(This course must be booked through the NEN website)

Course Code QMS1

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.

This course is based on practical examples, case studies and exercises, which are useful for direct implementation.

At the end of the two days, participants will be required to show that they have acquired the relevant know-how and skills by taking a short exam.

Course Objectives:

• To provide participants with a broad understanding of the requirements of ISO 13485
• To guide participants in the practical application of the “process approach”
• To enable participants to successfully interpret all clauses of ISO 13485 (in relation with the MDD)
• To give participants the necessary practical tools for development, implementation and maintenance of a quality management system based on ISO 13485.
• To guide participants in the preparation of Standard Operating Procedures (SOPs), Flow Charts, Forms etc.

Who should attend:

This is an introductory course intended for those with little knowledge of ISO 13485. However, familiarity with medical devices and ISO 9001:2000 is essential. The course is aimed at:

• All QA/RA Personnel involved in the implementation of ISO 13485
• QA/RA Managers
• Management Representative
• Product and Production Managers
• Start-up Companies

Course Materials:

Participants will receive a comprehensive course manual with reference materials, and, upon successful completion of the course and exam, a “certificate of attendance and successful completion”.

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