Controlling Website Content
I recall that the website is considered a controlled document. Is it necessary to control the entire site, or just certain pages? I'm not exactly sure what QMS processes would apply, and if this needs its own SOP (or if it can be tacked on to another). Any advice would be greatly appreciated. Thank you!
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
In your documented procedure Control of documents, you can state that your particular website is also documented information, but you just need to explain somewhere (maybe in the SOP Control of document or in separate SOP) how do you control the website, who is responsible for the changes on the website, how is the back up provided, how do you collect any information from the customers, how data that customers leave on your website is protected and so on.
For more information on documentation control, please see the following article:
- Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/
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Nov 06, 2020