Get 4 FREE months of Conformio to implement ISO 27001

Expert Advice Community

Contract Review Scope

  Quote
Susan Created:   Apr 02, 2024 Last commented:   Apr 05, 2024

Contract Review Scope

What is the scope of contract review?  What triggers a contract review?  We are currently reviewing all POs regardless whether they are for existing parts or for new parts.  It seems like overkill and basically contract review has become a production planning process rather than a contract review process.  The focus is purely on do we have the material and capacity to meet the customers due date. By doing this this, we miss a thorough review of new part requirements because we are overloaded with existing part contract reviews that need to be quickly.

0 0

Assign topic to the user

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Apr 05, 2024

For medical devices, all contracts must be reviewed to be sure that all requirements from the MDR point of view are settled. Whether all contracts will be reviewed depends primarily on whether they are critical parts or parts that can be purchased/acquired anywhere. For critical parts, it is important to be sure that the supplier will inform you of any changes in their product that could affect the quality of the final medical product.

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Apr 02, 2024

Apr 05, 2024