The Standard is supported by a guidance document - Medical Devices A practical guide, advice from ISO/TC 210. The Standard is based on the approach of the general Quality Management System Standard, ISO 9001.
NSAI can offer registration to ISO 13485:2016, which sets out the requirements for a quality management system (QMS) applicable to designers and manufacturers of medical devices. Presentation - NSAI ISO 13485 & MDR Seminar, May 2016.You can also receive information on NSAI seminars direct by subscribing to the NSAI E-zine. Quite an accomplishment and it shows that the USA is leading the way in compliance.
The United States has the highest uptake of ISO 13485 in the world commanding 30 of all certifications worldwide. Question: The company's manufacturing process may not be ready for audit but its design and development processes will be. ISO 13485 is based on ISO 9001 with a particular focus on Medical devices (of course). Please follow the NSAI Seminars web page for information on any future events as it becomes available. With regard to ISO 13485:2016 scope of certification, a device company would like to establish a QMS and be granted a QMS certificate before regulatory approval. NSAI held two morning seminars, one in Dublin and one in Galway, on ISO 13485:2016 & the MDR, the presentation given at these events is available below. ISO 13485:2016 Technical Questionnaire (MS Word copies are available from your NSAI auditor) ISO 13485 incorporates ISO 9001 but adds or amends relevant sections to. This latest NSAI presentation is now available to view hereĭocuments referenced during this presentation: ISO 13485 is, effectively, ISO 9001 specifically for medical device manufacturers. The auditor will determine whether the QMS meets the latest edition of the ISO 13485 standards and whether the QMS is in active use throughout the organization. Hosting a seminar in both Dublin and Galway NSAI Medical Device staff gave presentations on the transition to, and what's new in, ISO 13485:2016 and the major changes and impacts on industry of the MDR. The final step in the certification process is to invite an official ISO 13485 auditor to review the companys QMS procedures. The NSAI Medical Device department has just completed its latest Roadshow on 'ISO 13485:2016 and the MDR - Major Changes and Impacts'. ISO 13485 – quality management systems for medical devices