ISO 9000 model ideally suited for quality plan at blood centers

Transfusion

Volumn 38, Issue 1, 1998, Pages 79-85

  Kalmin, N D ^a   Myers, L K ^a   Fisk, M B ^a  

^a South Texas Blood and Tissue Center   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BLOOD ANALYSIS; BLOOD BANK; GOOD MANUFACTURING PRACTICE; INTERPERSONAL COMMUNICATION; QUALITY CONTROL; STATISTICAL ANALYSIS; TRAINING;

EID: 0031937060     PISSN: 00411132     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1537-2995.1998.38198141503.x     Document Type: Article

References (12)

1. South Texas Blood and Tissue receives ISO accreditation. AABB Wkly Rep 1996;2(Dec 13):4.
2. American National Standard. ANSI/ASQC Q9000 Series Standards-1994. Quality management and quality assurance standards - guidelines for selection and use. Milwaukee, WI: American Society for Quality Control, 1994.
3. Quality assurance guidelines for blood establishments. Bethesda, MD: Center for Biologics Evaluation and Research, 1992.
4. Quality program. Bethesda: American Association of Blood Banks, 1994.
5. ISO standards compendium - ISO 9000 quality management. 6th ed. Geneva, Switzerland: International Organization for Standardization, 1996.
6. 21 CFR 200-299 and 600-799 (1996).
7. 42 CFR part 405 et seq (1995).
8. 29 CFR parts 1910, 1915, 1917, 1918, 1926, 1928, hazard communication; final rule (1996).
9. Callery MF, Nevalainen DE, Kirst TM. Quality systems and total process control in blood banking. Transfusion 1994;34:899-906.
10. Zuck TF. Current good manufacturing practices. Transfusion 1995;35:955-66.
11. Nevalainen DE, Lloyd HL. ISO 9000 quality standards: a model for blood banking? Transfusion 1995;35:521-4.
12. Cost of quality utility, version 3.0. Orlando, FL: The Harrington Group, September 1995.