ISO/IEC 17025: history and introduction of concepts

Abstract

Quality is an increasingly present concept nowadays, so meeting the customers’ needs, who buy and use products and hire services, becomes essential. For laboratories, the concept is applied to the reliability and traceability of the results produced and presents itself not only to meet the customer’s needs, but also to allow the signing of agreements in the international trade. The concept of Quality in a laboratory can be carried out from the elaboration of a Quality Management System (QMS). To this end, the normative document ISO/IEC 17025, internationally accepted, has been changing over the years aimed at instructing the elaboration of a management system which 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 and the 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 norm history and its most recent changes. Its intent is support laboratories whose objective is to implement a QMS according to this normative reference

Full text

Quim. Nova, Vol. XY, No. 00, 1-5, 200_ http://dx.doi.org/10.21577/0100-4042.20170726
*e-mail: annaluisarmiguel@gmail.com
ISO/IEC 17025: HISTORY AND INTRODUCTION OF CONCEPTS
Anna Luísa Ribeiro Miguela,*,, Renata Pereira Lopes Moreiraa and André Fernando de Oliveiraa
aDepartamento de Química, Universidade Federal de Viçosa, 36570-000 Viçosa – MG, Brasil
Recebido em 26/11/2020; aceito em 02/02/2021; publicado na web em 24/02/2021
Quality is an increasingly present concept nowadays, so meeting the customers’ needs, who buy and use products and hire services,
becomes essential. For laboratories, the concept is applied to the reliability and traceability of the results produced and presents itself
not only to meet the customer’s needs, but also to allow the signing of agreements in the international trade. The concept of Quality in
a laboratory can be carried out from the elaboration of a Quality Management System (QMS). To this end, the normative document
ISO/IEC 17025, internationally accepted, has been changing over the years aimed at instructing the elaboration of a management
system which 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 and the 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 norm history and its most recent changes. Its intent is
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 often important decisions are based
on these. According to the great responsibility of these laboratories,
being able to assure the quality of their service and the reliability
of the reported results is important. In order to demonstrate their
competence, laboratories through-out the world use the document
ISO/IEC 17025. This document proposes a Quality Management
System (QMS) that ensure the quality control and metrological
traceability. Besides, this document facilitates access to world markets
and provides domestic and international socio-economic benets.1
For the sake of making the knowledge about ISO/IEC 17025
increasingly more accessible, this article presents the concept of
Quality, this concept applied to laboratories over time, the ISO/IEC
17025 history and the QMS proposed by the new version of this
document, published in 2017.
Denition of Quality
On daily life, the search for products and services that full the
customers’ expectations is always present. In this way, the presence
of Quality is noticeable, and its absence, readily perceived. Quality
impacts the success of organizations and the lives of every person
in a positive manner. Despite being easily identied, perceptions on
Quality do not rely on a clear denition of what quality is.2
Several authors have been working on the concept of Quality.
For illustrative purposes, Berhe and Gidey3 states that the quality
of a product is the capacity of such product to meet expectations
from both market and customer. Quality has also been dened 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 expresses
the results delivered to the customer, and functional Quality, which
expresses the quality of processes that the customers had to undergo
to reach the result.2
Such study about the concepts of Quality and their development
are useful to dene what Quality Management more precisely is,
establishing it as a eld 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
self-knowledge. Its main objectives are satisfying the customers and
meeting their expectations.4
Quality in laboratories
Just like other organizations, a laboratory must be concerned in
satisfying customers and their expectations by delivering both reliable
results and a 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 analyse 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 for reliability and
traceability of data.
On the same topic, Christelsohn and Meyer6 state how the
laboratory’s concern for its customers is important and stress that
quality management systems are important tools for achieving such
goal. The researchers analysed the advantages and disadvantages
regarding the prevailing norms and pointed out a robust Quality
Management System (QMS) which emphasized more on the
customer, the ISO 9001. They also mentioned the norm EN 45001,
responsible for proving 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 customer service, thus making the origin of a QMS
concept very appealing.
