Method validation is one of the measures universally recognized as a necessary part of a comprehensive system of quality assurance in analytical chemistry. In the past, ISO, IUPAC, and AOAC International have cooperated to produce agreed protocols or guidelines on the "Design, conduct and interpretation of method performance studies" [1], on the "Proficiency testing of (chemical) analytical laboratories" [2], on "Internal quality control in analytical chemistry laboratories" [3], and on "The use of recovery information in analytical measurement" [4]. The Working Group that produced these protocols/guidelines has now been mandated by IUPAC to prepare guidelines on the single-laboratory validation of methods of analysis. These guidelines provide minimum recommendations on procedures that should be employed to ensure adequate validation of analytical methods. A draft of the guidelines has been discussed at an International Symposium on the Harmonization of Quality Assurance Systems in Chemical Laboratory, the proceedings from which have been published by the UK Royal Society of Chemistry.

The international standardizing organizations - International, ISO, and IUPAC - cooperated to produce the International Harmonized Protocol for the Proficiency Testing of (Chemical) Analytical Laboratories. The Working Group that produced the protocol agreed to revise that Protocol in the light of recent developments and the experience gained since it was first published. This revision has been prepared and agreed upon in the light of comments received following open consultation.