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meddevicesandiego

Guest
#1
I am looking for an SOP template for conducting quarterly dose audits based on ISO 11137. We are a manufacturer for medical devices that uses an external sterilization house and test lab. If anyone has one they using and willing to share, that would be helpful rather then trying to reinvent the wheel. Thanks in advance!
 

Jen Kirley

Quality and Auditing Expert
Staff member
Administrator
#2
Re: Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 1

Do we have anything for meddevicesandiego?
 

Ajit Basrur

Administrator
Staff member
Administrator
#3
Re: Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 1

I am looking for an SOP template for conducting quarterly dose audits based on ISO 11137. We are a manufacturer for medical devices that uses an external sterilization house and test lab. If anyone has one they using and willing to share, that would be helpful rather then trying to reinvent the wheel. Thanks in advance!
Welcome to the Cove :bigwave:

Do you want the SOP or the SOP template ?
 
M

meddevicesandiego

Guest
#4
Re: Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 1

Sorry about the confusion...I am looking for an SOP that covers radiation dose audits.

Thanks
 

csterling

Involved In Discussions
#5
Re: Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 1

Hi Meddevicesandiego;

Did you ever get the SOP?
Would you share it?
 
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