ISO 13485:2016

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Mark Banfield is an accredited Lead Auditor for ISO 13485:2016 and regulatory presents training courses on Implementation and Executive Orientation.

Our Services

  • 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