ISO 9000 compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system. "ISO 9001:2000" replaced all three former standards of 1994 issue, "ISO 9001", "ISO 9002" and "ISO 9003". Design and development procedures were required only if a company does, in fact, engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing front and
ISO 15189 section on laboratory information management. ISO 15189 ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 "General requirements for the competence of testing and calibration laboratories". This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test