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International Journal of Quality & Reliability Management

ISO 9001 and ISO/IEC 17025: Which is the best option for a laboratory of
metrology? The Portuguese experience
José Barradas, Paulo Sampaio,
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José Barradas, Paulo Sampaio, (2017) "ISO 9001 and ISO/IEC 17025: Which is the best option for
a laboratory of metrology? The Portuguese experience", International Journal of Quality & Reliability
Management, Vol. 34 Issue: 3, pp.406-417, https://doi.org/10.1108/IJQRM-03-2014-0032
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IJQRM QUALITY PAPER


34,3
ISO 9001 and ISO/IEC 17025
Which is the best option for a laboratory of
406 metrology? The Portuguese experience
José Barradas
Received 11 March 2014
Revised 10 February 2015
CATIM – Technological Centre for Metal Industry, Porto, Portugal, and
6 August 2015
Accepted 1 September 2015
Paulo Sampaio
Department of Production and Systems, University of Minho, Braga, Portugal

Abstract
Purpose – According to the ISO 9001 standard, all the certified companies should calibrate their measuring
equipment. By doing so, companies can guarantee, with rigor and quality, its measurement and use reliable
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data for monitoring the quality of their products. However, a metrology laboratory is not required to have an
ISO 9001 certification or ISO/IEC 17025 accreditation. At this moment, there are companies with their quality
management systems certified according to the ISO 9001 standard which have metrology laboratories to
make internal checks of their measuring equipment. On the other hand, there are companies with ISO/IEC
17025-accredited laboratories. Finally, there are companies that have their QMS certified according to ISO
9001 and also their metrology laboratory accredited by ISO/IEC 17025. In this case the metrology laboratory
must comply with the requirements of both standards. Thus, the purpose of this paper is to analyze the level
of importance of the ISO 9001 and ISO/IEC 17025 standards from the perspective of a metrology laboratory.
Design/methodology/approach – The research methodology used to conduct this research was supported
in case studies that had been carried out in nine metrology laboratories. The information was gathered based
on semi-structured interviews.
Findings – After an analysis and discussion over the data obtained, the authors verified that the impact on
customer perception is significantly positive, if the metrology laboratory is simultaneous certified and
accredited.
Originality/value – From the laboratories perspective, the issue analyzed in this paper is of the utmost
importance and the aim is to give the contribution in order to clarify this kind of organizations of which could
be the best option for their context.
Keywords ISO 9001, Metrology, Accreditation, Certification, ISO/IEC 17025
Paper type Research paper

1. Introduction
One of the differentiating factors in organizations for success in an increasingly globalized
market is undoubtedly the certification. According to Santos (1992), certification ISO 9001 aims
to provide a proof that organizations have the capacity to comply with certain requirements
and requirements recognized at European level and even internationally. Moreover, the
certification demonstrates easily the validity of its own quality management system (QMS) to
customers, thereby being at the forefront in possible tenders and contracts for the supply of
services or products. According to Peña (2002), the ISO 9001 registration is a guarantee that all
the measuring and control equipment is calibrated or verified, or both. In doing so, companies
ensure with accuracy and quality their measurements and use reliable data to monitor the
quality of their products and improvements (Barradas and Sampaio, 2011).
Management systems certification and accreditation are activities that differ in terms of
objectives and standards. According to the ISO/IEC 17000 standard, certification
International Journal of Quality &
Reliability Management (management systems, products and people) is a conformity assessment activity. On the
Vol. 34 No. 3, 2017
pp. 406-417
other hand, accreditation is the recognition of the technical competence to carry out
© Emerald Publishing Limited conformity assessment activities. If a laboratory is certified according to the ISO 9001
0265-671X
DOI 10.1108/IJQRM-03-2014-0032 standard, there is a guarantee that calibration or tests are conducted in accordance with
written procedures and the requirements stated by the standard. By the other side, the ISO 9001 and
accreditation according to the ISO/IEC 17025 standard goes beyond the execution of ISO/IEC 17025
calibration according to a written procedure and required for a confirmation of technical
competence of who performs the calibration activity (Duarte, 2007). Currently, there are
certified or accredited laboratories according, respectively, to the ISO 9001 standard and
ISO/IEC 17025 standard and also laboratories that have implemented both standards.
Therefore, the aim of this study is to analyze the importance level of the ISO 9001 and 407
ISO/IEC 17025 standards for a metrology laboratory.
Given the fact that the majority of the research conducted so far in this area does not
address which are the main motivations of the metrology laboratories when they decide to
implement one or two standards, our goal is to analyze the level of importance of both
standards based on the laboratory perspective, mainly to identify the laboratories’
motivations for the management system implementation, the difficulties related to the
implementation process and how these difficulties were overcome and the benefits derived
from that implementation. In order to answer this question, case studies were carried out in
laboratories that have the three possible hypotheses, i.e. laboratories certified according to
the ISO 9001 standard, laboratories accredited by the ISO/IEC 17025 standard and
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laboratories that have implemented a management system according to both the standards.
Metrology and quality are two very important areas for industry and society and that
cannot exist one without the other.
This papers aims to present the benefits of having a QMS certified according to the ISO
9001 and/or accredited according to ISO/IEC 17025 one.

