Quality System school training courses in Detroit, MI (public, in-house or online)

The Quality Systems Technology program provides a strong background in measurement tools and management systems. It offers maximum flexibility reflecting the needs and backgrounds of individual students. It will provide students with the knowledge and skills necessary to be successfully employed, transfer to a bachelor degree program, and become certified through the American Society for Quality (ASQ). National, international, and industry standards are used extensively. Hands-on training includ...

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Management and new hires within any organization using continuous improvement and corrective-action.

Are you prepared to be a part of continuous improvement (CI) in your organization? All CI programs, many standards, and accreditation bodies require a corrective action/improvement process. This one-day program focuses on the concepts, quality tools, and processes you need to succeed! Topics include teamwork, consensus-building, on-the-job application, and fact-based, problem solving proce...

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This course, designed for ISO program managers, is a complete summary of the ISO 9001:2008 standard. Topics include designing a process for implementing ISO, identifying business processes and quality metrics, and creating level I policy documents and level II procedures. You will use case studies to audit an ISO program and practice the stage 1 and stage 2 registration processes.

This course gives you a complete review of the ISO 9001:2008 standard that includes the process approach to b...

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FDA-regulated organizations must establish and maintain a quality system appropriate for the specific medical device being manufactured and meet the requirements of FDA’s Medical Device Quality System Regulation. QSIT is intended to increase manufacturer compliance, inspectional consistency, product quality, and the efficiency of the enforcement action review process.

Review guidelines for the preparation and management of quality system inspections conducted by the FDA. Understand exactl...

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Our industry experts explain FDA’s Medical Device Quality System Regulation and what it means to your organization. Learn what compliance with this regulation means, current trends toward harmonization and implementation strategies, the primary impact of the regulation on medical device companies, and how to comply with the requirements. Understand how the regulation compares with ISO 9001 quality system requirements, what FDA inspectors look for on establishment inspections, and how design cont...

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