Brief course description...

BSI’s “Introduction to: ISO 13485” one day course has been designed to provide an insight into the use of ISO 13485:2003 as the basis for a quality management system implemented by medical device manufacturers.

Time will be spent during the course reviewing requirements of ISO 13485 and making comparisons to ISO 9001:2008 and the FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485 and ISO 14971:2007, “Application of Risk Management to Medical Devices”.

Brief course description...

BSI’s “Implementing: ISO 13485” two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2003 certification.

The course introduces the concepts needed to understand, develop, and implement a quality management system.

Brief course description...

BSI’s “Internal Auditor: ISO 13485” course is intended for medical device quality professionals aiming to build on their current knowledge of ISO 13485:2003 and evaluate the effectiveness of the quality management system in their organization. This intensive two-day course teaches the principles and practices of effective quality management systems process audits in accordance with the ISO 13485 and ISO 19011:2002.

An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.

IRCA Certified Course (A17070)

Brief course description...

BSI’s “Lead Auditor: ISO 13485” course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485:2003 and ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing.”

Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

Important to delegates

This examination is 'closed book'.
Participants may use their copy of the requirement standard and a dictionary - these are the only items permitted for reference.

Brief course description...

Attend BSI’s “Introduction to CE Marking” one day course and start making informed decisions with regard to meeting the requirements of the EU Medical Devices Directives.

On completion of training, participants will be able to identify the steps required to reduce the risks and uncertainty in the EU regulatory process and thus bring products to the EU market more quickly.

Brief course description...

BSI’s “Lead Auditor: ISO 13485” course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485:2003 and ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing.”

Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

Brief course description...

BSI’s “Medical Devices CE Marking” three day course is designed to provide participants with the knowledge to assist their companies in getting products to market more quickly. Management personnel responsible for all aspects of CE marking medical devices as well as internal and external auditors will benefit from this course.

Participants will gain knowledge of the requirements of the Medical Device Directive and the CE Marking approach. Participants will be able to provide leadership for their organizations when placing medical devices on the market in the European Union.