According to Olivares,4 QMS is dened as systems put in place
seeking to make sure products with the same characteristics and
services be delivered in a standardized form, thus ensuring the
customers’ interests and meeting their expectations. For laboratories,
one of the main QMS is the norm ISO/IEC 17025, which was
Assuntos Gerais

Miguel et al.
2Quim. Nova
developed by the ISO (International Organization for Standardization)
and by IEC (International Electrotechnical Commission).
The norm ISO/IEC 17025, whose history shall be detailed further
on the text, was adopted by many laboratories worldwide. Since then,
conclusions were drawn after the adoption of the QMS proposed by
the norm, as seen in the work of Dizadji e Anklam.7
Regarding the adoption of the norm ISO/IEC 17025:1999,
Dizadji e Anklam7 clearly cited the advantages of doing so, such as
increased reliability of the laboratory, better efciency and efcacy,
new market opportunities and 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 dened competence as the laboratory’s capacity
to yield reliable results and to meet the customers’ needs.
The concern with quality assurance and the analytical
laboratories’ 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. norm 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 by laboratories
with different characteristics.
Concerns about specic conditions written in the norm 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 done by Rozet et al.9 Another
perspective was introduced by Bodnar, Namieśni e Konieczka,10
who pointed out the necessity for better attention regarding
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, Wong11 highlights the union of
the laboratory’s risk management to the quality management system.
It aims to create action plans, these intended to handle risks and
opportunities.
ISO/IEC 17025
As mentioned, the ISO/IEC 17025 norm proposes the enactment
of a QMS for laboratories which wish to show their competence, thus
being adopted by many laboratories around the globe.1
Currently, the norm is on its third version as an actual norm, and its
origin comes from documents issued as Guides in the last decades of
the previous century. The document titled “ISOGuide25: Guidelines
for assessing the technical competence of testing laboratories”
is considered the rst document related to the norm in its current
version. This document was issued by ILAC (International Laboratory
Accreditation Cooperation) on October 1st 1978.12
ILAC is an international cooperation, whose members are
accreditation bodies for laboratories according to the current norms,
with representatives in more than 70 countries. This cooperation
started in October 1977, seeking to develop international cooperations,
turning market easier by promoting acceptance of accredited test and
calibration results.13
The ISO Guide 25 did not address calibration laboratories, only
testing laboratories. In the document, there were general guidelines
so the laboratories could prove their technical competences. Still, the
Guide allowed the evaluation bodies to ask for other requirements
other than the ones already stated in the Guide’s text.12
The requirements stated in the ISO Guide 25 were: organization,
staff, protection, testing and measuring equipment, calibration, test
methods and procedures, environment, safety, handling of items to
be tested, records and test reports.12
Such guide was replaced by the “ISO/IEC Guide 25: General
requirements for the technical competence of testing laboratories”,
in December 12th 1982. The document presented itself as both
an ISO (International Organization for Standardization) and IEC
(International Electrotechnical Commission) 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 on 1906, is a worldwide organization that creates
and publishes international standards in the electrotechnical area.
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
The ISO/IEC Guide 25 still used to address only testing
laboratories and mentioned, in the “Scope and eld of application”
topic, that it could be used by accreditation and certication bodies,
governmental and non-governmental bodies related to the technical
competence of laboratories.15
The requirements stated in the previous document were:
organization, quality system, staff, testing and measuring equipment,
calibration, test methods and procedures, environment, safety,
handling of items to be tested, records and test reports.12 It must be
noticed that, when comparing it with ISO Guide 25, the quality system
requirement was added.
As mentioned, at the time, international guides only involved
testing laboratories until, in 1990, the “ISO/IEC Guide 25: General
requirements for the competence of calibration and testing
laboratories” was published.12
This version of the ISO Guide 25 shows the effort from ISO/
CASCO to publish documents that allow laboratory certication to
be made based on internationally established documents. The CASCO
(Council Committee on Conformity Assessment) is responsible for
the documents’ issuance, gained by consensus from the Committee
itself supported by the ISO and IEC Councils. The purpose of such
efforts is to provide support for national systems, thus easing bilateral
agreements.12
The requirements stated in this version of the ISO Guide 25 were:
organization and management, quality system, audit and critical
analysis, staff/personnel, facilities and environment, equipment
and reference material, measurement and calibration traceabilities,
calibration and test methods, handling of the calibration and test items,
records and certicates and reports.12 The Guide also emphasized that
by meeting these criteria, the laboratories would meet the criteria of
the ISO 9000 norm.12
The ISO Guide 25 was the last written version of this document as
a Guide, even though, according to Van de Leemput,16 it had already
been written in the norm format by using vocabulary like “shall” and
“must” instead of “should” and “may”. This document was replaced
on 1999 by the norm “ISO/IEC 17025: General requirements for the
competence of testing and calibration laboratories”.
