Iso 15189
This standard was approved by ISO TC212 in February 2003. It is not widely known or accepted in the US, since medical laboratories are regulated by CAP and FDA. However, it is has been widely accepted in Canada, Europe, and Asia. The purpose of this standard is to provide uniformity and the operations of a clinical laboratory, whether it is for humans or animals. Like any other standard, requires management commitment, and dedicated personnel. It takes about a year for implementation, and the end result is a very well managed, organized, and standardized laboratory. Looks like that this standard is going to become part of CAP checklists, so eventually it will be implemented in US labs. If anyone needs anything specific please email me. ISO 17025 for measurement and calibration labs is not suitable for medical laboratories, and ISO 15189 was developed based on ISO 9000, ISO 17025, FDA GMP's, and certain European standards not related to any ISO form.Please feel free to share any experiences you have with this standard.
Thanks.
Al K. Doris MBA,MT(ASCP)SC