New QMSR and DHRs, DMRs, etc.

contigo123 · Feb 9, 2024

Just wondering everyone's thoughts/plans with regards to some of the transitions in names. We are currently compliant to the QS Regulation and ISO 13485:2016, so nothing really needs to change in the content of our forms, but, for example, our lot release form is titled "DHR Release Form." Do you all plan to completely do away with the terms (so change the form title to "Batch History Release Form" or similar), or just update the governing procedure to say DHR = batch history record, and call it a day. I know we have 2 years to do this, so I'm also curious about when you would make the change.

yodon · Feb 12, 2024

In theory, the name of the record shouldn't matter as long as the content fulfills the requirement. In theory.

I expect I'll keep the 'legacy' QSR names around and (continue to) equate them to the 13485 equivalents. As I stand up new QMSs for clients, I'll likely start phasing out the QSR terms.

Weeder · Monday at 2:00 PM

contigo123 said:
Just wondering everyone's thoughts/plans with regards to some of the transitions in names. We are currently compliant to the QS Regulation and ISO 13485:2016, so nothing really needs to change in the content of our forms, but, for example, our lot release form is titled "DHR Release Form." Do you all plan to completely do away with the terms (so change the form title to "Batch History Release Form" or similar), or just update the governing procedure to say DHR = batch history record, and call it a day. I know we have 2 years to do this, so I'm also curious about when you would make the change.

I understand that this is going to be a hard switch so you cannot make changes to existing procedures and forms until the 2026 date. I plan to update the procedure and forma and keep them in a separate folder until the time they become applicable.

New QMSR and DHRs, DMRs, etc.

contigo123

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yodon

Weeder

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