A revision request sent to ISO, on 1993, made by the European
Technical Committee on Conformity Assessment after the Guide’s
failure to replace the prevailing European document on technical
competence and laboratory accreditation. On 1994, CASCO decided
in favour to revise the Guide after a meeting with the stakeholders.16
In order to successfully revise the Guide, the main principle was
that the new document should allow laboratories to display their
competence, whether they were interested in accreditation or not.
Despite the new principle, only the revised Guide’s requirements
were used as criteria for accreditation.16

ISO/IEC 17025: history and introduction of concepts 3Vol. XY, No. 00
The revision process took around 6 years, when drafts were
written, discussed and voted on. During the process, it was decided
that, if IEC approved the document, its prex would be ISO/IEC. On
November 1999, the document got 95% approval rate, being published
on December 15th 1999.16
Also during the process, it was agreed that the revised document’s
relation with ISO 9001 should be clear, with no ambiguity, and its
text should cover all aspects of ISO 9001. With this provision, a
laboratory which met ISO/IEC 17025 requirements would meet the
ISO 9001 requirements too.16
It was decided that the new document’s requirements would be
divided in two categories: management requirements and technical
requirements. The ISO/IEC 17025:1999 was divided as follows:
1. Objective; 2. Normative References; 3. Terms and denitions;
4.Management requirements; 5. Technical requirements; Annex A;
Annex B; References.
The requirements of item 4, management requirements, addressed
the following topics: organization (4.1); quality system (4.2);
document control (4.3); review of requests, tenders and contracts
(4.4); subcontracting of tests and calibration (4.5); service and
supply purchase (4.6); customers’ service (4.7); complaints (4.8);
non-compliant tests and/or calibration work control (4.9); corrective
action (4.10); preventive action (4.11); record control (4.12); internal
audits (4.13); review by management (4.14).
The requirements of item 5, technical requirements, addressed the
following topics: general (5.1); staff (5.2); facility and environmental
conditions (5.3); test and calibration methods and method validation
(5.4); equipment (5.5); metrological traceability (5.6); sampling (5.7);
handling of test and calibration items (5.8); quality assurance of tests
and calibration results (5.9); reporting of results (5.10).
According to Van de Leemput,16 ISO 9001 norm was also under
revision and the publication of its new version was due in 2000.
Nevertheless, the ISO/IEC 17025 was issued in 1999 based on the
ISO 9001 norm of 1994. Even though the latter norm would be
outdated in a short time, the ISO/IEC 17025 was published in 1999
due to the large demand for it and the illogicality of being based on
an unnished, future norm.
Therefore, on May 2005, the new version of ISO/IEC 17025 was
published, and it t the revision of the ISO 9001 norm, published in
2000. There are no fundamental differences between the 1999 and
2005 version of the norm. Some of the differences are: highlighting of
the continuous improvement of the quality management system; more
emphasis on establishing effective communication with the customer;
use of data to assess the performance of the quality management
system and to identify improvement opportunities.17
The 2005 version had the following division: 1. Objective;
2.Normative references; 3. Terms and denitions; 4. Management
board requirements; 5. Technical requirements; Annex A; Annex B;
References.
The requirements of item 4, management board requirements,
addressed the following topics: organization (4.1); management
system (4.2); document control (4.3); review of requests, tenders
and contracts (4.4); subcontracting of tests and calibrations (4.5);
service and supply acquisition (4.6); customer service (4.7);
complaints(4.8); non-compliant test and/or calibration work
control(4.9); improvement(4.10); corrective action (4.11); preventive
action (4.12); record control (4.13); internal audits (4.14); review by
management board (4.15).
