ISO 13485 Internal Auditor

Who should attend

This introductory course is of value to employees at all levels within the organization of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

• New or intended internal auditors
• Internal Auditors without 13485 audit training – OR - Internal Auditors with only 9001 training
• Existing Auditors for refresher purposes
• Lead Auditors without formal 13485 training
• Quality Managers
• Regulatory Affairs Managers

Course Outline

One of the unique aspects of medical device manufacture is the specifically designed quality management system, ISO 13485. It extends beyond the standard ISO 9001 in some very specific ways, and therefore requires specialist knowledge and skills. One of the key requirements of running and maintaining an ISO 13485 complaint Quality Management System is having a programme of internal audits.

Many medical device manufacturers internal auditors are only trained to ISO 9001 standards. This course is specifically designed for medical device companies who need internal auditors to work in an ISO 13485 environment. Internal auditing in a regulated environment requires a different approach and also requires cross consideration of regulations not specifically mentioned in ISO 13485 such as Directive 93/42/EEC or other Quality Management Systems such as 21 CFR 820.

This practical and interactive course introduces delegates to auditing ISO 13485 and how it is integrated with the Medical Devices Directive and other regulations.

You will leave the course with the necessary knowledge and skills base needed to be able to plan, conduct, report and follow-up an internal audit. You will also cover the evaluation of corrective and preventive actions arising from the audits.

Topics covered include

• Overview of ISO 13485 standard including definitions and terms
• Cross linking to other regulations
• The types of audits
• Preparing an Audit Schedule
• Identification of key auditor skills and Auditing Techniques
• Planning a process based audit including resources and timings
• Checklists – development and uses
• Evaluating the significance of audit findings
• Audit Reports
• have a detailed, usable appreciation of the requirements for internal auditing
• understanding of ISO 13485
• have the skills required to plan, conduct, report and follow-up on internal audits

Outcomes

• have a detailed, usable appreciation of the requirements for internal auditing
• understanding of ISO 13485
• have the skills required to plan, conduct, report and follow-up on internal audits