ISO/IEC

Laboratory product identification and testing. Requirement addressed by ISO/IEC 17025. 

Are all in-house inspection, testing, and calibration laboratories compliant with the requirements of ISO/IEC 17025 ... 

The standard requires that where inspection, testing, and calibration services are conducted fay a supplier s laboratory facility, the laboratory shall comply with ISO/IEC 17025 including use of a laboratory scope. 

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

There are two sources of confusion with this requirement. First is the issue of accreditation and second is the difference between ISO/TS 16949 and ISO/IEC 17025. 

ISO/TS 16949 states that accreditation of supplier facilities to ISO/IEC 17025 or national equivalent is neither required nor does it satisfy all requirements in ISO/TS 16949. It can also be said that ISO/TS 16949 does not satisfy all the requirements of ISO/IEC 17025. Hence, ISO/IEC 17025 is the equivalent of ISO/TS 16949 for the calibration sector. 

As ISO/IEC 17025 does not cover some of the system elements, your laboratory should therefore be subject to audit against the relevant requirements of ISO/TS 16949. 

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

Assess your internal laboratories against ISO/IEC 17025 and act on the differences. 

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

Don t assume that a laboratory that is registered to ISO 9002 - whether internal or external - can meet the requirements of ISO/IEC 17025. 

ISO (1990) ISO/IEC 25 General requirements for the competence of calibration and testing laboratories and ISO/IEC DIS 17025 General requirements for the competence of testing and calibration laboratories. International Standards Organization, Geneva. 

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. 

Medical laboratories have some specific needs and these are incorporated in ISO 15189 2003, Medical Laboratories - Particular Requirements for Quality and Competence [8]. The requirements of both ISO 9001 and ISO/IEC 17025 are incorporated within this Standard. It is a customized version of ISO/IEC 17025 for medical laboratories. In the UK, UKAS have designated Clinical Pathology Accreditation (UK) Ltd as the authoritative body to accredit against this Standard. 

This Standard was prepared specifically to cover medical laboratories. These laboratories carry out testing or examination of materials derived from the human body. Such studies are carried out for the purpose of providing information for the diagnosis, prevention and treatment of disease or assessment of the health of an individual. ISO 15189 covers a whole range of tests relating to clinical measurements, e.g. chemical and microbiological. This Standard is based on ISO 9001 and ISO/IEC 17025 and contains a correlation between the clauses and those in ISO 9001 and ISO/IEC 17025. 

The terminology used in this Standard is slightly different from the others in that it is appropriate for the particular discipline. For example, the term, referral laboratories in paragraph 4.5 of ISO 15189 is used in a slightly different sense to the comparable clause in ISO/IEC 17025. Included in this section are consultants who may provide a second opinion. If the referral laboratory is an external laboratory, to which samples are submitted for a supplementary or confirmatory examination procedure and report, it is much the same as a contract laboratory in ISO/IEC 17025. There is an extra Annex in this Standard which covers the ethics applicable to laboratory medicine. 

It can be seen that the GLP principles do cover similar requirements to both ISO 9001 and ISO/IEC 17025 but data generated solely under these standards would not generally satisfy the principles of GLP. This is mainly in the area of documentation. 

General Requirements for the Competence of Testing and Calibration Laboratories , ISO/IEC 17025 2005, International Organization for Standardization (ISO)/Intemational Electrotechnical Commission (IEC), Geneva, Switzerland, 2005. 

Sampling is the process of selecting a portion of material, in some manner, to represent or provide information about a larger body of material. ISO/IEC 17025 defines sampling as follows ... 

Method validation is defined in the international standard, ISO/IEC 17025 as, the confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled. This means that a validated method, if used correctly, will produce results that will be suitable for the person making decisions based on them. This requires a detailed understanding of why the results are required and the quality of the result needed, i.e. its uncertainty. This is what determines the values that have to be achieved for the performance parameters. Method validation is a planned set of experiments to determine these values. The method performance parameters that are typically studied during method validation are selectivity, precision, bias, linearity working range, limit of detection, limit of quantitation, calibration and ruggedness. The validation process is illustrated in Figure 4.2. 

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],... 

Some customers will require the results of the analysis to be interpreted or an opinion given, e.g. does the discharged water from the factory comply with the current legislation ) or how many cigarettes can be made from 2 kg of cannabis leaf There is now provision for this aspect of the work of an analyst to be included in the scope of accreditation of the laboratory to the Standard ISO/IEC 17025 2005 [1]. It is important to be clear about what is meant by Opinions and Interpretations. In the context of this book, it is the subjective expression given that is based on results, academic or scientific knowledge and experience gained over a period of time. 

As mentioned previously, it is possible to include opinions and interpretations within the scope of accreditation. It should be realized that the opinions and interpretations themselves are not accredited. This accreditation is only given if the work is already accredited to ISO/IEC 17025 [1]. What is required by the Standard is evidence of the procedure used by the laboratory to authorize an individual to give an opinion or interpretation. This means there has to be a procedure within the management system of the laboratory that sets out the criteria upon which the quality of the person giving the opinion is assessed. This may be split into two parts, namely the criteria for assessing competence and the criteria for assessing experience. 

UKAS Guidance on the Application of ISO/IEC 17025 Dealing with Expressions of Opinions and Interpretations , LAB13, United Kingdom Accreditation Service (UKAS), Feltham, UK, 2001. 

The management standards available have already been introduced and their general features highlighted in Chapter 2. Some of the more specific components of the Standards will be covered in this chapter. For general chemical laboratories, the two Standards that are most frequently encountered are ISO/IEC 17025 and GLP and so these will be covered more fully in the following sections. 

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