ISO EN 13485:2016 is the global Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell. Notified Bodies can use this standard when assessing whether companies have a QMS, which meets European Regulation requirements. Such an assessment is required where a manufacturer seeks to apply the CE mark. This means that companies must be conversant with ISO EN 13485:2016, the significant aspects of the regulations, relevant guidance standards and the CE mark process.
On training completion you will be able to:
- Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC
- Know how to conduct quality system audits
- Understand the role of audits in the maintenance and improvement of management systems
- Plan and prepare for an audit
- Learn to gather evidence by observation, questioning and sampling
- Write factual reports on the compliance of the management system against the audit standards
- Participate in the corrective action process
The training comprises presentations, workshops and interactive role-play exercises.