Quality standards

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: 

1. Customer improvement – understand customer needs and expectations and align company objectives with them; then pursue customer satisfaction by meeting/exceeding customer requirements and building customer relationships 
2. Leadership – implement leadership principles including vision, goal-setting, modeling, trust, empowerment, and recognition 
3. Engagement of people – invest in employee empowerment, communication, accountability, and recognition 
4. Process approach – manage and measure activities as processes with value-adding inputs, steps, and outputs as well as interfaces with other processes 
5. Improvement – plan, enact and measure improvements to company performance and capabilities, and recognize successful improvements
6. Evidence-based decision making – emphasize data collection and analysis, appropriately balanced with practical experience
7. Relationship management – manage the supply chain and collaborate toward quality 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.

Additional benefits: