• To establish a single international standard to corroborate the competence of laboratories to carry out testing and/or calibration, including sampling. Such a basic standard facilitates the establishment of mutually recognised agreements between national accreditation organs;
  
• To facilitate interpretation and application of the requirements, avoiding divergent and conflicting opinions as far as possible. Since 17025 contains a large number of notes containing full explanations of the text, together with examples and guidance, this norm reduces the need for consulting additional explanatory documents;
  
• Broadening the scope of ISO Guide 25 to take into account sampling and development of new methods;
  
• To establish a closer, more transparent and unambiguous relationship with ISO 9001 and 9002 ( 17025 dates from 1999, prior to the issuing of 9001:2000).

The main modifications introduced by 17025 regarding ISO Guide 25 can be divided into two groups: structural and situational changes. The structural changes concern the introduction of new concepts and approaches as well as the ordering and presentation of the requirements listed in ISO/IEC 17025, the structure of which is completely different from that of ISO Guide 25. These constitute differences not just in form but also in content, and clearly demonstrate the concern of the new norm to lay down modern, overall guidelines to assist laboratories to develop reliable management of their activities in accordance with internationally-recognised quality standards. In addition, the inclusion of more detailed requirements of a technical nature, (treated superficially in ISO Guide 25), will enable laboratories to demonstrate their technical competence in a more consistent manner. Among the main changes of structural character introduced by the 17025 the following are of note:

• In ISO/IEC 17025, a clear dividing line exists between the managerial and technical requirements: section 4 contains requirements for management, while section 5 specifies those related to the technical competence involved in testing and/or calibration exercises done by the laboratory in question. Doing evaluations, both externally and internally, is made easier as the result of this division of responsibilities.
  
• Closer attention should be paid to the clients of the laboratory (item 4.7 - Customer Service). Better contact with customers should be made a priority insofar as contractual matters are concerned, and also regarding access by the client to certain areas of the laboratory so that they can be present when the tests and /or calibrations are actually being carried out. Although it is difficult to place a monetary value on such activities, all laboratories should nevertheless be encouraged to establish channels of communication and thereby obtain feedback from the customers;
  
• Also included was the requirement dealing with preventive actions to be taken by the laboratory (item 4.11), as a result of which opportunities for improvements in performance may be identified;
  
• As the result of broadening the scope for developing new methods for laboratories (item 5.4.3), a series of criteria and specific guidelines was established for the validation of methods (item 5.4.5);
  
• Compatibility and convergence with norms ISO 9001/9002. All the requirements of 9001/9002 were incorporated in ISO/IEC 17025 (for example, preventive action) relevant within the scope of the testing and calibration services provided by the laboratory quality system. Therefore, if the testing and calibration laboratories fulfil all the requirements of norm 17025, they will operate a quality system which in addition will meet the provisions of 9001 or 9002. In short, in order to secure accreditation of a particular laboratory, a quality system is obviously needed, but its mere existence is not sufficient fully to meet the requirements of 17025, since laboratories will still need to demonstrate their technical competence to produce technically valid data and results. This is not covered by 9001 or 9002. With the new version of ISO 9001:2000, it is probable that ISO/CASCO will bring together a task force to study the possibility of technical amendments which need to be made to bring ISO/IEC 17025:1999 into line with ISO 9001:2000.
  

The second group of changes introduced by 17025, in comparison with ISO Guide 25, are situational differences, namely the kind of improvements and modifications carried out as and when called for. The latter in themselves can act as a starting point for evolving managerial and technical competence matters previously dealt with in ISO Guide 25 - these gave rise to doubts, omissions and disagreements on account of their having been drafted in a relatively narrow way. The following are among the main changes made:

• Definition of the minimum content to be taken into account in the declaration of quality policy of the laboratory;
  
• Inclusion of a specific requirement (item 4.10) for the implementation of corrective actions;
  
• As a result of aligning ISO/IEC 17025 with ISO 9001 and 9002, item 4.4 details in depth the critical analysis activity of requests, proposals and contracts, in such a way as to inculcate a greater degree of customer confidence in the services delivered by the laboratory, and finally to improve laboratory-customer relationships;
  
• The tracing of the calibrations is dealt with in a detailed and wide-ranging manner under item 5.6. This item contains many useful explanatory and guidance notes. It should be noted that under ISO/IEC 17025, the tracing to be demonstrated by the calibration laboratories (item 5.6.2.1) differs from that of the testing laboratories (item 5.6.2.2);
  
• More emphasis is also placed upon the presentation of tests and measurements than that encompassed by ISO Guide 25. There is a clear distinction between the issuing of test reports (item 5.10.3) and that of measurement certificates (item 5.10.4). Under item 5.10.5, the requirements to be fulfilled by the laboratory are specified when opinions and different interpretations are to be included in a test report. This procedure was not laid down previously in ISO Guide 25.
  

