Medical Devices Quality

ISO 13485 Foundation

This course enables the participants to learn about the best practices for implementing and managing a Quality Management System (QMS) as specified in ISO 13485, as well as ISO 14969 (Medical devices – Quality Management Systems – Guidance on the application of ISO 13485). The participant will learn the different components of a QMS manual, required procedures, records, measuring performance, management’s commitment, internal audit, management review and maintaining effectiveness.

ISO 13485 Lead Auditor

This five-day intensive course enables the participants to develop the necessary expertise to audit a Quality Management System (QMS) based on ISO 13485 and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this training, the participant will acquire the necessary knowledge and skills to proficiently plan and perform internal and external audits in compliance with ISO 19011 and certification audits according to ISO 17021. Based on practical exercises, the participant will develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, communicating with customers, conflict resolution, etc.) necessary to efficiently conduct an audit.

ISO 13485 Lead Implementer

This five-day intensive course enables the participants to develop the necessary expertise to support an organization in implementing and managing a Quality Management System (QMS) based on ISO 13485. Participants will also gain a thorough understanding of best practices used to implement quality processes based on requirements from ISO 13485. This training is consistent with the project management practices established in ISO 10006 (Quality Management Systems – Guidelines for Quality Management in Projects). This training is fully compatible with ISO 14969 guidance’s (Medical devices – Quality Management Systems – Guidance on the application of ISO 13485).

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