Introduction

Since the mutual recognition agreement sponsored by the International Laboratory Accreditation Cooperation—ILAC MRA, was put in place in 2000 [1], the number of signatories has more than doubled, totalizing 100 accreditation bodies of 103 economies in December 2018 [2]. Following the same trend, since 2008 the number of laboratories accredited worldwide, according to ISO/IEC 17025 [3], has increased 70 %, ending 2018 with over 58000 testing laboratories and 11000 calibration laboratories [2]. This growth is mainly due to the increase in international trade and the need to meet regulatory agency requirements, especially in the areas of environment, health and food safety.

According to 2018 data, 96 % of global gross domestic product (GDP) is covered by ILAC MRA Signatories [4]. The importance of accreditation and accredited services to the economic and social context of countries has been demonstrated through several case studies and research papers [4, 5], covering different sectors and countries.

Accredited laboratories are from different institutions, such as national or multinational organizations. Some of these are in Higher Education Institutions (HEI) and Research Institutes (RI), which seek accreditation as a competitive advantage and a way to qualify their activities. In this sense, the main benefits obtained from accreditation, mentioned by HEI laboratories in a survey carried out on the American Continent [6], also reported in the literature [7,8,9,10,11], were reliability of results and qualification of personnel. Both findings are consistent with the fact that HEI focus essentially on researching and teaching, and they value these issues. The increased income was mentioned in the third place in that survey.

Despite the benefits, obtaining and maintaining accreditation by HEI and RI laboratories face specific challenges often derived from the complex and wide-ranging nature of research activities and have raised several studies [5, 9,10,11,12,13]. The percentage of accredited HEI and RI labs is still low, generally speaking, according to the survey previously mentioned [5].

The aim of this paper is to present the current landscape of accreditation for testing and calibration laboratories, according to ISO/IEC 17025 standard [3], in Europe, and to compare with data obtained on the American Continent. The laboratories accredited by the signatory bodies of ILAC MRA [1] were classified by institution type, according to their activities, as HEI, RI and other institutions as general organizations and commercial laboratories. Relationships of the total number of accredited laboratories with the GDP and with the population in each country were investigated. The identification of countries with the highest percentages of accredited HEI laboratories and the identification of these laboratories will be used as a basis for future work, searching for actions and/or strategies that encourage HEI laboratories to seek accreditation. Due to similarities in characteristics and activities, they may also be used by RI laboratories.

Methodology

Laboratories accredited according to the ISO/IEC 17025 standard were identified through a search in websites of accreditation bodies signatories to the ILAC MRA [1], in the European Union (EU) countries. Other countries of the European Continent were not included in the study due to the need to limit its scope. Data were collected from June to September 2019. The laboratories were grouped by country, and only considered if they were accredited by the national accrediting body in their own country. Institution and laboratory were recorded separately. Multiple laboratories were counted per institution, whenever they were part of different units of the same institution, or when they had different managers. The institutions and laboratories were classified in three categories according to their activities, as described in Table 1. The Pearson correlation coefficient was employed to correlate the country population with the GDP, and multiple regression analysis was employed to assess the effect of the independent variables population and GDP per capita on the number of accredited laboratories, using the software Excel. The independent variables X were normalized.

Table 1 Category of institutions and laboratories according to their activities
Full size table

Results and discussion

Three EU countries were excluded from this study as they do not have local accreditation bodies signatories to the ILAC MRA [1] so far. Data are presented according to the number of accredited institution and laboratories per country and correlated with the GDP and population. The number of laboratories by type of institution was also considered and analyzed.

Relationships between the total number of accredited laboratories, the gross domestic product (GDP) and the population

The total number of the institutions with accredited laboratories and the number of accredited laboratories per country, the GDP and population of the country are shown in Table 2. GDP and population figures presented here were truncated, without rounding. In all countries investigated, there are more laboratories than institutions because some institutions have more than one accredited laboratory. Several institutions were identified with both accredited testing and calibration laboratories, mainly manufacturers of measuring equipment and instruments, inspection and testing centers or institutes with extensive service portfolios, often in the fields of energy and electro-electronics. These two facts had also been noticed in the previous research [5].

Table 2 Number of accredited institutions and laboratories, gross domestic product (GDP of 2018) [19] and population [20] per country
Full size table

Several multinational groups have a large number of accredited laboratories. Those include Eurofins, a world leader in product testing in the food, environment, pharmaceutical and other fields, found in 20 out of the 25 countries, which has more than 30 accredited laboratories in France, Germany and Finland; more than 20 in the UK and Sweden, and more than 10 in the Netherlands and Denmark. The Trescal group, a global player in the field of metrology and management of test and measurement instruments in various areas, is found in 11 countries, with more than 20 accredited testing and calibration laboratories in the UK and France; 14 in Germany and 10 in Italy. SGS is another multinational company in the field of inspection and tests, with laboratories in 16 countries, with more than 20 accredited laboratories in the UK, Germany, France and Sweden.

