managing R&D, ISO 9001:2000

by Christoph Gassner

Research and Development (R&D) has been audited internally according to ISO 9001:2000 for the first time in June 2005. This process has a defined structure and is reasoned by its results: applicable innovation to sustain core competency in the field of “blood and its products” – in the broadest sense, e.g. including diagnosis. It makes sense to think about the meaning of the words INNOVATION and CORE COMPETENCY and their relationship. CORE COMPETENCY with respect to a certain “product” is only in place if the “product” is of VALUE, RARE, NOT IMITABLE and NOT REPLACEABLE. INNOVATION MUST be used to obtain and sustain these attributes.

Accepting this theoretical background, R&D must now be interpreted as process to deliver innovation and needs to be managed accordingly. As a matter of course, INPUT into the process decides the result and therefore, needs thoughtful attention. The actual RESEARCH part itself bears partially creative components, difficult to be organized in standard operation procedures. Finally, the OUTPUT is publically available knowledge, which may serve as module for a more elaborated theoretical modell, or can easily be displayed as a “better product”.