Quality Management Systems - Requirements for Aviation, Space and Defense Organizations | |
First published | 1999[1] |
---|---|
Latest version | Revision D 2016 |
Organization | Society of Automotive Engineers |
Base standards | ISO 9001 |
Domain | Aerospace Industry |
Website | www |
Aero Space 9100 (AS 9100) is an international standard for aerospace management systems that is a widely adopted and standardized quality management system for the aerospace sector. It was released in 1999 by Society of Automotive Engineers. [1] [2]
AS 9100 replaces the earlier AS 9000 and fully incorporates the entirety of the current version of ISO 9001, while adding requirements relating to quality and safety. Major aerospace manufacturers and suppliers worldwide require compliance with AS 9100 as a condition of doing business with them. [3] [4]
Prior to development of AS 9100 standards for Quality Management Systems, the U.S. military applied two specifications to supplier quality and inspection programs, respectively, MIL-Q-9858A [5] Quality Program Requirements, and MIL-I-45208A Military Specification: Inspection System Requirements. [6] For years these specifications had represented the basic tenets of the aerospace industry. However, when the U.S. government adopted ISO 9001, it withdrew those two quality standards. Large aerospace companies then began requiring their suppliers to develop quality programs based on ISO 9001. [7]
As aerospace suppliers soon found that ISO 9001 (1994) did not address the specific requirements of their customers, including the DoD, NASA, FAA, and commercial aerospace companies including Boeing, Lockheed Martin, Northrop Grumman, GE Aircraft Engines and Pratt & Whitney, they developed AS 9000, based on ISO 9001, to provide a specific quality management standard for the aerospace industry. [8]
Prior to the adoption of an aerospace specific quality standard, various corporations typically used ISO 9001 and their own complementary quality documentation/requirements, such as Boeing's D1-9000 or the automotive Q standard. This created a patchwork of competing requirements that were difficult to enforce and/or comply with. The major American aerospace manufacturers collaborated to develop a unified quality standard based on ISO 9001:1994, which led to the creation of AS 9000. Following its release, companies like Boeing discontinued their previous quality supplements in favor of complying with AS 9000.
Although AS 9000 satisfied immediate needs, it was recognized that OEMs operate globally—a trend that would only increase, so a global standard was needed. The new standardized document, called 9100, was still based on ISO 9001:1994(E), although it was published separately by each country's aerospace association or standards body (AS 9100 in the U.S). AS 9100 added 55 aerospace industry specific amplifications and requirements to ISO 9001:1994. [9]
During the rewrite of ISO 9001 for the year 2000 release, the AS group worked closely with the ISO organization. As the year 2000 revision of ISO 9001 incorporated major organizational and philosophical changes, AS 9000 underwent a rewrite as well. It was released as AS 9100 to the international aerospace industry at the same time as the new version of ISO 9001.
AS 9100A was actually two standards referenced in one publication: Section 1 defines an updated QMS model aligned with the updated ISO 9001:2000 publication while Section 2 defines a legacy model aligned with ISO 9001:1994. Organizations that in the year 2001 were operating a QMS based on ISO 9001:1994 were permitted to conform to Section 2 with the expectation that they would then transition their QMS to Section 1. [10] [11]
As the period for transition from the 1994 to 2000 standards passed, AS 9100B was released in 2004 as an administrative revision to delete Section 2 of the Revision A standard. [11]
The update of AS 9100 from revision B to C is largely to address the following question: “Our supplier is repeatedly late on delivery and failing to meet our requirements, how is it possible that they still have their AS 9100 certificate?” That is, the AS 9100C changes are driven by repeated delivery of non-conforming product and repeated late delivery by organizations that held AS 9100A/B certifications. Those organizations had documented controls that conformed to the standard, however, there were insufficient processes in place to assure effectiveness of those controls. The response in this AS 9100 revision is to elevate the requirements for Risk Management and to make Risk Management an integrated theme throughout the standard. [12]
A major challenge to AS 9100B-compliant organizations was the new AS 9100 auditing standards defined in AS 9101 Revision D, which eliminates the clause-based compliance checklist and requires organizations to provide evidence of effectiveness of their systems and processes. [13]
Summary of Changes between AS 9100B and AS 9100C: [12]
AS 9100 Revision C was released in January, 2009, [14] with considerable delay in application of the new version in audits, largely due to the delay in the release of AS 9101 Revision D and auditor training to the increased auditing rigor of that update. [15]
The update of AS 9100 from revision C to D includes the full text of ISO 9001:2015. In addition to aligning the structure of the aviation, space and defense requirements to the new structure of ISO 9001:2015, the following key changes were implemented: [16]
AS 9100 Revision D was released in September 20, 2016 [17] with a certificate transition period aligned with the ISO 9001:2015 transition. [16] [18]
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration.
The ISO 9000 family is a set of international standards for quality management systems. It was developed in March 1987 by International Organization for Standardization. The goal of it is help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. The ISO refers to the set of standards as a "family", bringing together the standard for quality management systems and a set of "supporting standards", and their presentation as a family facilitates their integrated application within an organisation. ISO 9000 deals with the fundamentals and vocabulary of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. A companion document, ISO/TS 9002, provides guidelines for the application of ISO 9001. ISO 9004 gives guidance on achieving sustained organizational success.
