Journal:ISO/IEC 17025: History and introduction of concepts

Abstract

Quality is an increasingly present concept nowadays, and meeting the needs of customers who buy and use products and hire services becomes essential. For laboratories, the concept is applied not only to the reliability and traceability of the results produced, but it also presents itself in meeting the customer’s needs and providing confidence when signing agreements in the international trade. The concept of quality in a laboratory can be carried out from the development and implementation of a quality management system (QMS). To this end, the normative, internationally accepted document ISO/IEC 17025 aims at instructing the development and implementation of a management system, which ideally proves the technical capacity of testing and calibration laboratories and guides the generation of reliable results. The document is in its third version as a standard, the most current one published in 2017, and it presents requirements to achieve the proposed objective of quality assurance. In the face of the importance of these concepts and the unquestionable need of laboratories to provide reliable and traceable results, this article presents the normative history of ISO/IEC 17025 and its most recent changes. Its intent is to support laboratories whose objective is to implement a QMS according to this normative reference.

Keywords: quality management system, quality assurance, laboratory accreditation, traceability, reliable results

Introduction

Testing and calibration laboratories are organizations which provide measurement results, and important decisions are typically based on these these. Given the great responsibility of these laboratories, being able to assure the quality of their service and the reliability of their reported results is important. In order to demonstrate their competence, laboratories throughout the world turn to the ISO/IEC 17025 standard. This document proposes the development and implementation of a quality management system (QMS) that ensures a high level of quality control and metrological traceability. Additionally, ISO/IEC 17025 better facilitates access to world markets and provides domestic and international socio-economic benefits. [1]

For the sake of making knowledge about ISO/IEC 17025 increasingly more accessible, this article presents the concept of quality, how this concept has applied to laboratories over time, the history of ISO/IEC 17025, and details of the QMS proposed by the newest version of this document, published in 2017.

Definition of quality

In daily life, the search for products and services that fulfil customers’ expectations is always ongoing. As such, the topic of quality is noticeable and any absence of quality is readily perceived. Quality impacts the success of organizations and the lives of every person in a positive manner. Despite being easily identified, perceptions of quality do not rely on a clear definition of what quality is. [2]

Several authors have attempted to define quality. Berhe and Gidey [3], for example, state that the quality of a product is the capacity of such product to meet expectations from both the market and the customer. Quality has also been defined in the perspective of services. Once that service is not a physical matter and, to a certain extent, is intangible, quality has, in this context, two approaches to be assessed: technical quality, which is expressed as the results delivered to the customer, and functional quality, which is expressed as the quality of processes that the customer had to undergo to reach the result. [2]

Such study about the concepts of quality and their development are useful to define "quality management" more precisely, establishing it as a field of knowledge with its own line of research. Quality management is considered a management system which seeks improvement for products and processes by using the organization’s own knowledge and resources. Its main objectives are satisfying customer requirements and meeting their expectations. [4]

Quality in laboratories

Just like other organizations, a laboratory must be concerned with satisfying customers and their expectations by delivering both reliable results and good customer service. Additionally, it must work to assure the quality of its services. [4]

Such concern is shown by Staats [5], who declares that, in analytical chemistry, it is not enough just being able to analyze information in order to be of recognized quality. In this case, quality assurance is unavoidable in a high-level, complex market. The author also stresses the importance of a quality system which can assure suitable information management, the latter contributing to the reliability and traceability of data.

Christelsohn and Meyer [6] state how the laboratory’s concern for its customers is important and stress that QMSs are important tools for achieving such a goal. The researchers analyzed the advantages and disadvantages regarding the prevailing norms and pointed out the need for a robust QMS which places more emphasis on the customer, guided by the ISO 9001 standard. They also mentioned one of ISO/IEC 17025's predecessor documents, DS/EN 45001, responsible for providing criteria for measuring the technical competence of a laboratory. In such a way, the laboratory’s need to assure the quality of its services to its customers is noticeable, regarding both the reliability of its results and the quality of its customer service, thus making the development and implementation of a QMS very appealing.

