ISO 13485:2016 is a standard covering the requirements for Medical Devices whether in contact with Humans or animals or without any contact. The medical devices are said to be in contact if the device remains in contact with the human or animal for more than 24 hours. These could be like dental implants or pacemakers, and other similar aids. Whereas items like crutches, wheelchairs, dental chairs etc. Are considered as non-contact medical devices since the contact with these items has no bearing on the health of Humans or animals and is not continuous.
This one-day interactive session provides clear concepts, terminology and fundamentals to effectively implement the standard. Cost effective implementation techniques and process approach in conducting audits for bottom-line results, are emphasized.
It may be remembered that although this standard was revised in 2016 the standard, the technical committee of writers for ISO 13485:2016 have chosen not to revise this standard for high level 10 element structure in line with ISO 13485:2016, instead they have chosen to continue with ISO 9001:2008 as their base principle of quality standards. Consequently, the standard has retained the need for producing documented processes which is not the case with ISO 13485:2016.
Including the Medical Devices Quality Management System is a thoughtful selection by any management, based on their needs. Objectives, the type of products provided, the processes required, size and structure of the organization. The standard does not insist that all managements follow a uniform quality management system, nor a uniform documentation system.
Finally, the course emphasizes the effective methods of documented information and the advantages of a simplified and comprehensive one level documentation. This one level documentation is an evidence-based system which offers proof of implementation for the standard’s requirements. This 1-day on site implementation training course includes explanations on Terms, Concepts and Principles covered in revised ISO 13485:2016 standard.