The ISO 14000 family is a set of international standards for environment management systems. It was developed in March 1996 by International Organization for Standardization. The goal of it is help organizations (a) minimize how their operations negatively affect the environment ; (b) comply with applicable laws, regulations, and other environmentally oriented requirements; and (c) continually improve in the above.
A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. These objectives cover many aspects of the organization's operations. For instance, an environmental management system enables organizations to improve their environmental performance, and an occupational safety and health management system enables an organization to control its occupational health and safety risks.
ISO/IEC/IEEE 12207Systems and software engineering – Software life cycle processes is an international standard for software lifecycle processes. First introduced in 1995, it aims to be a primary standard that defines all the processes required for developing and maintaining software systems, including the outcomes and/or activities of each process.
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control, and quality improvement. Quality management is focused both on product and service quality and the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function.
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard, ISO 9001.
ISO/IEC 20000 is the international standard for IT service management. It was developed in 2005 by ISO/IEC JTC1/SC7 and revised in 2011 and 2018. It was originally based on the earlier BS 15000 that was developed by BSI Group.
The ISO/IEC 15288Systems and software engineering — System life cycle processes is a technical standard in systems engineering which covers processes and lifecycle stages, developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Planning for the ISO/IEC 15288:2002(E) standard started in 1994 when the need for a common systems engineering process framework was recognized.
International Automotive Task Force 16949 is an international standard for automotive management systems that is a widely adopted and standardized quality management system for the automotive sector. It was released in 1999 by International Organization for Standardization based on ISO 9001, and the first edition was published in June 1999 as ISO/TS 16949:1999. IATF 16949:2016 replaced ISO/TS 16949 in October 2016 by International Automotive Task Force. The goal of it is provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and assembly process.
ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, providing requirements for any organization in the food industry with objective to help to improve overall performance in food safety. These standards are intended to ensure safety in the global food supply chain. The standards involve the overall guidelines for food safety management and also focuses on traceability in the feed and food chain.
Aero Space 9000 is an international standard for aerospace management systems that is a widely adopted and standardized quality management system for the aerospace sector. It was developed in 1998 by Society of Automotive Engineers.
In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something ; it is also defined as being suitable for the intended purpose while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is reliable, maintainable, or sustainable. In such ways, the subjectivity of quality is rendered objective via operational definitions and measured with metrics such as proxy measures.
TL 9000 is a quality management system standard designed by the QuEST Forum in 1998. It was created to focus on supply chain directives throughout the international telecommunications industry, including the USA. As with IATF 16949 for the automotive industry and AS9100 for the aerospace industry, TL 9000 specializes the generic ISO 9001 standard to meet the needs of one industrial sector, which for TL 9000 is the information and communications technology (ICT) sector—extending from service providers through ICT equipment manufacturers through the suppliers and contractors and subcontractors that provide electronic components, software components and services to those ICT equipment manufacturers.
ISO 31000 is a family of international standards relating to risk management codified by the International Organization for Standardization. The standard is intended to provide a consistent vocabulary and methodology for assessing and managing risk, resolving the historic ambiguities and differences in the ways risk are described.
A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report. The FAI process usually consists of fully testing and inspecting either the first part produced by the new process or a sample from the first batch of parts. First article inspection is typically a purchase order requirement of the purchaser for the supplier to complete. If the manufacturer doesn't have the in-house capability or if the purchaser requests, the first article inspection may be conducted by an approved subcontract supplier such as a dimensional inspection/metrology laboratory.
ISO 10007 "Quality management — Guidelines for configuration management" is the ISO standard that gives guidance on the use of configuration management within an organization. "It is applicable to the support of products from concept to disposal." The standard was originally published in 1995, and was updated in 2003 and 2017. Its guidance is specifically recommended for meeting "the product identification and traceability requirements" introduced in ISO 9001:2015 and AS9100 Rev D.
Nigel Howard Croft is a globally recognized authority on quality management and conformity assessment. He retired as Chairman of the ISO Joint Technical Coordination Group for Management System Standards in December 2023 after serving a three-year term, having been appointed by ISO's Technical Management Board in December 2020. During his tenure, he coordinated the deployment of the ISO London Declaration on Climate Action into all ISO Management System Standards, requiring organizations that implement these standards to determine the extent to which climate change can affect their results and the ways in which their activities can have a impact on climate change. This can then lead to the implementation of risk-based adaptation and mitigation strategies. Dr Croft was previously Chair of the ISO Technical Committee TC 176/SC 2 from February 2010 until December 2018, with overall responsibility for the ISO 9001 standard, used worldwide as a basis for certification of quality management systems, and the ISO 9004 guidelines standard aimed at improving organisational performance, among others. In 2019 and 2020 he led the revision of "Annex SL" of the ISO Directives, that forms the basis for over 40 management system standards including those on environmental management, Occupational Health and Safety, Information Security, Anti-bribery, Food Safety, Artificial Intelligence and many more.
DQS Holding GmbH based in Frankfurt am Main is the holding company of the worldwide DQS Group. The group provides assessments and certifications of management systems and processes of any type.
The Allied Quality Assurance Publications (AQAP) are standards for quality assurance systems developed by NATO.