Contract Review per ISO 13485 sec. 7.2.1, 7.2.2
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No, there is no specific requirement in the ISO 13485:2016 standard that dedicated checkboxes must be used. Simple approvals according to the requirements of 4.2.4 Control of documents are enough.
For more information, please see:
- Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/
- 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/
I have faced before a cituation when an auditor claim that when the standard defined "review that...." the review content must be proven . resently we moved from manualy sales order contract review (with the checkboxes per sec 7.2.2) to ERP system. In the ERP the SO is distributed for approvals as is. your unswer above define this new process as meet the iso requirement - just want to confirm again this issue.
Yes, if the sales order is distributed by the ERP as is, it is OK and enough from the standard point of view.
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Jan 14, 2021