Classroom
12929 Gulf Freeway, Suite 108
Houston
,
TX 77034