Quality Systems for Non-routine and R&D Analytical Work - Accreditation of Non-routine Laboratories

These days many testing laboratories are familiar with formal QM-Systems like EN 45001 (ISO Guide 25), ISO 900X (EN 29000 ff) or GLP.Laboratories engaged in R&D face several QM-systems which are suitable to deal with Non-Routine and R&D analytical work. To make the appropriate choice it is however necessary that the laboratories know the application fields, scopes, benefits and drawbacks of the various systems. Hence this presentation tries to give both survey and insight into the QM-systems concerned like EN 45001, ISO 9001 and GLP as well as the new ISO 17 025. The pros and cons for more or less harmonization of the various standards will also be discussed.While from the beginning ISO 9001 and GLP allowed more or less efficiently to deal with Non-Routine and R&D the accreditation scheme according to EN 45001 has become flexible enough not until a few years ago. By using the type of test approach to define the scope several accreditation bodies developed a very promising way, which has since then been increasingly practised successfully, e.g. in Switzerland or Germany.As for laboratories seeking third party recognition of their technical competence accreditation looks more appropriate than the other systems this lecture also addresses some aspects of the accreditation of Non-Routine analysis. Based on own experience the author will give some practical hints on how to prepare a multidisciplinary Non-Routine laboratory according to the type of test approach.