Internal Auditor Training for the Medical Device Industry based on ISO 13485.
This 2-day ISO 13485 Internal Auditor course is designed to provide the latest information on Quality Systems Regulations (QSR) and product safety requirements, providing delegates with practical auditing techniques in order to conduct effective audits against the requirements of ISO 13485 and QSR requirements.
- Complying with FDA and CE Marking requirements – the requirements of ISO 13485 and QSR
- Principles of auditing, the audit cycle and audit objectives
- Auditing skills and techniques:
- Planning – use of checklists, resources and timing
- Selection of audit teams and training
- Interviewing and evaluation of information and findings
- Observation – objective evidence
- Evaluating the significance of nonconformities
- Communicating and presenting audit reports
- Corrective actions and effective follow-up programmes
- Effective improvement – planning, monitoring and results
- Preparing for an FDA QSIT type audit.
- Sources of information and further development
Who Should Attend
- Executives and Senior Management
- Design Engineering
- R&D Managers/Engineers and Members of Design Review Teams
- Regulatory Affairs/QA Managers and Management Representatives
- Members of multi-discipline Design Teams
- Sales and Marketing, Production, Shipping, MIS, Purchasing
ISO 13485 Internal Auditor Training Outcomes
By the end of this ISO 13485 Internal Auditor course, delegates will be able to:
- Interpret the requirements of ISO 13485 as it relates to management system standards.
- Plan, manage and objectively assess the compliance of an organisation’s management system in relation to ISO 13485 / QSR requirements.
- Prepare for an FDA QSIT-type audit and add value to an organisation’s management system.