TAG:
iso 9001 certification
Much Disruption for Labs In 2016’s Top 10 Stories
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…
First-Mover Labs Reveal Success with Lean & QMS
CEO SUMMARY: There is good news for those clinical labs and pathology groups currently operating robust Lean, Six Sigma, and process improvement programs. The Institute of Medicine’s new report calls for all healthcare providers to rapidly transform themselves into ‘continuously learn…
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…
New Clinical Lab Trends To Shape Events in 2010
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
DNV Offers Accreditation For Both CMS and ISO
CEO SUMMARY: For about a year, hospitals and health systems have had a new choice for meeting the Medicare Conditions of Participation. This new choice is Det Norske Veritas (DNV). Because DNV offers a dual process for achieving Medicare accreditation and ISO 9001 certification, it brings…
Are Pathologists The Next “Fish In The Barrel?”
“SHOOTING FISH IN THE BARREL” MAY BE A GOOD METAPHOR TO DESCRIBE what can soon happen to the profession of pathology. This issue of THE DARK REPORT covers several important stories on laboratory management, with direct consequences to pathologists. First, the ISO 9001 certification of the …
Nichols Institute Earns ISO 9001 Certification
CEO SUMMARY: Although it’s the first ISO 9001-certified clinical laboratory in North America, Quest Diagnostics’ Nichols Institute is a late-comer to the party. Most major diagnostics companies already have ISO 9001 certification. This issue of THE DARK REPORT explores why Nichols’ …
Expect ISO 9000 To Alter Clinical Lab Management
CEO SUMMARY: Perceptive laboratory executives and pathologists should welcome the impending arrival of ISO 9000 into the clinical laboratory industry. It promises to solve many problems of laboratory management. The diagnostics industry, responsible for manufacturing instruments and suppl…
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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