Quality standards

Quality standards are good management practices, methods, systems, requirements and 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.

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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, so compliance with the former entails compliance with the latter.

IRIS—The International Railway Industry Standard (IRIS) establishes a global system for evaluating quality outcomes from manufacturers that supply the railway industry.

FDA 21 CRF Part 11 – Commonly referred to as Part 11, this US Food and Drug Administration (FDA) standard applies to FDA-regulated industries, including pharmaceuticals, medical devices, diagnostics and biotech companies. It establishes requirements for manufacturing software system control, validation, auditing and documentation.

GMP/GLP – Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) are regulations established by the US FDA for healthcare product manufacturers, especially those using laboratories and process manufacturing.

Principles behind manufacturing quality standards

Generally, manufacturers design manufacturing quality standards to standardize methods, elements, QMS, auditing, certification, documentation and other systems. Manufacturers use these standards to ensure consistent quality across the industry and (often) across the globe.

Initially, concerns about significant consumer complaints prompted the development of some quality standards.

Manufacturing quality standards have evolved toward less flexible practices over specifications and directives. This approach leaves decisions in the hands of the individual manufacturing company to decide 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