The AS9100 Quality Management System (QMS) standard anticipated that organizations would make customer satisfaction and continual improvement cornerstones of their business strategy. Elements of the standard implicitly supported this. However, some organizations achieved certification without integrating the QMS into the business, and it had no measurably positive impact on the quality of their products or services.<\/p>\n
Well, industry has taken action. The release of AS9100 Rev D<\/a> clearly insists that organizations implement a QMS woven into the fabric of their business systems. This article describes a few of the most visible requirements that make this apparent.<\/p>\n One of the principles of change management is that for an idea to move from the abstract to everyday practice, top management commitment must be open and active. The late Philip Crosby, a well-known quality guru, developed 14 steps of quality improvement. The first of these is management commitment. Likewise, the AS9100 standard begins with the following requirements of an organization\u2019s top management:<\/p>\n 1) Section 4 Context of the Organization<\/a><\/strong>\u00a0\u2013 This new term in the lexicon of the QMS consists of the four clauses listed below.\u00a0 A summary of the wording from AS9100 that integrates the QMS with the business systems is in bold.<\/p>\n Table 1 – Context of the Organization<\/em><\/p>\nAS9100D requirements related to business systems<\/h2>\n
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\n \nClause<\/td>\n Summary<\/td>\n<\/tr>\n<\/thead>\n \n 4.1 Understanding the Organization and Its Context<\/em><\/td>\n Determine the issues relevant to the organization\u2019s purpose and strategic direction and affecting its ability to achieve the intended results of the QMS.<\/strong><\/td>\n<\/tr>\n \n 4.2 Understanding the Needs and Expectations of Interested Parties<\/em><\/td>\n Determine the effect the interests of other parties (e.g., customers, regulatory agencies, employees, stockholders, competitors) may have on the organization\u2019s ability to meet customer, statutory, and regulatory requirements.<\/strong><\/td>\n<\/tr>\n \n 4.3 Determining the Scope of the Quality Management System<\/em><\/td>\n Determine the boundaries of the QMS that apply to external and internal issues in 4.1 above.<\/strong><\/td>\n<\/tr>\n \n 4.4 Quality Management System and Its Processes<\/em><\/td>\n Determine the processes and interactions required to adequately address customer, statutory, and regulatory requirements.<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n