ACCREDITATION OR GLP - QUALITY MANAGEMENT IN ANALYSIS AND COUNSELING

GLP and EN 45001 are internationally recognized quality guidelines and standards for analytical laboratories. The guidelines of the GLP have been existing since the end of the 70ths in the U.S.A. and with the e arly 80ths in Europe and Japan. Several quality oriented laboratories are GLP certified; GLP studies are recognized in the whole world. Accr editation or to conform GLP? GLP is restricted to an defined area. Oth erwise, one free translation of GLP is 'Giant lot of Papers'. The effo rts for GLP are expensive; most customers are not willing to pay for i t unless GLP studies are forced by law. The new European Standard EN 4 5001 offers a more suitable, less paper expensive and more content ori ented quality standard for any kind of physical, technical are analyti cal kinds of tests. For example, the EN 45001 is widely accepted by th e European food manufacturers. Differences between GLP and EN 45001 Ac cording to its individual approach, GLP and EN set up different claims to their user. GLP requires a perfect documentation of every step of a study to guarantee a person independent reproducibility. GLP is a fo rmal quality assurance system. EN requires and proofs the presence of a formal QS-System and the technical or scientific skill of the labora tory staff. The EN has been drawn up with the objective of promoting c onfidence in those laboratories which conform to it.