Course Summary
This course is for those responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry.
Target Audience
Those responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry.
Course Objectives
- Fully understand and interpret the requirements of ISO 9001 in a Medical Device Environment
- Fully understand and interpret the requirements of ISO 13485
- Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
- Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
- Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
- Understand how to apply the requirements of ISO 9001 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class
- Understand the terminology of the ISO 9001 and ISO 13485 and how these apply in a Medical Device Environment
- Learn how to develop an ISO 9001 / ISO 13485 auditing system based on the ISO 19011 auditing requirements
- Learn how to ask audit questions that get results
- Learn how to conduct opening and closing meetings that have impact
- Learn how to construct effective audit checklists
- Learn how to generate effective corrective actions
Benefits
Agenda
- Terminology and Definitions
- Background, History and Rationale for Quality Assurance
- Introduction to the ISO Family of Documents
- Analysis of the Contents of ISO 13485
- Audit of Active Medical (Audit #1)
- Quality System Requirements
- Analyzing Findings
- Audit of Active Medical to ISO 13485 (Audit #2)
- Exemplar Global and U.S. Certification System
- Auditor Qualifications
- Roles and Responsibility of Auditors
- Creation of Effective Audit Checklists
- Audit of Active Medical – Document Audits (Audit #3)
- Tips for the Professional Auditor
- Audit of Active Medical – Department Audit (Audit #4)
- Compiling Audit Findings
- Documentation in the Quality System
- Planning and Conducting Effective Audits
- Refining Interview and Note-Taking Skills
- Applicability of the Elements to Company Situations
- Prevention vs. Detection
- Audit of Active Medical – Department and System Auditing (#5)
- Corrective Action Initiation and Closure
- Refining Audit Interview and Note-Taking Skills
- Creation of an Audit Report
- Conducting the Audit
- Preparation and Presentation of a Closing Meeting
- Review & EXAM