3.6. Documents of external origin

1. In the section 3.6 Documents of external origin- in Procedure for document and record control. There is a line saying- “Each external document that is necessary for the planning and operation of the QMS must be recorded in the incoming mail register“

This is basically all emails, from purchase, sales, quality etc etc. basically everyone email that needs to be registered because it can be necessary for the planning and operation of the QMS. This makes it completely inefficient to run the company.

What is the absolute minimum to do here?. We have several different systems that track important emails and documents. We have a program for QMS- to handle all documents- we have a ERP system to track all sales/production/shipments. This email registering system will break us. Why do we need it? Please advise.

No, you do not need a e-mail incoming register. Here, the incoming register meant all those paper documents that come to your company by regular mail (for example, contracts with suppliers, contracts with customers, some correspondence from regulatory institutions, if your orders come by mail). Of course, if everything is via email, then you don’t need this part. That is, describe here exactly what you wrote in your question: „We have several different systems that track important emails and documents. We have a program for QMS- to handle all documents- we have an ERP system to track all sales/production/shipments.“

What is most important here is that you have control over incoming documents, that you know exactly when which document came and where it was stored or to whom it was forwarded.

2. In iso 13485. It only states: “ensure that documents of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled”

SO why does the tookit refer to that we have to have an advanced document email document system.

Everything has already been answered in the previous question.