the cap inspection and accreditation program at age 50 - American ...
the cap inspection and accreditation program at age 50 - American ...
the cap inspection and accreditation program at age 50 - American ...
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Every number is a life.Every number is a life.ISO 15189:2007Medical labor<strong>at</strong>ories – Particular requirements forquality <strong>and</strong> competenceWritten by Work Group 1 of TC 212Every number is a life.A long, arduous gest<strong>at</strong>ion• Originally proposed in final form in 1999• Challenged by TC 176, Quality Man<strong>age</strong>ment <strong>and</strong>Quality Assurance• Question of overlap with ISO 17025, GeneralRequirements for <strong>the</strong> Competence of Testing <strong>and</strong>Calibr<strong>at</strong>ion Labor<strong>at</strong>ories©2008 College of <strong>American</strong> P<strong>at</strong>hologists. All rights reserved.Every number is a life.ISO Evolution of Quality Man<strong>age</strong>ment St<strong>and</strong>ardsRel<strong>at</strong>ionship of ISO 9001 to ISO I5189IndustryQMS Certific<strong>at</strong>ionISO TC 176ISO CascoCalibr<strong>at</strong>ionLabor<strong>at</strong>oryISO TC 212ClinicalLabor<strong>at</strong>oryAccredit<strong>at</strong>ionMedicalLabor<strong>at</strong>ories-ParticularrequirementsFor quality <strong>and</strong>competence.9001• Best fits generic client/ providerarrangements• Example:Manufacturingindustry15189• Designed specificallyfor clinical <strong>and</strong> medicallabor<strong>at</strong>ories• Developed throughintern<strong>at</strong>ionalconsensus amongclinical <strong>and</strong> medicalexpertsAccredit<strong>at</strong>ion<strong>and</strong> Calibr<strong>at</strong>ionLabor<strong>at</strong>oriesTesting©2008 College of <strong>American</strong> P<strong>at</strong>hologists. All rights reserved.Every number is a life.©2008 College of <strong>American</strong> P<strong>at</strong>hologists. All rights reserved.Every number is a life.8
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