ISO 9000 account. The standard no longer specifies that the organization shall issue and maintain documented procedures, however, ISO 9001:2015 requires the organization to document any other procedures required for its effective operation. The standard also requires the organization to issue and communicate a documented quality policy, a quality management system scope, and quality objectives. The standard no longer requires compliant organizations to issue a formal Quality Manual. The standard does require retention of numerous records, as specified throughout the standard. New for the 2015 release is a requirement for an organization to assess risks and opportunities (section 6.1) and to determine
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;