Hello,
I am working in a start-up (no product on the market, first product still under development) and we are ISO 13485:2016 certified since early this year. During the certification audit, our auditor made an oral comment regarding our purchasing procedure : our criteria for supplier selection shall be reviewed and improved (we didn't get a deviation but a very insisting oral comment!)
Here is what is currently written in our procedure:
"The supplier is selected according to the following criteria:
The price,
The ability to meet deadlines,
The ability to meet specifications relative to the product / process or service,
The quality insurance, if appropriate (*),
The review of the quote and / or pieces of information communicated by the supplier,
The supplier’s notoriety or experience (**) and / or,
Samples testing, if judged appropriate.
If the company already worked with the company on other projects, the previous supplier/subcontractor evaluations are considered.
Supplier choice is materialized by the ordering.
(*) The importance of quality insurance as a selective criterion is decided case by case, regarding the supply intended use, its impact on patient or user safety and the possibility to determine its compliance to expectations other than a documentary control. It makes sense that an ISO 13485 certification can be considered as essential for a subcontractor implementing cleaning, assembling and final sealing of the product. Proof of QMS certification should be made to the supplier."
I don't really know what to add here. Do you know specific guidance that could help me? I am also open to any suggestions/thoughts you may have!
Anything in compliance with FDA requirements will be a plus.
Thank you in advance
Mhalik
I am working in a start-up (no product on the market, first product still under development) and we are ISO 13485:2016 certified since early this year. During the certification audit, our auditor made an oral comment regarding our purchasing procedure : our criteria for supplier selection shall be reviewed and improved (we didn't get a deviation but a very insisting oral comment!)
Here is what is currently written in our procedure:
"The supplier is selected according to the following criteria:
The price,
The ability to meet deadlines,
The ability to meet specifications relative to the product / process or service,
The quality insurance, if appropriate (*),
The review of the quote and / or pieces of information communicated by the supplier,
The supplier’s notoriety or experience (**) and / or,
Samples testing, if judged appropriate.
If the company already worked with the company on other projects, the previous supplier/subcontractor evaluations are considered.
Supplier choice is materialized by the ordering.
(*) The importance of quality insurance as a selective criterion is decided case by case, regarding the supply intended use, its impact on patient or user safety and the possibility to determine its compliance to expectations other than a documentary control. It makes sense that an ISO 13485 certification can be considered as essential for a subcontractor implementing cleaning, assembling and final sealing of the product. Proof of QMS certification should be made to the supplier."
I don't really know what to add here. Do you know specific guidance that could help me? I am also open to any suggestions/thoughts you may have!
Anything in compliance with FDA requirements will be a plus.
Thank you in advance
Mhalik