ISO 13485 Internal Auditor Training is offered as an on-site 2 day course by Quality Resource Center, Inc.

ISO 13485:2003 Internal Auditor Training for Medical Device Quality Management Systems

Length of course: 2 days/16 hours

Who should attend: ISO 13485 Implementation Team Members, Management Representatives, and ISO 13485 Internal Auditors

Fee Schedule for On-Site Training:
1 to 4 people: $2,520.00
5 to 7 people: $3,780.00
8 to 20 people: $6,300.00

This course includes the required RAB/QSA content for internal auditor training defined in ISO 19011:2002 Guidelines for Quality and Environmental Management Systems Auditing.

Silicon Valley companies: You may schedule consecutive or non consecutive 8 hour days.

Dates: Arranged to meet the scheduling requirements of your organization.

Optional: An additional day of audit practice is available for a fee of $1,200.00. Auditors perform an actual audit that is supervised by the QRC trainer.

Agenda:

1. Introduction

• Historical background
• Why organizations certify to ISO 13485
• Benefits of certification

2. Review of the requirement clauses of ISO 13485

• Clause 4 – Quality Management System
• Clause 5 – Management Responsibility
• Clause 6 – Resource Management
• Clause 7 – Product Realization
• Clause 8 – Measurement, Analysis and Improvement

3. Documentation requirements

• Quality Manual
• Required procedures
• Records

4. Process-based system

5. Auditing Techniques

6. Records and sampling

7. Auditing the ISO 13485 system

• Defining audit scope, objectives, and criteria
• Determining the feasibility of the audit
• Initial contact with the auditee
• Collect documents
• Document review
• Preparing the audit plan
• Preparing the Checklist
• Conducting the opening meeting
• Auditing documented and undocumented processes
• Collecting and verifying information
• Audit findings
• Audit conclusions
• Closing meeting
• Preparing the Audit Report
• Audit follow-up