ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques
ISO 13485 sets out the requirements for a comprehensive quality management system for the design and manufacture of medical devices.The principles of ISO 13485 set out an explicit management system so that you can audit, examine and continually improve systems for a MDQMS.
Obtaining an ISO 13485 LA course will enlighten you to:
- Understand the operations of a Medical Devices Quality Management System based on ISO 13485 standard requirments and sub clauses
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
- Learn how to lead an audit and audit team
- Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
- Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011
- Write factual audit reports that help to improve the effectiveness of the management system by the implementation of appropriate corrective action