ISO 13485 Certified Internal Auditor

  • Delivery Option: Public & On-Site
  • Subject Category: Auditing
  • Cost: $1295
  • Number of Days: 3 days

Course Summary

This course is for those responsible for planning and scheduling an internal audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance professionals, ISO Project Managers, ISO Project Team Members or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry.

Course Objectives

  •  Fully understand and successfully interpret the ISO 13485 requirements
  •  Understand how to audit using the process approach
  •  Ask audit questions that get results
  •  Identify and document nonconformities
  •  Audit to the ISO 9001 Quality Management Systems
  •  Qualify additional staff to conduct internal audits
  •  Provide critical knowledge for your management staff
  •  Gain insight into the ISO 13485 audit requirements to augment/sustain your existing program
  •  Gain knowledge to help manage a successful ISO 13485 implementation project
  •  Provide professional credentials to your internal auditors
  •  Conduct an audit against the ISO 19011 Audit Standard
  •  Provide critical knowledge for your staff and management
 

Benefits

This course is certified in the Exemplar Global Certification Program, and meets the training portion of the requirements for certification of individual Quality Management System Internal Auditors.
Note: This course covers the ISO 13485:2016 revision as well as ISO 9001:2008, ISO 13485:2016 is not aligned with ISO 9001:2015. Therefore, ISO 9001:2015 is not covered as part of this course.

Agenda

Day One
  •         Terminology and Definitions
  •         Background, History and Rationale for Quality Assurance
  •         Introduction to the ISO Family of Documents
  •         Analysis of the Contents of ISO 13485
  •         Audit of the Active Medical (Audit #1)
  •         Quality System Requirements
  •         Analyzing Audit Findings
  •         Exemplar Global and U.S. Certification System
  •         Auditor Qualifications
  •         Roles and Responsibility of Auditors
Day Two
  •         Creation of Effective Audit Checklists
  •         Audit of Company Documents (Audit #2)
  •         Tips for the Internal Auditor
  •         Audit of Active Medical – Department Audit (Audit #3)
  •         Compiling Audit Findings
  •         Documentation in the Quality System
  •         Planning and Conducting Effective Audits
  •         Refining Interview and Note-Taking Skill
  •         Applicability of the Clauses to Company Situations
Day Three
  •         Audit of Active Medical – Dept and System Auditing (#4)
  •         Corrective Action Initiation and Closure
  •         Refining Audit Interview and Note-Taking Skills
  •         Creation of an Audit Report
  •         Preparation and Presentation of a Closing Meeting
  •         Review & EXAM