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 five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. 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. ISO/TS 9002 offers guidelines for the application of ISO 9001. ISO 9004 gives guidance on achieving sustained organizational success.
An audit is an "independent examination of financial information of any entity, whether profit oriented or not, irrespective of its size or legal form when such an examination is conducted with a view to express an opinion thereon." Auditing also attempts to ensure that the books of accounts are properly maintained by the concern as required by law. Auditors consider the propositions before them, obtain evidence, roll forward prior year working papers, and evaluate the propositions in their auditing report.
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a shift left since it focuses on quality efforts earlier in product development and production and on avoiding defects in the first place rather than correcting them after the fact.
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
DO-178B, Software Considerations in Airborne Systems and Equipment Certification is a guideline dealing with the safety of safety-critical software used in certain airborne systems. It was jointly developed by the safety-critical working group RTCA SC-167 of the Radio Technical Commission for Aeronautics (RTCA) and WG-12 of the European Organisation for Civil Aviation Equipment (EUROCAE). RTCA published the document as RTCA/DO-178B, while EUROCAE published the document as ED-12B. Although technically a guideline, it was a de facto standard for developing avionics software systems until it was replaced in 2012 by DO-178C.
ARP4754, Aerospace Recommended Practice (ARP) ARP4754B, is a guideline from SAE International, dealing with the development processes which support certification of Aircraft systems, addressing "the complete aircraft development cycle, from systems requirements through systems verification." Revision A was released in December 2010. It was recognized by the FAA through Advisory Circular AC 20-174 published November 2011. EUROCAE jointly issues the document as ED–79.
RTCA DO-254 / EUROCAE ED-80, Design Assurance Guidance for Airborne Electronic Hardware is a document providing guidance for the development of airborne electronic hardware, published by RTCA, Incorporated and EUROCAE. The DO-254/ED-80 standard was formally recognized by the FAA in 2005 via AC 20-152 as a means of compliance for the design assurance of electronic hardware in airborne systems. The guidance in this document is applicable, but not limited, to such electronic hardware items as
IEC 61508 is an international standard published by the International Electrotechnical Commission (IEC) consisting of methods on how to apply, design, deploy and maintain automatic protection systems called safety-related systems. It is titled Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems.
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.
Parts Manufacturer Approval (PMA) is an approval granted by the United States Federal Aviation Administration (FAA) to a manufacturer of aircraft parts.
In the United States, the Single Audit, Subpart F of the OMB Uniform Guidance, is a rigorous, organization-wide audit or examination of an entity that expends $750,000 or more of federal assistance received for its operations. Usually performed annually, the Single Audit's objective is to provide assurance to the US federal government as to the management and use of such funds by recipients such as states, cities, universities, non-profit organizations, and Indian Tribes. The audit is typically performed by an independent certified public accountant (CPA) and encompasses both financial and compliance components. The Single Audits must be submitted to the Federal Audit Clearinghouse along with a data collection form, Form SF-SAC.
The Home Energy Rating is an American estimated measurement of a home's energy efficiency based on normalized modified end-use loads (nMEULs). In the United States, the Residential Energy Services Network (RESNET) is responsible for creation and maintenance of the RESNET Mortgage Industry National Home Energy Rating Standards (MINHERS), a proprietary system of standards, which includes standards language for the certification and quality assurance for RESNET Provider organizations. RESNET is an EPA recognized Home Certification Organization (HCO) that also help's create standards in compliance with the American National Standards Institute, namely ANSI 301, ANSI 310, ANSI 380, and ANSI 850. The Building Science Institute, Ltd. Co. (BSI) is another EPA recognized HCO that maintains the ANSI Standards to produce Energy Ratings and compliance with above-code programs such as the ENERGY STAR New Homes Program.
ISO/IEC 27006 is an information security standard published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Part of the ISO/IEC 27000 series of ISO/IEC Information Security Management System (ISMS) standards, it is titled Information technology - Security techniques - Requirements for bodies providing audit and certification of information security management systems.
CSA CAN3-Z299 is a series of quality assurance standards developed by the Canadian Standards Association in the 1970s. It is an alternative to the ISO 9000 series of standards. The stated objectives of the Z299 series of standards are:
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.
The ASME Boiler & Pressure Vessel Code (BPVC) is an American Society of Mechanical Engineers (ASME) standard that regulates the design and construction of boilers and pressure vessels. The document is written and maintained by volunteers chosen for their technical expertise. The ASME works as an accreditation body and entitles independent third parties to inspect and ensure compliance to the BPVC.
Accredited Crane Operator Certification OSHA regulation 29 CFR 1926 Subpart CC, released August 9, 2010, requires crane operators involved in construction to be certified by an accredited certification provider by November 10, 2014. An operator is defined as any person operating the equipment. To be accredited, certification providers must be accredited by a nationally recognized accrediting agency, defined as "an organization that, due to its independence and expertise, is widely recognized as competent to accredit testing organizations. Examples of such accrediting agencies include, but are not limited to, the National Commission for Certifying Agencies and the American National Standards Institute." This is the first time certification by an accredited certification provider has been required on a national level, although individual states and cities have required crane operator certification as far back as 2000. The new OSHA standards make the completion of this requirement an important topic of knowledge for the crane and lifting industry.
A mill test report (MTR) and often also called a certified mill test report, certified material test report, mill test certificate (MTC), inspection certificate, certificate of test, or a host of other names, is a quality assurance document used in the metals industry that certifies a material's chemical and physical properties and states a product made of metal complies with an international standards organization specific standards.
ASME QME-1 is a standard maintained by the American Society of Mechanical Engineers that provides the requirements and guidelines for the qualification of active mechanical equipment (QME) whose function is required to ensure the safe operation or safe shutdown of a nuclear facility.
