Prominex Article: Manufacturing Quality Standards

ARTICLE: Manufacturing Quality Standards

Before the Industrial Revolution, most goods were entirely manufactured by a single individual or a small team of craftsmen who were responsible for every aspect of the production. With the advent of the assembly line, workers performed only one small part of the overall process and the subject of quality assurance became a separate department of the company. Today, quality management has evolved into a profession in itself and quality management systems are in place for most types of business and industry.

Quality standards now exist for every aspect of a company including:

personnel training and qualification
controlling the product design
controlling documentation
controlling purchasing
product identification and traceability at all stages of production
controlling and defining production and process
defining and controlling inspection, measuring and test equipment
validating processes
product acceptance
controlling nonconforming product
instituting corrective and preventive action when errors occur
labeling and packaging controls
handling, storage, distribution and installation
records
servicing
statistical techniques and others.

After World War II, delegates from 25 countries met with the purpose of creating an international system of industrial standards. In 1947, the International Organization for Standardization was formed and is headquartered in Geneva, Switzerland. Because the organization's name would have a different acronym in different languages, the name ISO was chosen, from the Greek isos meaning "equal."

ISO's main products are international standards. These exist in thousands of publications, guides, technical papers and reports. Standards have been established for everything from the direction of twist in yarns to shoe sizes to the Romanization of Chinese. As they relate to the metalworking industry and machine shop operations, the two primary families of ISO standards that apply are ISO 9000, which covers quality management systems used in production environments and ISO 14000, which covers environmental management standards in production environments.

Depending on a machine shop's clientele other ISO standards include ISO 13485:2003, which relates to production of medical devices, and ISO 16959:2002, relating to the automotive industry. The US Food and Drug Administration often requires that a company's manufacturing standards be registered with them as a prerequisite for doing business. The military also requires that shops comply with military specifications (MIL-SPEC) or military standards (MIL-STD). When supplying parts for original equipment manufacturers (OEM), the shop must certify its processes with the manufacturer's own internal requirements.

ISO only sets the standards. Independent auditing organizations around the world issue the certifications after the machine shop has demonstrated its compliance. Prominex receives regular audits by TÜV SÜD America, one of the world's leading auditing, testing, inspection and certification firms.