Guidelines for getting a record retention policy

Considering ISO 13485:2016, in requirement 4.2.5 Control of records is stated that organization will keep records for at least the lifetime of the medical device, or as specified by applicable regulatory requirements, but not less than two years. It means that if a lifetime of your medical device is six months or one year, you need to keep records for at least two years. 

For more information, please read 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/

You can also check out our book for more information:

• Managing Iso Documentation: A Plain English Guide https://advisera.com/books/managing-iso-documentation-plain-english-guide/