Hospital Laboratory wants to apply ISO 9001

jasminphyu

Involved In Discussions
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
 
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harry

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

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.
 

jasminphyu

Involved In Discussions
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
 
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harry

Trusted Information Resource
...................... 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:

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.
 
S

srinisan133

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:
1. The proper place for private contacts is your profile page.
2. Please refer to our TOS (Terms of Service) - Elsmar Cove Forum Registration and Use TOS
 
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J0anne

Joanne
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?
 

Raffy

Quite Involved in Discussions
Hi Harry,
Thank you very much for the information on ISO15189. This is another eye opener for me since the only information I've got is for ISO17025.
Thanks again.
Best regards,
Raffy
 

Richard Regalado

Trusted Information Resource
Hi Harry,
Thank you very much for the information on ISO15189. This is another eye opener for me since the only information I've got is for ISO17025.
Thanks again.
Best regards,
Raffy

ISO 15189 was launched in the Philippines way back 2003. The first organization certified to it is Hi-Precision Diagnostic Laboratories. The ISO 15189 certificate is not included in their website "wall of fame" (https://www.hi-precision.com.ph/certificate.do). They must have discontinued the certification. At any rate I was part of the consulting team who implemented the LIMS (laboratory information management system) thereat.
 
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