ISO STANDARDS
ISO 9001:2008 - is a general quality standard adopted globally by the majority of manufacturers and service companies throughout the world. It's basically a set of rules that all companies consistently follow and is recognized world wide.
ISO 13485 - is the medical standard. Companies supplying equipment, instruments, single use product, test equipment and software categorized as a class II, III, or IV device must be registered to this standard to be allowed to import, manufacture or distribute their product in Canada or the United States in accordance with Health Canada and the FDA.
ISO 14001 - is the environmental standard which can be adopted by all industry sectors. This standard outlines the Aspect & Impact analysis that a company has on the environment. It includes targets for emission reduction, ERP, adherence to local and federal regulations and the 3 R's.
ISO 17025 - is the laboratory standard. This standard includes testing and calibration facilities. Testing would include chemical, metallurgical, biochemical, human tissue & fluid testing and forensic test facilities, Companies offering services of this nature are required at a minimum to be registered to this standard.
AS 9100 - is an aerospace standard which is implemented by manufacturers supplying materials, components and services to the aircraft, space and military industries. This standard is very comprehensive encompassing all of ISO 9001 plus additional industry requirements and that of aviation regulatory bodies.
ISO TS 16949 - is an international standard encompassing ISO 9001 plus requirements of the major automotive manufacturers. Suppliers wanting to conduct business with the OEM's who subscribe to this standard, are required to be registered to this standard by a governing body. (ie: recognized registrars)
ISO 18001 - is the Occupational Health and Safety standard. This standard can be adopted as a stand alone, however it is usually developed as an addition to ISO 9001 or some other base standard. This standard sets out a set of requirements to promote a safe working environment through the adherence to safety guidelines as set out in the standard.
ISO 22000 - is the ISO standard adopted by the food industry. This standard addresses the requirements specific to food production, processing and packaging. included in this standard are all the requirements of ISO 9001 plus regulatory, contractual and GMP requirements.
"Quality - has no time constraints" J. Mahn
This page was last updated: May 18, 2011
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