ISO 9000 risks include how much certification will cost, increased bureaucratic processes and risk of poor company image if the certification process fails. According to John Seddon, ISO 9001 promotes specification, control, and procedures rather than understanding and improvement. Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, ... [undermining] the need for an organization to set its own quality standards". In short, Wade argues that reliance on the specifications of ISO 9001 does not guarantee a successful quality system. The standard is
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;