Changing supplier

Hello everyone,

Is a design change necessary when switching suppliers? we have ISO13485 CERT.

thank you in advance.

What does the current supplier provide you with and what would you change in case you qualified the candidate supplier?

What do you mean by a design change?
Are you thinking that the part(s) or materials from a new supplier must be validated to work in your design? if so then YES.

planB said:

What does the current supplier provide you with and what would you change in case you qualified the candidate supplier?

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the current supplier provides us with plain label that are classified within our system as non critical materials.
Purchasing department is not happy with the current supplier and would like to keep him on our supplier list and add the candidate one which suppose to provide label that meet our current specification. as QA (new in the field) i suggest first to order sample from the candidate supplier to run internal study to ensure they meet our specification then have the new supplier added to our supplier approval list. what do you think?

Bev D said:

What do you mean by a design change?
Are you thinking that the part(s) or materials from a new supplier must be validated to work in your design? if so then YES.

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I would like to record this change within the system, as it is necessary to demonstrate that the materials supplied by the new supplier meet our specifications. To provide evidence, we need to conduct a validation study. From my perspective, this documentation could be included in the early stages of the design change process!.

Qualifying a second supplier for a label material, that meets the very same initial specification, is typically not a design change. You may want to plan and carry out your V&V activities within your established change control process, though. Another more formal reason to carefully consider whether you really have a design change is, that design changes may be reportable.

FDA has a checklist for significant change flowchart so do other certification providers. Main questions 1) Is there a change in performance? 2) Does testing reveal new uncontrolled risks?

A plain label? THIS is why the original post would contain as much detail as necessary to describe the actual situation. We cannot provide good advice if we don’t know the details.

IF we believe that the label is truly non critical and that has been validated (that there is no effect on the product if the label is missing because it won’t stay adhered, has missing information because the ink won’t stick or other causes) then there is no ‘validation’ would be required. A simple verification that all specified characteristics are met is probably enough.
BUT you haven’t given us any real information that can help us help you.
planB and Ed have given you very helpful advice. Only your organization can answer the questions I have outlined. So, what happens if the label falls off? What is the purpose of the label? What is the label not supposed to? (Outgas somethign that can effect your product?).

I know very little about ISO 13485, but UL has very stringent requirements on the permanency of labels. This covers the adhesive, the label stock and the ink. Does ISO 13485 have anything similar?

For medical devices, there are product specific, vertical standards (the ISO 14708 series being an example for active implantable devices) and horizontal standards, such as ISO 11607-1:2019, section 5.4 or ISO 20417:2021, section 6.4, that contain physical requirements @Miner is discussing.