What does it all mean?

A brief outline of common quality standards

If you do a lot of purchasing, you see them all the time: those little logos with numbers and letters displayed proudly on company web sites letterheads, brochures and even on buildings. Here is a by-no-means complete list of some common standards and what they mean.

The ISO standards - the ISO 9000 family

This group of standards is concerned with quality management systems.

ISO 13485 - QMS standard for the medical device industry

ISO 13485 is based on the ISO 9001:2000 standard for quality management along with requirements specific to medical devices. ISO 13485:2003 replaced the 13485:1996 and 13488:1996 standards.

ISO 10993 - Biological evaluation of medical devices

ISO 10993 covers the procedural requirements for biological evaluation of medical devices and consists of 18 sections.

ISO 11134 - Sterilization of health care products

ISO 11134 covers the procedural requirements for validation and routine control of industrial moist-heat sterlilization.

EN 46001 - European Union Medical Device Directive

This standard uses ISO 9001:1994 as a baseline. A requirement for CE marking that enables sale of medical devices to member nations of the European Union.

ISO 10012:2003 - Measurement management systems

ISO 10012:2003 is the standard for measurement processes and equipment.

ISO/IEC 17025 - Requirements for the competence of testing and calibration laboratories

The latest standard for competence of testing and calibration laboratories is ISO/IEC 17025:2005.

ISO/TS 16949:2003 - QMS standard for the automotive industry

An application of ISO 9001:2000 for automotive production and related parts service organizations.

QS 9000 - outdated customer requirement for the US auto industry

QS 9000 was originally implemented by three large US automobile makers: DaimlerChrysler, Ford and General Motors. It is not a quality standard but a *customer requirement* - that is, if you want to sell your product to these US automakers, these were the guidelines to which your company was to adhere. QS 9000 referenced the now obsolete ISO 9001:1994 and 9002:1994 standards. The QS 9000:1998 designation becomes totally obsolete in December 2006. Many companies with QS 9000 designation will transition to ISO/TS 16949:2002.

AS 9100 - standards for the aerospace industry

Developed by the International Aerospace Quality Group, this standard contains the requirements of ISO 9001:2000 and an additional 80 requirements specific to the aerospace industry.

More ISO standards - the ISO 14000 family

This group of standards is concerned with environmental policies and procedures.