The Cove Business Standards Discussion Forums
Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 11137
Please read this thread...
Software update
Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 11137
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 11137

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
audits and auditing, gamma irradiation sterilization, iso 11137 - medical device radiation sterilization, subcontracted goods processes and services, forms and templates (general), procedures (general), medical devices
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 7th May 2009, 02:16 PM
meddevicesandiego

 
 
Total Posts: 2
Please Help! Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 11137

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!

Sponsored Links
  Post Number #2  
Old 8th May 2009, 06:11 AM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,143
Re: Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 1

Do we have anything for meddevicesandiego?
  Post Number #3  
Old 8th May 2009, 11:36 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,213
Re: Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 1

Quote:
In Reply to Parent Post by meddevicesandiego View Post

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

Do you want the SOP or the SOP template ?
  Post Number #4  
Old 8th May 2009, 12:35 PM
meddevicesandiego

 
 
Total Posts: 2
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
  Post Number #5  
Old 21st April 2010, 10:17 AM
csterling

 
 
Total Posts: 39
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?
  Post Number #6  
Old 21st April 2010, 04:39 PM
ontheopenroad's Avatar
ontheopenroad

 
 
Total Posts: 29
Re: Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 1

Here is my procedure, which I have never had any problem with from external auditors.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf QSP-038-01 Validation and Monitoring of Gamma Sterilization.pdf (72.9 KB, 462 views)
Thank You to ontheopenroad for your informative Post and/or Attachment!
  Post Number #7  
Old 22nd April 2010, 01:45 AM
yana prus's Avatar
yana prus

 
 
Total Posts: 147
Re: Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 1

thanks for sharing!
  Post Number #8  
Old 23rd April 2010, 12:48 PM
csterling

 
 
Total Posts: 39
Re: Radiation (Gamma or E-beam) Dose Audit SOP - Quarterly dose audits based on ISO 1

Thanks for your help.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Quarterly Dose Verification for e-beam Sterilization Question pbell0000 ISO 13485:2016 - Medical Device Quality Management Systems 1 12th February 2013 09:30 PM
Gamma Validation vs. Quarterly Dose Audit Differences Nash27 ISO 13485:2016 - Medical Device Quality Management Systems 3 29th January 2013 06:20 PM
Gamma Ray Sterilization Quarterly Dose Auditing Supplier Requirements Ktrna ISO 13485:2016 - Medical Device Quality Management Systems 5 8th February 2012 11:09 AM
ISO 11137 gamma sterilized device dose audit - Lead time? engineer0129 Other ISO and International Standards and European Regulations 7 13th October 2010 09:29 AM
Quarterly Gamma Dose Audit Question IntegrityandQuality Other Medical Device Related Standards 4 27th August 2010 10:06 AM



The time now is 11:20 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"