Mark Banfield is an accredited Lead Auditor for ISO 13485:2016 and regulatory presents training courses on Implementation and Executive Orientation.
- New Implementations or upgrades
- Gap Analysis
- Drafting Quality Manual, Quality Policies, Process Flow Charts
- Training – Implementor Training, Employee or Executive Orientation
- Conversion from ISO9001
- ISO 13485:2016 Audits
- Facilitating Management Review Meetings
- Complaints, NCR, Feedback and CAPA Systems Setup
- Integration with other quality management systems such as ISO3834.
- Customer Feedback and Research
- SAHPRA, NRCS, and other regulators, Regulatory Compliance
- Implementation Project Management
- Coordination with Conformity Assessment bodies