Course Criteria

This course is based on the ISO 19011 criteria and meets in-house training requirements for Internal Auditors. A one hour optional exam may be given and Internal Auditor certificates are awarded to those meeting passing test score requirements. Certificates of participation are provided to all students.

1-Day Option

• Introduction to ISO 13485:2003
• A Recap of the ISO 13485:2003 Elements
• What to Look For As an Auditor
• Auditing Techniques
• The Audit Schedule & Auditor Assignments
• Developing a Checklist (in-class exercise & examples)
• Auditing & Questioning Techniques
• How to Write an Audit Report (in-class exercise & examples)
• The Corrective Action & Re-audit Process
• Wrap Up

This 2-day option gives 2 full days of classroom time, allowing for a slower pace in reviewing the details of each TS element with more time for questions and answers.

Day 1

• Introduction to ISO 13485:2003
• A Recap of the ISO 13485:2003 Elements
• What to Look For As an Auditor
• Auditing Techniques
• The Audit Schedule & Auditor Assignments
• Developing a Checklist (in-class exercise & examples)
• Auditing & Questioning Techniques
• How to Write an Audit Report (in-class exercise & examples)
• The Corrective Action & Re-audit Process
• Wrap Up

• Auditing Techniques
• The Audit Schedule & Auditor Assignments
• Performing a Desk Review to the Requirements ( in class exercise & examples)
• Developing a Checklist (in-class exercise & examples)
• Auditing & Questioning Techniques
• How to Write an Audit Report (in-class exercise & examples)
• The Corrective Action & Re-audit Process
• Wrap Up

This 3-day option gives 2-days of classroom time, followed by a 1-day "hands-on" audit of your system performed by course participants. An Opening Meeting and Closing Meeting are conducted, with Audit Reports and Corrective & Preventive Actions created by participants. You may claim credit for this audit as an actual internal audit and show it as audit evidence to your Registrar.

Day 1

• Introduction to ISO 13485:2003
• A Recap of the ISO 13485:2003 Elements
• What to Look For As an Auditor
• Auditing Techniques
• The Audit Schedule & Auditor Assignments
• Developing a Checklist (in-class exercise & examples)
• Auditing & Questioning Techniques
• How to Write an Audit Report (in-class exercise & examples)
• The Corrective Action & Re-audit Process
• Wrap Up

• Auditing Techniques
• The Audit Schedule & Auditor Assignments
• Developing a Checklist (in-class exercise & examples)
• Auditing & Questioning Techniques
• How to Write an Audit Report (in-class exercise & examples)
• The Corrective Action & Re-audit Process
• Wrap Up

• Performing an Actual Audit of Your Quality System
• Audit Scope & Elements to be Audited
• The Opening/Introductory Meeting
• Developing the Audit Report
• Developing Corrective and Preventive Actions
• The Closing/Outbriefing Meeting with Audit Results (with company mgt)
• Wrap Up

• Understand how to conduct an internal audit
• Understand how to correctly develop the audit report
• Understand how to identify and write Corrective & Preventive Actions

This course includes interactive workshops designed for the students to simulate audit experience by immediately putting into practice the techniques for audit preparation, audit execution and audit administration. Some classes actually participate in an on-site practice audit to the ISO 13485:2003 requirements, utilizing both classroom and simulation exercises learned.

Successful Course Completion

A certificate of completion is provided to each student that a) meets course attendance and performance requirements, and b) demonstrates attainment of the Learning Goals by passing am optional written examination administered the last day of the course.

Course Cost & Instructor

The course held on-site, is fee based on daily flat feet, with no limit on students attending, provided a workbook for each student is purchased. Only on-site courses are offered. Please contact us for a quotation and Instructor background information.