P
paulervin2
Do any of you know where I might find conformance statistics for ISO 15189? For EU countries, Asia, US? Having a hard time finding anything online.
Michael Malis
Quite Involved in Discussions
Paulervin2,
ISO 15189:2012 is the current standard for Medical Laboratories. it is outlined requirements for Quality and Competence for Labs. if you are in the Lab, you need to comply to this standard. This is very similar to ISO 13485 for medical devices.
If the lab is providing test results to the doctors, than the Training, Competency and Proficiency of the Staff is important because accuracy and security of information is very important. While Management Responsibility is similar to other standards, the Laboratory Cycle (process) is completely different. Also, laboratory premisses must be maintain. Over 70 accreditation bodies have signed recognition agreement called
the ILAC Arrangement (www.ilac.org). Please see website for the latest information and statistics.
Regards,
Mike
ISO 15189:2012 is the current standard for Medical Laboratories. it is outlined requirements for Quality and Competence for Labs. if you are in the Lab, you need to comply to this standard. This is very similar to ISO 13485 for medical devices.
If the lab is providing test results to the doctors, than the Training, Competency and Proficiency of the Staff is important because accuracy and security of information is very important. While Management Responsibility is similar to other standards, the Laboratory Cycle (process) is completely different. Also, laboratory premisses must be maintain. Over 70 accreditation bodies have signed recognition agreement called
the ILAC Arrangement (www.ilac.org). Please see website for the latest information and statistics.
Regards,
Mike