Course/Product Description Title: Auditor/Lead Auditor Training for ISO 13485 Metropolitan Area: San Francisco Event Venue: TBD Address: San Francisco, CA Contact Phone: 770-410-9441 Starting Date / Time: 11/30/2009  -  7 am - 9 pm (M - Th) / 8:30 am - 10:30 am (F) EST Duration: 5 days Description: 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. We have 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: pre-audit activities; conducting the audit (assessment); post-audit and follow-up activities Pre-Audit Activities Using interactive workshops (syndicated activities), learn to plan audit activities, develop checklists, perform pre-assessment 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. Post-Audit 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 non-conformances, 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 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. 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. Registration Information 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. This course offered in conjunction with ASQ. Licenses / Designations / Educational Credits: CEU All US States: 4.4 All Canadian Provinces: 4.4 About The Provider: Founded in 1968, STAT-A-MATRIX is the world's leading consulting and training organization dedicated to improving business processes, management systems, and quality and regulatory compliance. We offer ongoing consulting and training in every aspect of business process improvement. Our approach is a unique blend of concepts, methods, techniques, and tools designed to transfer skills and knowledge to your organization's personnel. Our distinct approach integrates quality, regulatory, and business management systems to help improve your bottom line. Price: $1,995.00 More Info: Contact Us For More Information To order this product by check/invoice or credit card, enter desired quantity here >>> Qty:

Keywords For This Course:
QMS, ISO standards, SQA