The requirements of item 5, technical requirements, addressed
the following topics: general (5.1); personnel (5.2); facility and
environmental conditions (5.3); test and calibration methods and
method validation (5.4); equipment (5.5); metrological traceability
(5.6); sampling (5.7); handling of test and calibration items (5.8);
quality assurance of test and calibration results (5.9); reporting of
results (5.10).
On the 2005 version of the document, it is possible to notice
that the management requirements are assigned to the management
board instead to the managers. Due to the focusing of the continuous
improvement of the QMS, the topic “Improvement” was added to the
management requirements (item 4).
A new version of the ISO/IEC 17025 was issued on 2017 in
order to update and align it to other current norms, including the
ISO 9001. To this purpose, the new version included requirements
for competency, impartiality, and consistent laboratory operation.18
The new document has a different structure compared to the
older version, and it is not divided into management requirements
and technical requirements. The 2017 version is divided as follows: 1.
Scope; 2. Normative references; 3. Terms and denitions; 4. General
requirements; 5. Structural requirements; 6. Resource requirements;
7. Process requirements; 8. Management system requirements; Annex
A; Annex B; References/bibliography.
The newest version is more process-focused instead of the
older procedural focus, decreasing the number of required policies
and procedures. The Quality Manual is now optional, letting the
laboratory decide to establish it or not. The division between technical
management and quality management was replaced by the laboratory
general responsibility management.18
In General requirements, the norm stablishes specic requirements
for impartiality and for condentiality, stressing their importance, in
consideration that they are not restricted to the laboratory policies.
This version also emphasizes risk management, pointing out the need
for risk identication in many of the norm’s requirements.18
The development of the document in all its version and
publications are displayed on Table 1.
ISO/IEC 17025:2017
As previously mentioned, the new version of ISO/IEC 17025,
published in 2017, was required to update and align the document
to current versions of other norms, including ISO 9001. So, in this
intent, it is possible to point out some main differences between the
previous version (2005) and the updated version (2017).
The 2017 version presents a denition for “Laboratory”, in which
it is dened as a body that performs at least one of the three activities
Table 1. History of the norm ISO/IEC 17025
Version Year Type Document name
First 1978 Guide ISO Guide 25: Guidelines for assessing the technical competence of testing laboratories
Second 1982 Guide ISO/IEC Guide 25: General requirements for the technical competence of testing laboratories
Third 1990 Guide ISO/IEC Guide 25: General requirements for the competence of calibration and testing laboratories
Fourth 1999 Norm ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
Fifth 2005 Norm ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
Sixth 2017 Norm ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories

Miguel et al.
4Quim. Nova
that are presented as “laboratory activity”: testing, calibration and
sampling followed by testing or calibration (3.6). It is noticeable that
sampling is presented as a laboratory activity.19,20
The concepts of impartiality and independency are differentiated
(3.1), and the requirements about impartiality (4.1) and condentiality
(4.2) must be aligned with ISO/CASCO orientation.19,20 Furthermore,
the risk-based thinking is implemented, in alignment with the ISO
9001 new version (2015). This proposes the monitoring of risks
associated with impartiality and laboratories activities. It is suggested
classifying the appointed risks according to seriousness and tracking
them with the intention of maintaining them under control (8.5).19,20
The term “decision rule” is introduced and it states that the
laboratory has to dene and apply some criteria in order to decide
if the obtained result fullls the requirements, in view to attend the
client’s demands (7.1.3).19,20
Requirements now focus on the outcome, ensuring quality work
and validity of result, which provides more exibility to laboratories.
Besides, the requirements deal with the processes of laboratory
activities, looking for a consistent approach on the process and
oriented, in the document, by the necessity of documentation of
the laboratory’s requirements, retention of records and effective
communication with people and organizations affected.19,20
This new version has put attention in the technology advance,
considering electronic management of data and information (7.11).20
Lastly, the document was restructured, and the requirements are now
organized in different sections: according to the content division of the
2017 norm, the obligatory requirements for laboratories are described
in the sections: 4. General requirements; 5. Structural requirements; 6.
