Question about records

Records are types of documents that provide “proof of existence“, prove that certain process has been done. You need to record all the mandatory records which are directly required by the standard. You can see the List of mandatory documents and records required by ISO 13485:2016 in the following article:

• List of mandatory documents required by ISO 13485:2016 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

Of course, if some requirements are not applicable to you, then you do not need to generate these records. For example, if your product is not sterile, then you do not need to have records of sterilization and sterilization validation in your quality management system.

The purpose of the List of records is to have in one place all your records, to know which record version is currently valid. On that list, there should be all records that you provide within your quality management system: both mandatory records required by the standard, but also any other record that you generate during the execution of your processes, which is proof that some process has been done. This list guarantees the exactness of entered data and prevents unauthorized entry, changes, and destruction of such records.

If by CAPA you mean the records Corrective/preventive action request from our toolkit, that this record needs to be on the List of records.

More information on document management you can find on the following links:

• List of mandatory documents required by ISO 13485:2016 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/
• How to structure Quality Management System documentation according to ISO 13485 https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/