Hi, I'm using all useful information on this site for few years and this is my first time posting. 
I work with small organizations for development of QMS and also auditing to ISO 9001 & ISO 13485 requirements.
I need your guidance for development of validation procedure for precision machining processes. I found lots of good informations on various threads but my question is how can we apply validation requirement to the process which produce mostly prototype in small quantities? This is toward implementation of ISO 13485 in a precision machining company (Contracted manufacturer of medical devices). We are able to perform IQ but i'm still not very clear how to take the process further for OQ & PQ.
Also, for contracted manufacture as they do not perform design of the medical device what should include our Device Master Records?
Thank you,
Sarah54

I work with small organizations for development of QMS and also auditing to ISO 9001 & ISO 13485 requirements.
I need your guidance for development of validation procedure for precision machining processes. I found lots of good informations on various threads but my question is how can we apply validation requirement to the process which produce mostly prototype in small quantities? This is toward implementation of ISO 13485 in a precision machining company (Contracted manufacturer of medical devices). We are able to perform IQ but i'm still not very clear how to take the process further for OQ & PQ.
Also, for contracted manufacture as they do not perform design of the medical device what should include our Device Master Records?
Thank you,
Sarah54