Guest
What form of signature does ISO 13485 accepts
The organization I work for is considering ISO 13485 certification in the future. Does ISO 13485 require hand written signatures or are electronic/digital signatures acceptable as long as we use a formal validation of the system for electronic signatures?
Assign topic to the user
Expert
Verlene Law
May 08, 2019
Answer:
ISO 13485 does not dictate the form of signature used. Companies can use electronic documents even without digital signature, it is sufficient to prove that the authorized person has approved them through email or document management system.
Comment as guest or Sign in
May 08, 2019
May 08, 2019
May 08, 2019