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
Quality management system and effects analysis (FMEA). (ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements). The Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award. The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers;