Does ISO 9001:2015 require CSV

Hi my organization is a ISO 13485 and ISO 9001 certified, we have certain product lines that are fully under ISO 13485. Some products line are completely Non-Medical and are under ISO 9001, these products do not share any processes, equipment, and procedures with medical device products. These softwares are not uploaded into any machine, it checks if the product can perform basic operation like move to certain X, Y and Z location to perform certain tasks.

As these tasks are covered in my manufacturing test plan, I believe doing validation for each computer is overkill.

So my question.
1) Is CSV an ISO 9001 requirement.
2) When I point that software validation is not part of ISO 9001 the quality team's counterargument is that 8.5.1 f control of production service provision states the requirement for validation.

Requesting for expert opinion.

 

Standards aside, since you're making quality decisions based on the software, how do you have assurance that the software is operating correctly?

 

Hi, Thanks for replying, and this is my first joining a forum and raising a question, So bit excited. Maybe I will split my question in 3 separate questions. 1) Is it a general practice to perform CSV for ISO 9001 certified product lines, 2) If not what is recommended method to control software in a ISO 9001 production line, 3) Specific to my case what should be my approach?


So to explain the background of the software I use,

1) We build robotic products which are controlled by our company software installed to a laptop or desktop, no inbuilt memory system in the product.

2) Using Software, I teach and train the robot to execute predefined protocols (which is the QC checkpoint). Product expectation is to execute all required protocols and once executed they produce intended results like delivery of 1ul of liquid, moving to x for 200 mm, y for 100 mm etc. Again these indented results are verified using either visual, mechanical or analytical and are recorded.

3) Once the product reaches the customer, they again teach and create new protocols as per their requirement, even integrate third party software to my software and execute either medical or nonmedical environment.

4) Our software is not validated for medical devices, and it is up to customer to run validation of it for their needs.

5) The revision upgrades,
a) done by R&D software team (in US) targets certain customer requirement which we don't test at manufacturing (in Singapore). R&D team verify the software by running either customer test cases or their own test cases.
b) does not affect the core performance (manufacturing test protocols) and in case certain features are added we have separate change management process where we test, verify, record and approve those changes.

6) CSV expectation from quality team is whenever there is an up rev every computer should be validated with master validation plan multiple validation report.

 

Hi Brad,
The Robotic product continuously requires a computer. The teach point is saved in each computer as profile. If I connect with a new computer, I need to reteach and recreate the profiles.

regards,
GP