ISO 13485 > Training and Consulting

Oriel STAT A MATRIX provides directed consulting services for ISO 9000 and Related Standards and for FDA-regulated companies.

Our flexible ISO 13485 training and consulting services can help you:

  • Develop a new ISO 13485 quality management system
  • Integrate ISO 13485 with an existing U.S. FDA Good Manufacturing Practice quality system and/or international regulations for medical devices
  • Upgrade from ISO 9001 to ISO 13485
  • Achieve overall business improvement
Our standard training courses include those listed below. Click on any course title for more information.
 
Course Name Public On-site
Advanced Lead Auditor Training
Internal Auditor Training for ISO 13485
Introduction to ISO 13485 Quality Management Systems
Lead Auditor Training for ISO 13485
Understanding an ISO 13485 Quality Management System

Are your audits helping your organization meet its strategic goals? Are you looking to acquire skills to make your audit program the catalyst for tangible improvement to your organization’s bottom line? Click to learn more.

Certified QMS Internal Auditor Training Course
Learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485 and ISO 9001. Click to learn more.

Understand the requirements and benefits of an ISO 13485-compliant quality management system including steps and timing for a typical implementation. Click to learn more.

Based on our ISO 9001 RABQSA-certified QMS lead auditor training course, this interactive course covers ISO 13485 in addition to ISO 9001 requirements for quality management systems. Click to learn more.

Get the information you need to understand the ISO 13485 and ISO 9001 standards and how they impact your organization. Click to learn more.

 

See Training Courses