Libeer J C
Scientific Institute of Public Health, Clinical Pathology Department, Brussels, Belgium.
Scand J Clin Lab Invest. 1999 Nov;59(7):575-8. doi: 10.1080/00365519950185382.
In the future, there will be a universal standard for quality management in medical laboratories: ISO 15189. This standard follows the basic principles of ISO 17025, the general standard for test laboratories, but also adds several specific aspects. A comparison between these standards is given. The language of ISO 15189 is designed to be understood by medical laboratory professionals. As this standard is applicable to all medical laboratory fields, requirements are given in general terms requiring the laboratory to implement them correctly. Because it is essential that information provided by laboratory results is useful for healthcare, the requirements covered by ISO 15189 are compared with those needed for providing good medical laboratory services. The capabilities of the personnel at the laboratory clinic interface are the most difficult to assess and evaluate in an adequate quality management system.
未来，医学实验室质量管理将有一个通用标准：ISO 15189。该标准遵循测试实验室通用标准ISO 17025的基本原则，但也增加了几个特定方面。给出了这些标准之间的比较。ISO 15189的语言旨在供医学实验室专业人员理解。由于该标准适用于所有医学实验室领域，因此以一般术语给出了要求，要求实验室正确实施。因为实验室结果提供的信息对医疗保健至关重要，所以将ISO 15189涵盖的要求与提供优质医学实验室服务所需的要求进行了比较。在适当的质量管理体系中，实验室临床接口人员的能力是最难评估的。
