ISO/IEC Guide

ISO/IEC 17025 replaces ISO/IEC Guide 25 and defines the internationally-accepted criteria for the technical evaluation of laboratories in the future. 

Currently laboratories seek accreditation to ISO/IEC Guide 25 but this is being replaced by ISO/IEC 17025 in 2000. 

Check that your external laboratories are accredited to ISO/IEC Guide 25 as a minimum. 

ISO/IEC Guide 14025, General Requirements for the Competence of Testing and Calibration in Laboratories, International Organization of Standardization, Geneva (2000). Also available on the World Wide Web http //www.iso.ch/iso/en/iso9000-14000/index.html. 

The operation of proficiency testing schemes is described in the harmonized protocol produced by IUPAC [1]. Further information can be found in ISO/IEC Guide 43 [2] and ILAC Guide 13 [3],... 

Proficiency Testing by Interlaboratory Comparisons - Part 1 Development and Operation of Proficiency Testing Schemes , ISO/IEC Guide 43-1 1997, International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC), Geneva, Switzerland, 1997. 

In addition it is important that there is dialogue and co-operation by the laboratory with its customers. This is also required by virtue of the EN 45001 Standard at paragraph 6, and will be emphasised even more in future with the adoption of ISO/IEC Guide 17025.8... 

In addition, the bodies assessing the laboratories should comply with the general criteria for laboratory accreditation, such as those laid down in the ISO/IEC Guide 58 1993 Calibration and testing laboratory accreditation systems -General requirements for operation and recognition .13... 

Thus, as for the European Union, the requirements are based on accreditation, proficiency testing, the use of validated methods of analysis and, in addition, the formal requirement to use internal quality control procedures which comply with the Harmonised Guidelines. Although the EU and Codex Alimentarius Commission refer to different sets of accreditation standards, the ISO/IEC Guide 25 1990 and EN 45000 series of standards are similar in intent. It is only through these measures that international trade will be facilitated and the requirements to allow mutual recognition to be fulfilled will be achieved. 

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Calibration and Testing Laboratory Accreditation Systems — General Requirements for Operation and Recognition — ISO/IEC Guide 58, Geneva, ISO, 1993. 

International Vocabulary of Metrology — Basic and General Concepts and Associated Terms IM, 3 edtion, ISO/IEC Guide 99 2007, www.bipm.org)... 

ISO/IEC Guide 2 2004, Standardisation and related activities - General vocabulary... 

ISO/IEC Guide 98 1995 Guide to the expression of uncertainty in measurement (GUM), also available as JCGM 100 2008 from www.bipm.oig... 

Opinions and interpretations should not be confused with inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC Guide 65. 

Definitions referring to these activities are given in ISO/IEC Guide 2 2004, EN 45020 2006 and some other normative documents, namely ISO/IEC 9000 2005 and ISO/IEC 17000 2004. Definitions for accreditation and certification given in ISO/IEC Guide 2 are used in the following discussion. 

The first documents dealing with the competence of laboratories were ISO/IEC Guide 25 and EN 45001 standard. They were issued to provide the necessary basis to be used by laboratories and by the bodies that assess their technical performance. In parallel, accreditation bodies nnder-took additional tasks with regard to the assessment of other activities (certification of products and systems) as specified in other EN 45000 series standards. The ISO/IEC 17025 has replaced EN 45001 (see slide 40), while other standards within EN 45000 series have been replaced by the ones in ISO/IEC 17000 series. 

The drafting of an ISO standard on laboratory accreditation to be used instead of EN 45001 was a need for international trade. ISO/IEC Guide 25 could not be used for this purpose since it was just a guide. However other needs were also reflected in the new standard, namely the ones related to the question accreditation vs. certification for laboratories and how to face problems arising from the existing confusion. 

Both the ISO 9000 guidelines (ISO/IEC Guide 25 — see Section 2) and the GLP regulations (e.g., FDA regulations 21 CFR 58) stress the importance of the calibration of laboratory equipment. (See Box 5.3.) Indeed, properly calibrated test equipment is central to a laboratory s duty to successfully and accurately carry out its responsibilities. 

The NVLAP is comprised of a series of laboratory accreditation programs (LAPs), depending on what is requested and what is needed. Each LAP includes specific calibration and/or test standards and related methods and protocols assembled to satisfy the unique needs for accreditation in a field of testing or calibration. NVLAP accredits public and private laboratories based on evaluation of their technical qualifications and competence to carry out specific calibrations or tests. All are based on the ISO/IEC Guide 25 discussed in Section 2. The process involves an application and the payment of fees. This is followed by an on-site assessment. If deficiencies are found, these must be resolved to the satisfaction of the assessment team. The laboratory then participates in proficiency testing (Section 5.7) and a technical evaluation. 

The AALA accreditation is also based on the ISO/IEC Guide 25. This accreditation indicates that a laboratory has demonstrated that it is competent to perform specific tests or specific types of tests that its quality system addresses and conforms to all elements of the Guide 25 and is fully operational and that it conforms to any additional requirements of AALA or specific fields of testing or programs necessary to meet particular user needs. 

How does a laboratory facility become accredited What role does the ISO/IEC Guide 25 play in accreditation by AALA or NVLAP ... 

European Committee for Normalisation (CEN), (2006), Standardization and related activities—General Vocabulary (from ISO/IEC Guide 2 2004), EN45020 2006, www. cenorm.be. 

In terms of criteria for the approval of private certification bodies, the EU regulation requires compliance to Annex 3 of the regulation in addition to ISO/IEC Guide 65. Annex 3 contains requirements not included in ISO Guide 65 such as parallel production. This format is similar to the IFOAM system with specific accreditation criteria that are not covered in the ISO guide. The USA and Japan have each developed distinct requirements. Beyond this, some countries such as India and Australia (in draft requirements) have chosen to base their criteria on IFOAMs (Commins 2003). 

Method validation has received considerable attention in the literature and from industrial committees and regulatory agencies. The international standard ISO/ IEC [1] requires validation of nonstandard methods, laboratory designed/devel-oped methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are suitable for their intended use. The Guidance on the Interpretation of the EN 45000 Series of Standards and ISO/IEC Guide 25 includes a chapter on the validation of methods [2] with a list of nine validation parameters. The International Conference on Harmonization (ICH) of Technical Requirements for the... 

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