M
MEDQA
Hello to all,
I'm trying to revise our Evaluation of Sub Contractor procedure and the Approved Supplier List for a small ISO 13485 certified company (under 15 people). I found lots of useful info on the subject but am still concerned about my interpretation of what is needed.
The person previously responsible stated that every vendor needs to be referenced on the list.
I would like to exclude general suppliers (defined below) from the documented evaluation process used for Key suppliers affecting product quality. I also question the need to have general suppliers on the Approved list, however I can see a benefit.
The selection, evaluation & monitored performance of general suppliers seems like a reasonable purchasing responsiblity that if needed may include input from other departments but should not need evaluation documentation.
Am I missing something or does this actually make sense? - Thank you.
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General Suppliers: Suppliers not affecting product quality which include Office supplies, general factory supplies – tools, safety glasses, janitorial services / supplies, repair parts, etc. from OEM’s of EMS production machinery in use.
Note: We have a clean room and might need to make an exception to include clean room supplies under Key Suppliers?
[FONT="][/FONT]General Suppliers are selected on their anticipated ability to meet price and delivery objectives and
I'm trying to revise our Evaluation of Sub Contractor procedure and the Approved Supplier List for a small ISO 13485 certified company (under 15 people). I found lots of useful info on the subject but am still concerned about my interpretation of what is needed.
The person previously responsible stated that every vendor needs to be referenced on the list.
I would like to exclude general suppliers (defined below) from the documented evaluation process used for Key suppliers affecting product quality. I also question the need to have general suppliers on the Approved list, however I can see a benefit.
The selection, evaluation & monitored performance of general suppliers seems like a reasonable purchasing responsiblity that if needed may include input from other departments but should not need evaluation documentation.
Am I missing something or does this actually make sense? - Thank you.
[FONT="][/FONT]
General Suppliers: Suppliers not affecting product quality which include Office supplies, general factory supplies – tools, safety glasses, janitorial services / supplies, repair parts, etc. from OEM’s of EMS production machinery in use.
Note: We have a clean room and might need to make an exception to include clean room supplies under Key Suppliers?
[FONT="][/FONT]General Suppliers are selected on their anticipated ability to meet price and delivery objectives and