According to Olivares [4], a QMS is defined as systems put in place seeking to ensure products with the same characteristics and services are delivered in a standardized form, in turn ensuring customers’ interests and meeting their expectations. For laboratories, one of the main sources for QMS development and implementation is the ISO/IEC 17025 standard, which was developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

ISO/IEC 17025, whose history shall be detailed further in this work, has been adopted by many laboratories worldwide. Conclusions have since been drawn after sufficient laboratories fully adopted the QMS proposed by the norm, as seen in the work of Dizadji and Anklam. [7 10.1007/s00769-003-0659-z] Regarding the adoption of ISO/IEC 17025:1999, Dizadji and Anklam [7] clearly cited the advantages of doing so, such as increased reliability of the laboratory's work, better efficiency and efficacy, improved market opportunities, and greater competitive advantage in comparison to competitors. The authors also stressed the importance of following the proposed QMS to prove the laboratory capable of delivering its services. They also defined "competence" as the laboratory’s capacity to yield reliable results and to meet customers’ needs.

The concerns with quality assurance and the analytical laboratory's requirement to have quality control in order to yield reliable results are pointed out by Masson. [8] The author mentions the existence of texts which foresee the construction of quality systems, i.e., ISO/IEC 17025. Nevertheless, the author also clearly states that the laboratory should know its own routine and must adjust to the requirements of such systems, which can be adopted and customized to the laboratory's needs.

Concerns about specific conditions written in ISO/IEC 17025 can be noticed in works related to the quality assurance of results provided by laboratories, such as the discussion about total error and measurement uncertainty by Rozet et al. [9] Another perspective was introduced by Konieczka et al. [10], who point out the necessity for improved focus on sampling recommendations, to avoid errors related to the uncertainty estimation of the aforementioned process.

Lastly, in accordance with the trends of normative texts published by international bodies, Wong [11] highlights the union of the laboratory’s risk management to the QMS. It aims to create action plans, which in turn allows labs to better handle risks and opportunities.

ISO/IEC 17025

As mentioned, the ISO/IEC 17025 standard proposes the enactment of a QMS for laboratories which wish to show their competence, and this standard has been adopted by many laboratories around the world. [1] Currently, ISO/IEC 17025 is on its third version as an actual standard, with its origin found in various ISO "guides" in the last decades of the previous century. ISO Guide 25: Guidelines for assessing the technical competence of testing laboratories is considered the first document related to the norm in its current version. This document was issued by the International Laboratory Accreditation Cooperation (ILAC) on October 1, 1978. [12] ILAC is an international cooperation, whose members are accreditation bodies for laboratories using the most current standards and guidelines, with representatives in more than 70 countries. This cooperation started in October 1977, seeking to develop international cooperation towards improving the laboratory market by promoting acceptance of accredited test and calibration results. [13]

ISO Guide 25 did not address calibration laboratories, only testing laboratories. In the document, there were general guidelines towards helping laboratories prove their technical competences. Though initially inadequate, the guide allowed evaluation bodies to ask for other requirements other than the ones already stated in the guide’s text. [12] The requirements stated in ISO Guide 25 touched upon the organization, its staff, their protection, testing and measuring equipment, calibration, test methods and procedures, the work environment, safety, handling of items to be tested, records management, and test reports. [12]

ISO Guide 25 was replaced by ISO/IEC Guide 25 General requirements for the technical competence of testing laboratories on December 12, 1982. For the first time, the document presented itself as both an ISO- and IEC-driven document. [12] The ISO is an independent, non-governmental, international organization, made of members from 162 countries. It was created in 1947 to ease international coordination and to unify industrial standardization. Nowadays, it has 784 technical committees and subcommittees responsible for the development of international standards. [14] The IEC, created in 1906, is a worldwide organization that creates and publishes international standards in the areas of electrical, electronic, and related technologies. When plausible, both organizations unite to assure the construction of international standards, which are complementary to each other due to the collaboration between correlated professionals. [15]

While an improvement, ISO/IEC Guide 25 still only addressed testing laboratories, though mentioning in the “Scope and field of application” section that it could also be used by accreditation and certification bodies, as well as governmental and non-governmental bodies, related to the technical competence of laboratories. [15] The document addressed the same issues addressed in its predecessor [12], though it must be noted that, when comparing it with ISO Guide 25, the quality system requirement was added to ISO/IEC Guide 25.

International guides only addressed testing laboratories until, in 1990, ISO/IEC Guide 25: General requirements for the competence of calibration and testing laboratories was published. [12] This updated highlighted the efforts of ISO/CASCO to publish documents that allow laboratory certification to be made based on internationally established documents. The Council Committee on Conformity Assessment (CASCO) is responsible for the document's issuance, gained by consensus from the Committee itself and supported by the ISO and IEC councils. The purpose of such efforts was to provide support for national systems, thus easing bilateral agreements. [12]

Notes

This presentation is faithful to the original, with only a few minor changes to presentation. Grammer was tweaked significantly to improve readability. The PMCID and DOI were also added when they were missing from the original reference.