Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...

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Quality System Essentials � 1997 AABB introduces 10 QSEs � Requires implementation of a quality program � Intent of a quality program is to ensure quality principles are consistently throughout operations � Changes the approach of quality from one of detection g pp q y to one of prevention
AABB now � Quality system requirements are imbedded in standards � Organization � Resources � EEquipment i � Supplier and Customer Issues � Process Control �� Documents and Records � Deviations, Nonconformances, and Adverse Events � Assessments: Internal and External � Process Improvement Through Corrective and Preventive Action � Facilities and Safety � Accreditation program is based on ISO/IEC Guide 58:1993 and ANSI/ISO/<strong>ASQ</strong>C Q QQ10013‐1995 3 995
Page 1 and 2: Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQ
Page 3 and 4: A Horse named Jim � In 1901 a ser
Page 5 and 6: Early Regulations ‐ 1903 � Issu
Page 7 and 8: World at War � American Red Cross
Page 9 and 10: Court Cases 1960‐1970 � Violati
Page 11 and 12: National Blood Policy � 1972 Pres
Page 13 and 14: Bureau of Biologics Regulation �
Page 15 and 16: HIV and the Blood Supply � 1980
Page 18 and 19: FDA Guideline � Intended to be us
Page 20 and 21: Quality Control � Several dimensi
Page 24 and 25: AABB Accreditation � 1998 AABB In
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Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...

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