Resource requirements; 7. Process requirements, and 8. Management
system requirements.
The requirements are grouped based on their characteristics.
It can be visualized on Figure 1 how they correlate to each other
to create a QMS, which has the purpose to meet all proposed
requirements. Therefore, Figure 1 is a graphic representation of ISO/
IEC 17025:2017, with the objective of making the norm’s requirement
groups easier to understand.
The requirements which belong to Section 5, Structural
requirements, address the aspects that make the laboratory capable of
doing its activities, the latter being considered the base of the QMS.
On Figure 1, the laboratory structure is represented in a way that it
encompasses all requirements left. The next group to be represented
is Section 4, General requirements, which addresses impartiality
and condentiality in the development of the laboratories’ activities,
setting up the risk to impartiality management in a continuous manner.
On Figure 1, this section is located with the structural requirements
group.
After the denition of the QMS basic parts, the management
processes are represented. They guide and encompass all laboratory
activities developed by the laboratory. These processes are represented
in lilac, are separated in four blocks, and encircle the remaining
requirements. These processes must be executed in the same manner
for all tests addressed by the QMS, while other requirements might be
specic depending on the laboratory activity. Most of these processes
are requirements of Section 8, Management requirements, and include
some requirements of Section 7, Process requirements.
Inside the representation of the management processes are the
processes directly related to the execution of laboratory activities,
that may be specic. The Figure 1 represents a laboratory whose
activities are restricted to tests only, excluding sampling activities.
The processes represented by blue correspond to the Section 6
requirements, Resource requirements, and the processes in yellow
correspond to the Section 7, Process requirements. These processes
are placed in order to clarify how both resource and process
requirements correlate to each other.
In order to compare the 2017 version with the previous one
(2005), it can be stated that the management requirements, previously
categorised in section 4, are now reorganised within sections 4, 5 and
8; and the technical requirements, previously categorised in section
5, are now reorganised within sections 6 and 7.
Given all the main changes between the 2005 and 2017 versions
mentioned above, it is concluded that the new version of the norm
proposes a more efcient management system, reducing the number
of mandatory procedures and not requiring a quality manual, but
focuses on consistent processes, with personnel able to perform them
and maintain objective evidence of activities duly recorded. This new
proposition may help laboratories to create and implement a QMS
consistent with its own reality, according to the size of the personnel
of each laboratory and the activity it develops (calibration or testing
in multiple areas, such as environment, forensics, food and others).
Also, the risk management is proposed to help laboratories assure
the quality of its activities once the risk to laboratory activities and
impartiality are now duly monitored and treated.
Figure 1. Graphic representation of ISO/IEC 17025:2017

ISO/IEC 17025: history and introduction of concepts 5Vol. XY, No. 00
In addition, this new version highlights the importance of meeting
the customer demands through the adoption of a decision rule to
report a nal result. Focusing on the importance of the measurement
provided by the laboratory to the customers’ interests, this position
reinforces the importance of laboratories to provide reliable and
traceable results to support the decision making in different situations.
In this way, ISO/IEC 17025 proposes a QMS through the
requirements established and mentioned above to prove the technical
competence and ensure the quality of the results produced by the
laboratory. The use of this document can be presented as a tool
to assist the implementation of the Quality concept in testing and
calibration laboratories.
CONCLUSIONS
Since the service provided by testing and calibration laboratories,
the measurement results, is largely used to support decision making
with social impact, these laboratories must be aware of tools to ensure
quality control, and reliable results and apply them in daily activities.
As shown, the QMS proposed for ISO/IEC 17025 contributes to the
establishment of a routine based on quality assurance. Therefore,
testing and calibration laboratories must be responsible with
their activities and its impacts, and put quality management and
metrological traceability in place.
ACKNOWLEDGMENTS
The authors are grateful to the Brazilian Agency for nancial
support: Coordenação de Aperfeiçoamento de Pessoal de Nível
Superior (CAPES), Conselho Nacional de Desenvolvimento
Cientíco e Tecnológico (CNPq) and Fundação de Amparo à Pesquisa
do Estado de Minas Gerais (FAPEMIG).
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