At first sight, the modifications introduced by ISO/IEC 17025:1999 give the impression of having transformed it into a more rigorous and " heavy " norm than Guide 25. The fact remains that the former is currently much broader and descriptive. However, careful examination of norm 17025 confirms that precisely because it is more detailed and explanatory, it can be applied more pragmatically and far less ambiguously than ISO Guide 25. The rules of the game were effectively brought up to date, the requirements were made clearer, obscure points were better explained and, in the light of demand from the laboratories, and as a result of the proliferation of the use of quality systems, there was complete convergence with the requirements of ISO 9001 and 9002. As mentioned previously, in a not too distant future it will be necessary to bring ISO/IEC 17025 into line with the new ISO 9001:2000.

In the globalised world, standardization is of the utmost importance for facilitating and increasing trade at regional, national, and international levels. Organizations that develop their activities and operate manufacturing or productive processes in accordance with norms and "harmonized" procedures based upon commonly accepted standards, will be in a more favorable position to overcome possible non-tariff barriers, as well as to meet specified technical targets. In this respect, application of ISO/IEC 17025 is of enormous relevance from an economic point of view, since it confers a differentiated value to the test and calibration certificates issued by laboratories - whose technical competence in turn is acknowledged by an "accreditation entity ". Recognition as such obviously carries economic advantages for the laboratories concerned, such as:

• Competitive differential(s), which constitute an important factor in marketing and product information dissemination. This can result in higher market acceptability and, naturally, enhanced profitability;
  
• Current client fidelity and ability to attract new customers, since accreditation effectively confirms and acknowledges the technical competence of the laboratory to produce technically valid data, which in turn increases the credibility of the laboratory in the market;
  
• Laboratories that are part of larger organizations and operate in accordance with the requirements of ISO/IEC 17025, can prove that the products of the particular organization have been tested and are technically capable of meeting performance, safety and reliability specifications;
  
• The growth of product certification activities represents a new market to be exploited by the testing and /or calibration laboratories;
  
• The testing and /or calibration results can be accepted in other countries, providing that the laboratory uses the criteria laid down by ISO/IEC 17025 and is accredited by an official body that has concluded reciprocally recognised agreements with equivalent organisations in other countries. This is for example the case of INMETRO, which recently established a mutual recognition agreement with the European Co-operation Agency for Accreditation;
  
• To meet the legal requirements of the regulatory authorities, such as the Brazilian National Health Surveillance Agency;
  
• The use of ISO/IEC 17025 will facilitate cooperation between laboratories and other bodies, greatly contributing to the exchange of information and experience, as well as in the harmonization of norms and procedures, all of which can lead to reductions in costs.
  
  

In short, the adaptation of the managerial and technical activities of laboratories in accordance with the criteria laid down by ISO/IEC 17025 should be regarded not as an overhead cost but rather as a medium to long term investment. This investment could well result in guaranteed commercial and financial return as the technical competence of the laboratories becomes accepted by the market.

Authors
Benjamin Valle - Economist, Master's Degree in Production Engineering and Consultant in Quality Systems (rumoq@fst.com.br).
Galdino Guttmann Bicho - General Manager of Laboratories of Public Health Laboratories of the Brazilian National Health Surveillance Agency (reblas@anvisa.gov.br).

Bibliographical references
BUG, Galdino Guttmann and VALLE, Benjamin. Guide 25 - The ISO of the Laboratories, Revistas Banas Qualidade. São Paulo, no. 85, June/99.
ISO/IEC 17025:1999(E). General requirements for the competence of testing and calibration laboratories. Geneva, first edition 1999-12-15.
SQUIRRELL, Allan. ISO/IEC 17025 - Aims and main features. Lecture given at ENLAB 2000. São Paulo, 4 to 7 December , 2000.