ABSTRACT

A2LA American Association for Lab Accreditation AABB American Association of Blood Banks ANSI-ASQ American National Standards Institute-American Society for

Quality AOA American Osteopathic Association ASCLD-LAB American Society of Crime Lab Directors/Laboratory

Accreditation Board CAP College of American Pathologists CEN Comité Europeen de Normalisation (European Standards

Organization) CIPM Comité International des Poids et Mesures CLIA Clinical Laboratory Improvement Amendments CLSI Clinical and Laboratory Standard Institute CMS Centers for Medicare and Medical Services COLA Commission on O²ce Laboratory Accreditation CPA Clinical Pathology Accreditation

7.3.3 U.S. Regulations and Accreditation Organizations 175 7.3.3.1 Centers for Medicare and Medicaid Services

Clinical Laboratory Improvement Act (CMS CLIA) 175 7.3.3.2 Commission on O²ce Laboratory Accreditation 177 7.3.3.3 College of American Pathologists (CAP) 178 7.3.3.4 JCIA 187 7.3.3.5 Other U.S. Nonmedical Accreditation

Organizations 190 7.3.4 European Accreditation Organizations 191

7.3.4.1 European Cooperation for Accreditation 191 7.3.4.2 European Standards Organization CEN 192

7.3.5 Accreditation Organizations and Policies in Selected Countries 194 7.3.5.1 Canada 194 7.3.5.2 United Kingdom 194 7.3.5.3 Germany 195 7.3.5.4 Finland 196 7.3.5.5 Italy 196 7.3.5.6 France 196 7.3.5.7 China 197 7.3.5.8 Developing Countries 197

7.4 Publications and Journals on Accreditation 199 References 201

DAP Deutsches Akkreditierungssystem Prüfwesen (German Accreditation System for Testing)

EA European Cooperation for Accreditation EC4 e European Communities Confederation of Clinical

Chemistry and Laboratory Medicine EQA External quality assessment EQALM European Committee for External Quality Assurance

Programmes in Laboratory Medicine FAPAS Food Analysis Performance Assessment Scheme FDA Food and Drug Administration GCLP Good clinical laboratory practice GLP Good laboratory practice HHS U.S. Department of Health and Human Services IAF International Accreditation Forum IAS International Accreditation Service ICSCA Industry cooperation on standards and conformity

assessment IEC e International Electrotechnical Commission IFCC International Federation of Clinical Chemistry and

Laboratory Medicine IFSTP International Federation of Societies of Toxicologist

Pathologists ILAC International Laboratory Accreditation Cooperation ISO International Organization for Standardization JC Joint Commission JCIA Joint Commission International Accreditation L-A-B Laboratory Accreditation Bureau LAP Laboratory Accreditation Program of CAP LIS Laboratory Information System NVLAP National Voluntary Accreditation Program OIML Organisation Internationale de Métrologie Légale PJLABS Perry Johnson Laboratory Accreditation Service PT Prociency testing QM Quality management SOP Standard operation procedure UKAS United Kingdom Accreditation Service UNIDO United Nations Industrial Development Organisation

Accreditation may be dened on several ways. Various dictionaries provide general denitions of accreditation, as

or

According to Merriam-Webster online dictionary “to accredit” means

International Standard Organization, which is involved in issuing accreditation standards, described accreditation as third party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specižc conformity measurement tasks. Conformity assessment body was dened as a body that performs conformity assessment services and that can be the object of accreditation, whereas conformity assessment was the demonstration that specižed requirements relating to a product, process, system, person or body are fulžlled [5].