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Click for public seminar registration details.
 Certified QMS Lead Auditor Training Course
 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.
Get your lead auditor training from the seminar experts-STAT-A-MATRIX
has been training lead auditors longer than any other training organization.
Objectives
During five rigorous days, you will cover background of the ISO 9000 and ISO 13485
standards, and go through every phase of the audit-from planning to conduct
to follow-up so you will be able to lead your own audits efficiently and effectively.
- QA System Assessment-A proactive approach to quality
assurance in the medical device industry. Covers elements that comprise a
total quality system, including policy, manual, procedures, and instructions.
- Understanding the Requirements-Discuss the requirements
of ISO 9001, as well as those of ISO 13485:2003 and their relationship to
ISO 9001; includes discussion of applicable industry regulations.
- The Audit Cycle-Using ISO 19011, with practical
hands-on workshops, you are introduced to audit functions: preaudit activities;
conducting the audit (assessment); postaudit and follow-up activities.
- Preaudit Activities-Using interactive workshops
(syndicated activities), learn to plan audit activities, develop checklists,
perform preassessment visits, and conduct opening meetings.
- Conducting the Audit (Assessment)-Use hands-on workshops
to learn how to collect objective evidence. Covers active listening and questioning
techniques, as well as methods to help handle confrontations.
- Postaudit and Follow-Up Activities-Through workshops
and assignments, learn how to conduct closing meetings, write effective audit
reports, issue nonconformance forms and corrective action reports, assess
corrective action, close out nonconformances, and conduct surveillances.
Topics
- Overview of auditing
- Interpretation of ISO 13485:2003
- Quality system documentation
- Quality manual and procedures
- The audit cycle and ISO 19011
- Preaudit 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. Ideal for anybody involved in a supplier quality assurance
(SQA) program. While it is suggested that you have some knowledge of ISO 9001,
ISO 13485, or similar quality management systems, there is no formal prerequisite
for this class. This intensive training experience includes mandatory evening
sessions for the first four nights.
This course and the associated examination provide the necessary body of knowledge
and assessment techniques to cover the requirements for registration, when combined
with appropriate documentation of education, professional experience, and auditor
practice. Certified in the United States by RABQSA International, this 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.
NOTE: To attain registration
as a QMS Auditor, QMS Senior Auditor, or QMS Lead
Auditor, you must pass the written final examination, earn a passing grade in
the course continuous assessments, and meet prescribed professional requirements,
including a number of actual audits.
This training course is an RABQSA-certified course and meets the training
requirements for certification of individual QMS Auditors, QMS Senior
Auditors, and QMS Lead Auditors. "Successful completion"
satisfies the training requirements for individual auditor certification by
accrediting bodies such as IRCA, RABQSA, JAB, and CRBA.
NOTE: Additional versions of
ISO 9001 lead auditor training include emphasis on the automotive
(ISO/TS 16949) and aerospace (AS 9100) industries. On-site versions are available
with emphasis on the telecommunications industry (TL 9000) and ISO 14001 environmental
management systems.
CEUs: 4.4
Number of Days: 5
* This course offered in conjunction with ASQ.
Code: L2KF
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