Registration
Certified QMS Lead Auditor Training Course
Feb 14, 2011
Copenhagen, Denmark
Learn how to assess compliance with ISO 9001 and ISO 13485:2003 from the industry experts. Based on our ISO 9001 RABQSA-certified QMS lead auditor training course, this interactive course covers the ISO 13485:2003 and ISO 9001 requirements for quality management systems.
Objectives:
During this 5-day course you will cover background of the ISO 9000 and ISO 13485 standards as well as every phase of the audit, from planning to follow-up. After successful participation and graduation you will be able to lead audits efficiently and effectively. The course include:
- QA System Assessment: Covers elements that comprise a total quality system, including policy, manual, procedures, and instructions.
- Understanding the Requirements: Requirements and relationship of ISO 9000 and ISO 13485:2003
- The Audit Cycle: Using ISO 19011, with practical hands-on workshops covering pre-audit activities; conducting the audit (assessment); post audit and follow-up activities.
- Pre-audit Activities: Learn to plan audit activities, develop checklists, perform pre-assessment visits, and conduct opening meetings.
- Conducting the Audit (Assessment): Learn how to collect objective evidence. Covers active listening and questioning techniques, as well as methods to help handle confrontations.
- Post-audit and Follow-Up Activities: Learn how to conduct closing meetings, write effective audit reports, issue non-conformance forms and corrective action reports, assess corrective action, close out non-conformances, and conduct surveillances.
Topics at a glance:
-
Auditing
- Interpretation of ISO 13485:2003
- Quality system documentation
- Quality manual and procedures
- The audit cycle and ISO 19011
- Pre-audit activities-opening meeting and checklists
Auditing practices:
- The psychology of auditing
- Nonconformity reporting
- Performing the audit
- Closing meeting
- Process auditing
- Report writing
- Final report
- Follow-up and corrective action
- Final examination (2 hours)
Who Should Attend:
The program was originally designed to train third-party auditors, however, 98% of the program participants lead their company's quality system implementation and/or audit programs. We suggest that you have some knowledge of ISO 9001, ISO 13485, or similar quality management systems but there is no formal prerequisite for this class.
This intensive training experience includes mandatory evening sessions for the first four nights. Certified in the United States by RABQSA International, recognized by IRCA in the UK this STAT-A-MATRIX Institute course meets the training portion of the requirements for certification of individual Quality System Provisional Auditors, Auditors, and Lead Auditor and meets the requirements for QMS Senior Auditor training.