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Training: Quality Management Systems - ISO 13485 - FDA/QSR - CMDCAS |
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Qserve’s Quality Management Systems training courses center on the “process approach” for quality management systems as outlined in ISO 13485 “Medical Devices - Quality Management Systems – Particular requirements for regulatory purposes”. For those medical device manufacturers operating in jurisdictions besides the EU: ISO 13485 is inherent to Canadian (CMDCAS) and Australian (TGA) requirements. The FDA Quality Systems Regulations (QSR) and their relationship to ISO 13485 are elaborated in the QSR course.
All Qserve QMS trainers have had many years of practical experience in this area and have proven track records at senior levels. Qserve Consultancy, in cooperation with Qserve America has developed a number of courses for medical device professionals in the area of Quality Management Systems (QMS) including:
These courses can be delivered in English or in Dutch, at Qserve offices, external locations and onsite at your own location in the EU or US.
Please note! For the Benelux, the two-day course on ISO 13485 marked with an asterisk is provided in partnership with NEN, the Dutch Standardization Institute and as such must be booked through the NEN website (see below). This course is normally conducted in Dutch. If preferred, it can be given in English. The one- and half-day courses are given and organized by Qserve in co-operation with the NEN and should be reserved via Qserve. Course Code QMS1 *ISO 13485:2003 Medical Devices - Quality Management Systems – Particular requirements for regulatory purposes (2 days with an exam)(This course must be booked through the NEN website)Course Description:This intensive two-day course, run by highly experienced consultants, is intended to give participants a broad understanding of the requirements of ISO 13485 and to provide them with the tools necessary to, develop, implement and maintain a quality management system based on this standard. The course focuses on the “process approach” required by ISO 13485 and how this is best achieved; an activity which receives inputs and generates outputs from these inputs can be described as a “process. in order for an organization to function effectively, it must identify and manage numerous “linked” processes. It looks at ISO/TR 14969:2005 “Medical devices- quality management systems- guidance on the application of ISO 13485:2003”. The requirements of the European MDD in relation to ISO 13485 are also systematically incorporated. Topics covered include: setting objectives and defining responsibilities; design and development; purchasing; production; document requirements and control, customer satisfaction, guidance in writing a Quality Manual; audit preparation; process validation; monitoring and traceability, control of monitoring and measuring devices; analysis of data and improvement. Etc. . [read more...] Course code QMS2 ISO 13485:2003 Medical Devices - Quality Management Systems – Particular requirements for regulatory purposes “Refresher Course” (1 day)(This course must be booked through the Qserve website) Course Description:This one-day “refresher” course offers medical device industry professionals the opportunity to immerse themselves in the requirements of ISO 13485. The “best practice” for development, implementation and maintenance of a quality management system according to ISO 13485, is considered. Current thinking in the interpretation of ISO 13485 is reviewed. [read more...] Course code QMS3 Introductory course/workshop "ISO 13485: 2003 for Managers" (half day)Course Description:This half-day course has been specifically designed to provide medical device industry executives and senior managers with the knowledge required to successfully oversee the implementation of ISO 13485, and to understand their role in this process ISO 13485 requires management at the most senior levels to determine the quality policies from which objectives should be developed, to communicate these to the relevant personnel and to ensure that these objectives are met. [read more...] Course code QMS4 Quality Systems Regulations (QSR/FDA)(The content of this course is currently under review and will be posted shortly.) For more information about these courses, please complete the info request form in the "Contact Us" section, quoting the course code. |
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