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View Full Version : Process Approach - Implementing ISO 13485 plertlerphunt 16th August 2008, 03:13 AM I'm now looking for implement ISO13485 in our quality system and I realize that I need to create process approach model and add in to our quality manual. Does anyone have example of the model? Let share too then will be great for my implementation Thanks in Advance DannyK 16th August 2008, 10:32 PM All you have to do is to outline the processes to produce the product. It is no different than ISO 9001 except there are specific requirements within ISO 13485 that must be documented. You do not mention the type of medical device you produce or design. If you are more specific, people can respond with better answers. Ajit Basrur 17th August 2008, 02:06 AM Danny is right - the process approach for ISO 13485 is based upon the ISO 9001. JaneB 17th August 2008, 02:08 AM And there's no such thing as a single optimum 'process approach'. The absolutely critical thing is for you to define the processes as they are in your organisation. Ajit Basrur 17th August 2008, 02:18 AM Hi plertlephunt, You could have a look at Introduction and support package Guidance on the concept and use of the process approach for management systems (http://www.iso.org/iso/concept_and_use_of_the_process_approach_for_management_systems) plertlerphunt 18th August 2008, 05:35 AM Thanks for all :D:D:D Tiffany 19th August 2008, 11:40 PM hi, Adopting automotive process approach system would be a good method as well. Tiff:D howste 19th August 2008, 11:55 PM All you have to do is to outline the processes to produce the product. Wait! Don't forget the other processes not specifically tied in to producing product. NOTE: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.(emphasis added) Roland Cooke 20th August 2008, 01:31 PM And Section 4 - documentation requirements, including (but limited to), document control and records control. Dash Jones 21st August 2008, 06:56 AM I know that this will help you get started. In my opinion it is an excellent document which explains the process based approach in details. We used this to develop our QMS. The only caution is that this was developed for ISO13485-2000; however, our gap analysis between 2000 & 2003 showed little change. howste 21st August 2008, 08:33 AM It looks like it was presented in 2005 and was actually developed for ISO 13485:2003. Dash Jones 21st August 2008, 08:40 AM I stand corrected. got confused with another document. thank you for the correction. |
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