Standards And Guides

Laboratory accreditation is now well-harmonized internationally, with international standards and guides available for both the accrediting bodies and those being accredited.

Additionally, the international body, ILAC, and its Regional Cooperation Body members, have developed a number of guidance and information documents to assist the consistent implementation of accreditation practices. These documents are available on the ILAC, APLAC, EA, IAAC and SADCA websites.

The standards and guides of most relevance to accreditation bodies and their clients have been produced by the International Organization for Standardization (ISO), often in collaboration with the International Electrotechnical Commission (IEC), and most of these by the special policy committee of ISO dedicated to conformity assessment issues, namely CASCO.

Most of the relevant Standards have been produced by the special policy committee of ISO dedicated to conformity assessment issues, namely CASCO.

The most significant standards and guides are as follows:

For Accreditation Bodies

• ISO/IEC 17011:2004 Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies;
• ISO/IEC 17000:2004 Conformity assessment-Vocabulary and general principles;
• ISO/IEC Guide 43-1:1997 Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes (To be replaced by ISO/IEC 17043 which is currently under development by CASCO);
• ISO/IEC Guide 43-2:1997 Proficiency testing by interlaboratory comparisons-Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies (to be replaced by ISO/IEC 17043 which is currently under development by CASCO);and
• The IAF/ILAC A-series of documents. (These joint ILAC and IAF documents - available from their websites- provide harmonized procedures for the evaluation of accreditation bodies seeking to become signatories to the ILAC MRA and IAF MLA).

For Clients of Accreditation Bodies

• ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories;
• ISO 15189:2003 Medical Laboratories-Particular requirements for quality and competence;
• ISO/IEC Guide 43 (as above-proficiency testing is also of relevance to both accredited laboratories and proficiency testing providers which might seek accreditation by ILAC Members);
• ISO/IEC 17020:1998 General criteria for the operation of various types of bodies performing inspection (In addition to accrediting laboratories, many ILAC Members also accredit inspection bodies);
• ILAC G13:08/2007 Guidelines for the requirements for the competence of providers of proficiency testing schemes. (Some ILAC members use this document to accredit proficiency testing providers: it, is also expected to be replaced by the forthcoming new standard, ISO/IEC 17043);
• ISO Guide 34:2000 General requirements for the competence of reference material producers. (Some ILAC Members also accredit reference material producers).

For information on ISO Standards and CASCO refer to the website

www.iso.org .

Information on the International Electrotechnical Commission (IEC) and its standards is available at www.iec.ch.