Contract Manufacturing of Medical Device

C

CBAL08

#11
It is about your extension of the quality management system to a place where he does exactly per your specifications. The capability and competency of the supplier to understand and bring to effect all techincal, commercial and regulatory requirements related to the process he is given to execute needs to be assessed. This is first in the evaluation and selection of source and later about monitoring supplies. Technical audits, management system audits, Assessment of infrastructure and maintenance of facilities, HR capability and training of his human resources could be typically considered along with sample evaluation, process capability and validation, and maintenance of records of supplies.
Does this guide you forward ...... ?
good luck
Thank you for the guidance. I have an experience in a manufacturing company before and have been audited , but have never been in the field of Contract manufacturing ( where you need to select the manufacturer for you)and that is why I am looking for guidence and information so that I can be prepared for the task.
As per your guidance it is like auditing the company and monitoring excatly the same was we do for our company.
Is there a paper or articel related by any chance as ISO 13485 or 9001 hardly talks about it .
 
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C

CBAL08

#12
One of the best ways to control the subcontract of the manufacturing of your design is to create a written agreement with your supplier

The agreement would include issues such as:

1. Quality system requirements and notications of changes to the system
2. Right of access
3. Traceability requirements
4. Notification of nonconforming product
5. Changes to processes

As part of your internal audit, you may want to schedule an audit at the supplier on a periodic basis to ensure that they are following the requirements.
Thank you so much for your answer to my questions. Are there any samples that I can see which could make it easier. Or any link where Ic an read more about this.:thanx:
 
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