Quality assurance, accreditation, and certification: needs and possibilities.

Abstract:

:Demonstrable quality of laboratory services entails two parts. First, one needs a quality policy statement, identification of user needs, choice of measurement procedures, reference measurement system to provide traceability, control materials, and proficiency testing with materials having reference-measurement-assigned values. Second, it may be useful to obtain recognition of competence in addition to the director's certificate, such as Good Laboratory Practice (when studying toxicity of chemicals), ISO 9000 certification of a self-defined quality system, nongovernmental professional accreditation, or, most demanding, governmental accreditation according to European Standard EN 45,001 with some modifications. These require external quality audit; ISO and EN also require a quality manual, which is valuable documentation in any case.

journal_name

Clin Chem

journal_title

Clinical chemistry

authors

Dybkaer R

subject

Has Abstract

pub_date

1994-07-01 00:00:00

pages

1416-20

issue

7 Pt 2

eissn

0009-9147

issn

1530-8561

journal_volume

40

pub_type

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