Motiva Training - Edgar Ned Gravel ISO 17025 Expert

Standards development organizations (SDOs) are those bodies that facilitate the development of consensus-based standards. 

Consensus-based standards usually have at least five people on the committees created to develop and/or modify them.  They include:

  • someone from the public sector,
  • someone from the private sector,
  • a manufacturer of the product or service under discussion,
  • a user of the same product or service, and
  • a recognized expert in that field. 

In some nations, SDOs are accredited by the national accreditation body in order to recognise their conformance to specific requirements.  In North America, the SDOs are formally recognised by their national standards bodies (ANSI and the SCC).

This list is shown in order of North American SDOs first, then International SDOs, both in alphabetical order.  If any important SDO is missing from this list, please send us a note at the addresses listed on our Contact Us page and we will add the missing information.

Click on the relavent menu item to the left of this page to get more information on the organisations that create the standards used within laboratories and accreditation bodies.

Regulators and Regulatory Specifications

No discussion of test specifications used in laboratories can be considered complete until regulatory authorities are discussed as well.  There are over 300 of these types of specifiers in North America. 

Unlike SDOs, regulators are less concerned about the fairness and universal applicability of the regulations, standards and specifications they develop, and much more concerned about protecting the health, welfare and safety of the citizens within their jurisdiction.

Over time, more regulatory specifiers are making use of consensus-based standards to assist them in their primary functions.  An excellent example is the increasing use of ISO/IEC 17025 and voluntary conformity assessment by ILAC-recognised accreditation bodies to take the place of regulatory inspections by the regulator.  Different regulatory agencies are at different points on this timeline. 

For example, US and Canadian National Building Codes make much more use of consensus base standards and voluntary conformity assessment than does the US FDA or Health Canada. This diagram shows the spectrum of approaches. 

The yellow line shows how ISO/IEC 17025 is now being called out by many regulatory programs in North America as an approach to allow laboratories to demonstrate conformance to regulatory requirements - and competence in the production of technically valid results.

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