Expert Advice Community

Guest

Contract Review per ISO 13485 sec. 7.2.1, 7.2.2

  Quote
Guest
Guest user Created:   Jan 11, 2021 Last commented:   Jan 14, 2021

Contract Review per ISO 13485 sec. 7.2.1, 7.2.2

Please advise if the requirement specified in these sections enforce using a dedicated form (hard copy or electronic) , having the ability to show that all requirement lay out in these sections have been reviewed - meaning dedicated checkboxes . e.g. product requirement are defined and documented , no regulatory constrains, no open user training needs, organization have the ability to meet defined requirements etc... .
Dose simple approvals of operations and QA/RA without using these check boxes is enough to fulfil standard requirement.

0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jan 11, 2021

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:

Quote
0 0
Guest
‪Asher Zilberstein‬‏ Jan 12, 2021

 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.  

Quote
0 0
Expert
Kristina Zvonar Brkić Jan 14, 2021

Yes, if the sales order is distributed by the ERP as is, it is OK and enough from the standard point of view.

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Jan 11, 2021

Jan 14, 2021