TAG:
international accreditation
October 13, 2014 “Intelligence: Late-Breaking Lab News”
Quality management systems (QMS) have made inroads in some of the organizations that accredit clinical laboratories in the United States to the requirements of CLIA. Last month, COLA of Columbia, Maryland, acknowledged that it had recertified to the standards of ISO 9001: 2008. The r…
May 28, 2013 “Intelligence: Late Breaking Lab News””
Globalization of laboratory medicine continues to move forward. Two recent examples illustrate this trend. Earlier this month, the University of Pittsburgh Medical Center (UPMC) announced that it had entered into an agreement with the Citizens Hospital of Hyderabad, …
ISO 15189 Accreditation Earned by Spectra Labs
CEO SUMMARY: Spectra Laboratories Inc., recently announced that it had earned accreditation to the ISO 15189:2007 standard, following an assessment by a team from the Association for Laboratory Accreditation (A2LA). Spectra is a high-volume laboratory that serves renal patients. …
ISO 15189 Accreditation Requires Specific Steps For Global Recognition
CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical…
Explaining Certification Versus Accreditation
CEO SUMMARY: Early signs are that the quality management systems (QMS) most likely to find favor with hospitals and clinical laboratories in the United States will be those that meet standards developed by the International Organization for Standardization (ISO). Many hospitals and clinic…
ISO 15189 Gains Favor For Lab Accreditation
CEO SUMMARY: Volunteers for the Clinical and Laboratory Standards Institute (CLSI) are in the midst of an 18-month project to help five …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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