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Hospital Laboratory wants to apply ISO 9001


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Some Related Topic Tags (Not all threads are Tagged)
hospital laboratories, hospitals, implementing iso 9001, iso 9001 - quality management systems, implementation of a standard in a company, laboratories (general)
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  Post Number #1  
Old 24th March 2011, 11:16 AM
jasminphyu

 
 
Total Posts: 29
BIG Smile Hospital Laboratory wants to apply ISO 9001

Dear Members,

Please kindly advice me if one of the Hospital Laboratory want to apply ISO 9001:2008 Certificate, what major process need to implement and do they need to do Proficiency test (PT) and Inter-laboratory test? or what they need more in QMS.

Thank for your help.

Jasminphyu

Last edited by jasminphyu; 24th March 2011 at 11:34 AM. Reason: PT = Proficiency Test

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  Post Number #2  
Old 25th March 2011, 12:36 AM
harry

 
 
Total Posts: 6,287
Re: Hospital Laboratory wants to apply ISO 9001

Wouldn't Wikipedia reference-linkISO 15189 be more appropriate for a Wikipedia reference-linkMedical laboratory?

Quote:
While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.
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  Post Number #3  
Old 25th March 2011, 03:36 AM
jasminphyu

 
 
Total Posts: 29
Re: Hospital Laboratory wants to apply ISO 9001

Dear Harry,

Thank you for your advice.

I'm still confused, I found one member replied to other member previous post, that ISO 15189 is especially for "Medical Device Manufacturing company". For Laboratory it should be ISO 9001. But that company don't want to apply ISO 17025 yet.

Please help me to understand for choosing.

Best regards,

Jasminphyu

Last edited by Stijloor; 25th March 2011 at 06:43 AM. Reason: Typos.
  Post Number #4  
Old 25th March 2011, 07:58 PM
harry

 
 
Total Posts: 6,287
Re: Hospital Laboratory wants to apply ISO 9001

Quote:
In Reply to Parent Post by jasminphyu View Post

...................... I'm still confused, I found one member replied to other member previous post, that ISO 15189 is especially for "Medical Device Manufacturing company". For Laboratory it should be ISO 9001. ......................
This is not correct. Users here have to be aware that not everything posted here is correct. Read through all the post and make your own judgment - the odd ones especially. Do some simple research to confirm if you need to.

From the ISO (authority) website:

Quote:
ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories.

ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
Thanks to harry for your informative Post and/or Attachment!
  Post Number #5  
Old 27th March 2011, 10:34 PM
srinisan133

 
 
Total Posts: 3
Re: Hospital Laboratory wants to apply ISO 9001

Hi,
ISO 9001 is for the overall QMS for the organization/department where you want to implement quality system. ISO 15189 is specially for the Medical Laboratories where you can implement this standard and it is not for "Medical device manufacturing". ISO 17025 is for all other laboratories except for the Medical labs.
You can either go for ISO 9001 or ISO 15189, but my suggestion would be to go for 15189.
You can reach me at XXXXXXXXXXXX for further clarifications.

R. Srinivasan

Moderator Note:
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Last edited by harry; 28th March 2011 at 12:02 AM. Reason: Add moderator note
  Post Number #6  
Old 28th March 2011, 08:37 AM
J0anne

 
 
Total Posts: 437
Re: Hospital Laboratory wants to apply ISO 9001

Quote:
In Reply to Parent Post by jasminphyu View Post

Dear Members,

Please kindly advice me if one of the Hospital Laboratory want to apply ISO 9001:2008 Certificate, what major process need to implement and do they need to do Proficiency test (PT) and Inter-laboratory test? or what they need more in QMS.

Thank for your help.

Jasminphyu
What are you processing and what's your location?
  Post Number #7  
Old 30th March 2011, 08:10 AM
jasminphyu

 
 
Total Posts: 29
Re: Hospital Laboratory wants to apply ISO 9001

Dear Srinisan,

Thank you for your advice.

Regards,
Jasminphyu
  Post Number #8  
Old 30th March 2011, 09:10 AM
jasminphyu

 
 
Total Posts: 29
Re: Hospital Laboratory wants to apply ISO 9001

Dear Joanne,

Process is "Public Hospital Laboratory" in Myanmar.

Thanks,
Reply

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