Now that EN ISO 13485:2012 has been published (in my case BS EN ISO 13485:2012) and the fact that ISO 13485 is current, is this going to cause some confusion? This could especially be the case on certificates, as I've seen examples out there in the ether which indicate EN ISO 13485:2003, which would no no longer be valid (after 31st August 2012 when it kicks in). In our case we have a ISO 13485:2003 certificate - so no need to change.
Just for information the new EN version now has links to the EU Medical Directives Directives.
Any thoughts?
Steve
Just for information the new EN version now has links to the EU Medical Directives Directives.
Any thoughts?
Steve
Some companies are interested in integrating both Quality Management Standards into their business and therefore it is important to compare ISO 9001:2015 and ISO. There are many differences and similarities between ISO 9001 and ISO 13485 and many companies are curious what they are. Huawei windows phone update. Since these are the two biggest quality standards. The publication and release of ISO earlier this year is a significant movement for the medical device industry. The last major revision of this quality management system standard happened back in 2003. 2016 Medical device file While both old and new standards expect the establishment of a special file for each type of medical device, the new standard defines this to include a description of the medical device(s). ISO vs 2016 Conversion Tool. This free tool will help you to convert ISO clauses to the new ISO clauses. Free sales and marketing software. Just select the number of your current clause below and you will find out which clause in ISO corresponds with it, and what kind of changes do you need to perform in your Quality Management System for design and manufacture of medical devices to.
Iso 13485 2003 Vs Iso 13485 2016 Certified
ISO 13485 is the international standard requirements for a quality management system for medical devices. Like many other quality management system requirements for special purposes (such as ISO/TS 16949 for automotive production and service parts and AS9100 for use by aviation, space and defense organizations), the ISO 13485 standard is based on the requirements of ISO 9001. This independence is appropriate considering the difference in context between the two standards, as the 2016 edition of 13485 wants to facilitate the global alignment of regulatory requirements. We maintain that ISO 9001:2015 and ISO are not as aligned as you may have heard.