ISO 13485 and Auditing Management Systems Training

Wednesday, Apr 10, 2019, 9:00 am - 5:00 pm

ISO 13485 Course Description (April 10, 2019):

This course is intended to provide an overview of the ISO 13485:2016 Medical devices -Quality management systems - Requirements for regulatory purposes.

 This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing, and final decommissioning and disposal of medical devices.

 This course can be used to formally document training to the ISO 13485 International Standard for internal auditors and external (supplier) auditors.

ISO 13485 Course Topics:

  • Discuss the history of ISO Standards
  • Evaluate the Seven Quality Management Principles
  • Understand the process approach
  • Understand risk-based thinking
  • Identify and discuss common risk management tools
  • Identify and discuss the ISO 13485 clauses including best practices

Auditing Management Systems Course Description (April 11, 2019):

This course is intended to provide an overview of auditing management systems.

 Auditing is essential for providing management insight to compliance and conformance to standards, regulations, guidance documents, requirements, and specifications, performance of processes and systems, and the adequacy and effectiveness of the management system.

 This course can be used to formally document training to ISO 19011:2018 Guidelines for Auditing Management Systems for internal auditors and external (supplier) auditors.

 Auditing Management Systems Course Topics:

  • Review the Principles of Auditing
  • Discuss Audit Program Management
  • Learn How to Plan and Perform an Audit
  • Evaluation of Auditor Competence
  • Discuss the Hierarchy of Documentation
  • Learn How to Write Audit Findings
  • Discuss the Seven Basic Quality Tools
  • Identify the Types of Sampling Plans

Register online here. **Registration of three or more participants from one company is discounted to $475.00 per participant**

Instructor: Mark Durivage

This course is provided in partnership with Greater Memphis Medical Device Council (GMMDC). If your employer is a member of GMMDC, please select GMMDC discount on registration page. Contact MSQPC if you would like to conduct FMEA training on-site for your organization.

« Back