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.
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
- 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
- Internal Audit Program
- Internal Audit Team
- Auditor Competence
- 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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