For quite some time, the medical device industry has debated whether records are or are not documents.
In ISO 13485:2016, it was clarified that “document” includes “document” and “record”.
However, in 4.2.4 Document Management, it is stated that “However, records are a type of document, they are managed in accordance with the requirements specified in 4.2.5. “.
In other words, “records” are a type of “documents” but the management method is different between “documents” and “records”.
Generally, when we refer to “documentation” in regulatory requirements or international standards, we mean QMS (Quality Management System).
Records would be created by operating the QMS.
Often we see companies including “records” in their QMS, but this is not appropriate. This is because “records” are not a system (mechanism).
What is the difference between the management of “documents” and the management of “records”?
Document Management
ISO 13485:2016 4.2.4 Document control has the following requirements
a） Review and approve documents for appropriateness prior to issuance.
In other words, the document must be reviewed and approved.
b） Review documents. Also, update and re-approve as necessary.
Review in this context should be interpreted as “review”. Documents should be reviewed and revised on a regular basis.
c） Ensure identification of the current revision of the document and identification of changes.
This means that the latest version must be identified (usually by making only the latest version available) and the history of changes from the previous version must be noted.
In addition to the above, control over distribution must be ensured so that obsolete documents are not misused.
Records Management
On the other hand, ISO 13485:2016 4.2.5 Management of records requires the following
Create and maintain records to demonstrate conformance to requirements and evidence of effective operation of the quality management system.
As mentioned above, the “record” is the result of the operation of the QMS.
Note that “records” differ from “documents” in that there is no review or approval requirement.
It is necessary to define “records” that need to be properly reviewed and approved by the company’s QMS and those that do not.
For example, meeting minutes would not necessarily need to be reviewed and approved. However, minutes of a design review may need to be reviewed and approved.
The difference is that the decision must be based on whether or not the “record” in question affects the quality, safety, or efficacy of the product.
Changes in records shall be identifiable.
As noted above, “documents” must be reviewed periodically. However, changes to “records” may constitute tampering.
Therefore, it would be necessary to change the “record” only when there is a valid reason, in the manner defined in the QMS, and keep a record of the change history (or audit trail in the case of electronic records).
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