Description:
This course covers the requirements of the ISO 9001 and 42 CFR 84 standard and is based upon ISO 19011 Guidelines for Quality and/or Environmental Management Systems Auditing Participants are taught how to plan, conduct, and report the results of a Quality Management System Audit. The course contains ten (10) practical exercises which students complete both individually and in a team environment to gain auditing competence. Day 3 includes a live audit conducted by the students of their organization’s own QMS.
Topics Include:
- Reviewing the requirements of ISO 9001 and 42 CFR 84
- Process Auditing
- Audit Planning
- Audit Execution
- Audit Reporting
- Nonconformances (including types)
- Corrective Action (including verification)
Those individuals within your organization who will be conducting internal QMS audits and who meet the personal attributes stated in ISO 19011. Students must have a basic understanding of the ISO 9001 and 42 CFR 84 requirements and be familiar with their organization’s own quality management system.
Maximum/Minimum Participants:
4 people minimum, 15 people maximum.
Duration:
3 Days
Type:
On-Site & Virtual Training
Price:
$7,500.00/course plus course manuals and travel expenses for the instructor