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This course is offered in China only and presented in Mandarin Chinese. The course materials are bilingual (English and Chinese). Currently in the industry, especially within China, product requirement development is more of an experience-based process rather than a scientific methodology. This course addresses this issue and provides a more process-driven method for better requirement development through the Quality Function Deployment (QFD) methodology.  Real industrial examples are used to demonstrate how to systematically convert the voice of the customer data to engineering specifications using QFD.

This self paced course reviews the important facets of ISO 9001:2015, the most widely accepted quality management standard.  The standard can be applied to any organization that, regardless of its type or size, needs to demonstrate its ability to consistently provide products and services that enhance customer satisfaction and provide assurance of conformity to customer and applicable statutory and regulatory requirements.  This four-hour ISO 9001:2015 is a high level review.

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system, and how to demonstrate compliance to meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.  Estimated to take up to 15-hours to complete.

This self paced course reviews the important facets of ISO 9001:2015, the most widely accepted quality management standard.  The standard can be applied to any organization that, regardless of its type or size, needs to demonstrate its ability to consistently provide products and services that enhance customer satisfaction and provide assurance of conformity to customer and applicable statutory and regulatory requirements. Estimated to take up to 15 hours to complete,  this self paced course provides training on the standard, and how to lead or conduct internal audits and supplier audits using ISO 19011:2015.  

Created to elevate expertise in testing, verification, and validation with industry-specific terminology, readers are empowered to navigate the complex world of quality assurance. From foundational concepts to advanced principles, each entry provides clarity and depth, ensuring the reader becomes well-versed in the language of precision. This dictionary is an indispensable companion for both professionals and students seeking to unravel the nuances of testing methodologies, verification techniques, and validation processes. Readers will be equipped with the tools to communicate effectively, make informed decisions, and excel in projects. In addition, references to SAE Standards are included to direct the reader to additional information beyond a practical definition.

This self paced course reviews the important facets of ISO 9001:2015, the most widely accepted quality management standard.  The standard can be applied to any organization that, regardless of its type or size, needs to demonstrate its ability to consistently provide products and services that enhance customer satisfaction and provide assurance of conformity to customer and applicable statutory and regulatory requirements.

ISO 14001:2015 is an environmental management standard (EMS) developed by the International Organization for Standardization (ISO). It’s a generic standard that can be used for any organization that provides physical products or services. ISO 14001 is the most widely used EMS because it’s both business and management oriented. However, the requirements must be carefully interpreted to make sense within a particular organization. For example, the environmental impact of developing automotive products is not the same as producing food products or offering consulting services, yet this standard can be applied to any of these activities.

This self paced course reviews the important facets of ISO 9001:2015, the most widely accepted quality management standard.  The standard can be applied to any organization that, regardless of its type or size, needs to demonstrate its ability to consistently provide products and services that enhance customer satisfaction and provide assurance of conformity to customer and applicable statutory and regulatory requirements. 

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

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