Other situations with a large number of laboratories per institution are those related to regulated areas in the EU. Accreditation is an EU requirement for testing laboratories involved in Official Food Control [14], as well as in monitoring water intended for human consumption [15]. For example, the Regional Directorate for the Environment, Planning and Housing (Direction Régionale de l’Environnement, de l’Aménagement et du Logement—DREAL) in France has 16 accredited laboratories. In Italy, there are more than 60 accredited laboratories from the Regional Agency for the Protection of the Environment (Agenzia Regionale per la Protezione Ambientale—ARPA). In the Czech Republic, 37 accredited test and calibration laboratories are involved in water and sewage treatment. The Water Supply and Sewerage Enterprise (Przedsiębiorstwo Wodociągów i Kanalizacji), in Poland, has 25 accredited laboratories and the District Sanitary-Epidemiological Station (Powiatowa Stacja Sanitarno-Epidemiologiczna), 85, to monitor quality and other hygiene and health requirements related to environment and food. Greece has more than 50 accredited laboratories connected to the Ministry of Rural Development and Food (Υπουργείο Αγροτικής Ανάπτυξης και Τροφίμων), and in Italy, more than 90 were found at the Experimental Zooprophylactic Institute (Istituto Zooprofilattico Sperimentale), operating at the National Health Service in the area of Veterinary Hygiene and Public Health, some of them also conducting research.

In addition to these areas, more than 50 forensic accredited laboratories were observed in the UK, 30 in Romania and 19 in the Czech Republic. In Spain, the Criminal Service of the Civil Guard (Servicio de Criminalística de la Guardia Civil—SECRIM) has accredited laboratories in 47 cities and the General Committee of Scientific Police (Comisaría General de Polícia Científica) in 22. Other EU countries have also accredited laboratories in this field, in order to improve the mutual exchange of information in forensic science [16], required by the European Network of Forensic Science Institutes—ENFSI [17], or comply with country-specific laws or rules.

Although the recommended standard for clinical laboratories is ISO 15189 [18], many ISO/IEC 17025 accredited laboratories have been found in the area of human health, in hospitals and medical clinics.

The known inequality between the EU and the American Continent and between American Continent countries can be observed in Table 3. Although the total GDP of the EU is about 30 % smaller than the American Continent total GDP, its mean GDP per capita is almost 3 times higher. About 25 % of the EU countries surveyed presented GDP of less than $ 100 billion of US dollars, while on the American Continent, almost half of the countries were in that situation [5]. Moreover, the gap in GDP between the richest and the poorest countries on each continent is almost 100 times higher on the American Continent. Although the American continent has a population 1/3 larger and 3 countries with more than 100 million inhabitants, population data are not so different between both regions. The interesting fact is that the economic inequality is reflected in the total and per capita number of accredited laboratories in each region, as well as in the number of accredited laboratories in their countries.

Table 3 Comparison between EU and American Continent
Full size table

An upward trend in the number of accredited laboratories was observed with the increase in the country’s population and/or GDP, as shown in Fig. 1. The number of accredited laboratories in some countries seems to deviate from the expected pattern shown by GDP or population, as Poland and Czech Republic. One hypothesis states that in these countries, there are many laboratories in areas such as environment, human and animal health. In these situations, the number of laboratories is related to regulatory issues rather than commercial, with no impact on GDP.

Fig. 1
figure 1

Number of total accredited laboratories, GDP and population per country

Full size image

To reduce the effect of the strong positive correlation between population and GDP (r = 0.93), the GDP per capita was used as the independent variable related to economic aspect in a multiple regression analysis. As expected, a significant effect of the population on the number of accredited laboratories (R2 = 0.93; p < 0.01) was observed in EU countries. However, there was not enough evidence to state that GDP per capita has a statistically significant effect (p = 0.32). On the other hand, on the American Continent both the population and the GDP per capita presented significant effects on the number of accredited laboratories (R2 = 0.92; p < 0.01 and p = 0.03, respectively). Despite these results, the economic effect when comparing both regions is undeniable. The EU, with a smaller population and a lower total GDP, has twice the number of accredited laboratories and almost three times higher the GDP per capita.

