ISO 13485 Lead Auditor
Description: Knowledge and skills to:
- Manage the audit team members and the audit process.
- Represent the audit team in communications with the personnel managing the audit programme, audit client and auditee.
- Lead the audit team to reach the audit conclusions.
- Prepare and conduct the audit activities.
- Collect and analyze appropriate evidence to determine the audit findings and define the audit conclusions.
- Prepare and present the audit report.
- Follow up and close the audit process.
Previous skills/knowledge:
- Demonstrable knowledge of ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes and applicable regulation requirements.
- Demonstrable evidence of participation in ISO 13485 audits (>1 audit recommended)
- Professional experience, including in quality management systems and medical devices quality management systems (recommended).
Authorized Partners:
Teaching requirements: - Trainer to be a qualified ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes Lead Auditor.
Objectives to achieve: To get the necessary knowledge and skills to:
- Fully understand and interpret the requirements of ISO 13485.
- Understand the requirements of the applicable regulations and be able to compare these to the requirements in ISO 13485.
- Understand the terminology of the ISO 13485 and how these apply in a Medical Device Environment for regulatory purposes.
- Learn and apply the main terms, principles, and techniques used during the activities of the audit process, according to the responsibilities assigned to a lead auditor, for the assessment of an ISO 13485 Medical Devices Management Systems, based on the ISO 19011 guidelines for auditing management systems
