Study sign off question / responsibilities

#1
Looking to set up a small lab. We already have a small unit associated to HLA typing so have the QMS requirements already in place and up and running against 13485. My question is how can we easily assess what the responsibilities are against staff who can sign off virology studies, can this be made by staff with the knowledge and experience to do so or does it need to be a recognised lab or qualified organisation that should sign the studies off. Providing we have all the validation and verification and associated documents to prove the product and its intended use, is there any reason why we cant do this ourselves?
 
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#2
Well, i am not familiar with 13485 but 17025 does let you define who reviews and approves your results, however recognition from an external party depends on your customer's requirements, i would think that for virology studies your customer (be it hospitals, medics or general population) dont rely on testing from a lab that isnt accedited by a proper acceditation body, and this depends on your particular government legal requirements aswell as your particular customer (eg a hospital demanding you are ISO9001 certified or ISO17025 certified)

it is your responsability to research any applicable Legal requirements to operate at your particular location and it sould be clear to you what your customer expects from you as a lab

hope this helps
 

Watchcat

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#3
Not sure why you posted this question to a subforum specifically dedicated to a ISO 17025, but I suggest you try posting it in the medical device subforum dedicated to ISO 13485.
 
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