Number of laboratories by type of institution

The percentage of accredited laboratories by type of institution (HEI, RI and OI), based on total number of laboratories per country, in the 25 EU countries surveyed, is shown in Fig. 2. As observed in the countries of the American Continent, EU countries also differ in these proportions.

Fig. 2
figure 2

Percentage of accredited laboratories by type of institution (HEI, RI and OI—see Table 1), based on total number of laboratories per country

Full size image

Some HEI with large number of accredited laboratories are presented in Table 4. In general, those correspond to large and old institutions, most of them public and technically oriented. Additionally, other HEI in several countries have more than one accredited laboratory. HEI with more than 10 accredited laboratories had been identified in only a few countries of the Americas, such as Mexico, Costa Rica, Chile and Colombia [5].

Table 4 Average number of HEI accredited laboratories per institution, name and foundation date of HEI institutions with several accredited laboratories per country
Full size table

HEI accredited laboratories from university hospitals, medical universities or faculties were found in 21 out of the countries studied. In France, 2/3 of HEI accredited laboratories provide public health services, organized in regional university hospital centers (Centre Hospitalier Régional Universitaire—CHRU). Several of them were originated from small hospitals created in the fifteenth and sixteenth centuries, and nowadays, they have a triple mission: assistance, teaching and research.

Quality management systems at higher levels of HEI were also observed. For example, the Polytechnic University of Milan Quality Center, through the University Quality Service (Servizio Qualità di Ateneo—SQuA), is part of the central administration and serves various university structures for ISO/IEC 17025 accreditation and ISO 9001 certification. The Quality Management Department of the Materials Testing Institute from Stuttgart University supports the institution’s accreditation of meeting ISO/IEC 17025, ISO/IEC 17065 and ISO/IEC 17020 standards. Likewise, the TU Graz internal quality management system provides support to the Institute of Technology and Testing of Construction Materials (Institut für Materialprüfung und Baustofftechnologie—TVFA), also accredited to ISO/IEC 17025, ISO/IEC 17065 and ISO/IEC 17020. At the University of Liège, the RQLab is open to all university services, regardless of their field of activity or the quality approach intended (accreditation or certification).

Several RI also have a high number of accredited laboratories, such as the Fraunhofer Institutes in Germany and the RISE Research Institutes of Sweden Holding (RISE) in Sweden, both with 30 laboratories. In Spain, the Esteban Terradas National Technical Aerospace Institute (Instituto Nacional de Técnica Aerospacial Esteban Terrasas—INTA) has 11 accredited laboratories.

RI accredited laboratories were also observed in regulated areas, most of them public, such as the Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH—AGES), with 17 laboratories; the State General Laboratory (Γενικό Χημείο του Κράτους—ΓΧΚ) in Cyprus, with 20 laboratories; the French Agency for Food, Environmental and Occupational Health & Safety (L’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail—ANSES), with 21 laboratories; and the National Laboratory of Health, Environment and Food (Nacionalni laboratorij za zdravje, okolje in hrano—NLZOH) in Slovenia, with 11 laboratories. Additionally, there are several RI with accredited laboratories in the sectors of energy and civil engineering, among others.

During the study, it was noted that only a few laboratories are already accredited according to the current version of ISO/IEC 17025, probably due to its launch in late 2017 and the need for translation into different languages. Full adaptation to this version is expected to occur by the end of 2020.

Conclusions

This paper presents and comments on the current landscape of laboratory accreditation, from the point of view of testing and calibration laboratories under ISO/IEC 17025 [3], in the European countries that are part of the EU. Many institutions in most countries surveyed have several accredited laboratories, some of them multinational groups, operating in many EU countries. An upward trend in the number of accredited laboratories was observed with the increase in the country’s population and/or GDP. It was also possible to notice a strong regulation in the areas of human and animal health and safety, and environmental, which seems higher than observed on the American Continent. However, this finding may be related to the gap between the two surveys (2016 and 2019), although GDP and population had an increase of 10 % and 4 %, respectively, between 2014 and 2018 on the American Continent.

Even for different regions, America and Europe, several similar characteristics were observed, at least for the 25 countries included in this study. However, a smaller disparity was observed between EU countries than observed on the American Continent, perhaps due to their greater geographical and cultural proximity. The EU, with a smaller population and a lower total GDP, has twice the number of accredited laboratories and almost three times higher the GDP per capita. Additionally, the number of HEI with more than 10 accredited laboratories was higher, perhaps due to the fact that HEI in Europe are larger and older.

Further studies through surveys in HEI laboratories, as have been done on the American Continent [6], may provide a better understanding of their characteristics and difficulties. Identification of strategies and new ideas could favor implementation of quality management systems and accreditation of HEI and RI laboratories.