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Quality standards are sets of good management practices, methods, systems, requirements, and/or specifications established by industry advisory groups to help manufacturers achieve and demonstrate consistent production and product quality. Some quality standards are applicable to a broad spectrum of manufacturing and service organizations, while others are industry specific
ISO 9000 and ISO 9001 – Published by the International Organization for Standardization (ISO), ISO 9000 is a family of standards and ISO 9001 is a standard within the ISO 9000 family, both setting out good management practices for quality management systems (QMS).
IATF 16949 – Developed by members of the International Automotive Task Force (IATF) and approved and published by ISO, IATF 16949 defines the requirements for quality management systems used by the automotive industry.
IAQG 9100 – The International Aerospace Quality Group (IAQG) has laid out standards for quality management systems for aviation, space, and defense organizations. Like IATF 16949, the IAQG 9100 standard is built upon the ISO 9001 standard such that compliance with the former entails compliance with the latter.
IRIS – The International Railway Industry Standard (IRIS) establishes a global system for evaluation of quality outcomes from manufacturers that supply the railway industry.
FDA 21 CRF Part 11 – Commonly referred to simply as Part 11, this US Food and Drug Administration (FDA) standard applies to FDA-regulated industries including pharmaceuticals, medical devices,s and diagnostics, and biotech companies. It establishes requirements for manufacturing software system control, validation, auditing, and documentation.
GMP/GLP – Good Manufacturing Practices and Good Laboratory Practices are regulations established by the US FDA for healthcare product manufacturers, especially those using laboratories and process manufacturing.
Generally, manufacturing quality standards are designed – as the name suggests – to standardize the methods, elements, QMS, and other systems, auditing, certification, and/or documentation that manufacturers use to ensure consistent quality across industry and (often) across the globe. Quality standards may include guidelines for quality planning, control, and monitoring phases of production. They also may incentivize companies to pursue continuous improvement initiatives through closed-loop quality systems.
Some quality standards were initially developed in response to concerns about a significant level of consumer complaints. They often require companies to implement effective and efficient complaint management mechanisms.
Manufacturing quality standards have evolved toward an emphasis on practices over less flexible specifications and directives. This leaves in the hands of the individual manufacturing company decisions about how best to implement the standard, given the particulars of their operation.
The ISO 9000:2015 standard on which many quality standards are based specifies seven quality management principles designed to guide companies toward improvement:
As manufacturing companies pursue certification and then the maintenance of their quality management systems and practices, they almost always improve quality outcomes of their operations, and may also increase efficiency and decrease costs.
Increased customer satisfaction
Improved product and production safety
Assurance of regulatory compliance
Reduced errors and recalls
Support of a globalized marketplace
Competitive advantage over uncertified companies