The Batalas ISO 13485 Lead Auditor training course is suitable for those wishing to conduct internal and external audits to ISO 13485.
This 5-day ISO 13485 Lead Auditor training course enables delegates to plan, lead and report audits within their own organisation, their suppliers and with third party organisations. Our ISO 13485 lead auditor training course will enable you to conduct effective audits in any auditing situation.
The format of the ISO 13485 lead auditing training course is highly interactive, with tutor-led sessions interspersed with individual and group exercises. An case study is used to practice auditing skills.
This course is vital for any professional that is involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier quality assurance program.
ISO 13485 specifically requires that staff are trained and that auditors are competent, this course satisfies this requirement.
A detailed understanding of:
- Types of audit
- Audit objectives
- Audit scope and criteria
- Audit responsibilities
- Interviewing skills
- Team leader skills
- The audit process
- Preparation and planning
- The opening meeting
- Checklist development
- Document review
- Conducting and leading on-site audit activities
- The closing meeting
- Reporting audit findings
Book this course and get our ISO 13485 e-Learning course free of charge (normally £49). It gives you an overview of ISO 13485:2016 and is designed and authored by our industry experts and includes interactive exercises, videos and additional learning