Additionally, the CAPA form provides a structured approach to documenting the requirements mentioned in FDA 21 CFR Part 820.100 and ISO 13485:2016 Clause 8.5. For example, these requirements mandate documenting
or any other aspect of the standard, but rather about the product safety. One of the many additions brought about by the new version of the standard involves new and expanded requirements regarding product and process safety. In the ISO/TS 16949:2009 version of the standard, safety...