2. Literature review
The implementation of a management system is always a voluntary act that could be
carried out by any organization. According to Jongen (1998), depending on the purpose of
the organization, the management system implemented should be the one that is more
appropriated, focusing the continuous improvement and the customer satisfaction.
The management systems certification and accreditation cause some misunderstanding
at the companies’ level, because the real meaning of them is unknown. According to the ISO/
IEC 17000 standard, certification is the “third part attestation related to products, processes,
systems or persons.” In other words, certification is a conformity assessment activity carried
out by an independent third-party organization, in order to verify if the requirements
defined in the standard are fulfilled. According to Guerreiro (2001), the certification means
that an organization is required to work according to certain standards.
The certification according to the ISO 9001 standard results in clear benefits for
organizations and society in general. The ISO 9001 certification ensures the effective
realization of the services or products. The implementation of the ISO 9001 standard
enables the continuous improvement of the QMS, contributing to increase customer
satisfaction. By this way, customers have valid reasons to demand that the final product
or service has a high level of quality, since the organization is not only concerned in the
execution of tasks, but also in management, planning and control requirements as
requested by the customer (Fonseca, 2002). Being able to access new markets is also an
advantage of the certification according to the ISO 9001 standard. Another added value to
a laboratory and according to Prieto (2008) is a greater work organization and motivation
of all employees toward continuous improvement, and to foster communication between
all levels of management and employees themselves. According to Dick et al. (2002),
organizations that have a quality certification give more emphasis on quality than those
who do not have, since they recognize quality as an important contribution to the
performance of their business. Thus, a QMS can play a very positive role, promoting the
companies competitiveness.
IJQRM In 2005 was published the second edition of the ISO/IEC 17025 standard, which defined
34,3 the general requirements that a laboratory must meet to be registered.
The implementation of this standard is applicable to all laboratories independently of the
number of employees or the extension of the scope of testing and/or calibration activities.
The definition of accreditation according to the ISO/IEC 17000 standard is a “third part
attestation, related to a conformity assessment body, which is a formal recognition of their
408 competence to perform specific activities of conformity assessment,” i.e. the accreditation is
recognition of the technical competence to carry out conformity assessment activities.
According to the standard, “the conformity of the quality management system of a
laboratory with the requirements of ISO 9001 does not prove by itself the competence of the
laboratory to produce technically valid data and results. Additionally, the implementation of
the standard does not mean the compliance of the quality management system of the
laboratory with all the requirements defined in the ISO 9001 one.” Thus, and according to
Jongen (1998), one of the benefits of the ISO/IEC 17025 accreditation is to promote the
co-operation between laboratories and other organizations, collaborating in the exchange of
information and experiences and in the harmonization and standardization of procedures
and standards. The accreditation of a laboratory further increases the organization’s
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performance through a better control of laboratory procedures, thus improving its potential
due to increase customer satisfaction.
According to Jongen (1998), Squirrell (2001) and Nara (2003), the most important
accreditation benefit is that any test or calibration certificate issued by an accredited
laboratory signatory of the Mutual Recognition Agreement (MRA) is accepted in any
signatory country of the agreement.
Based on Pritzkow (2003), the ISO/IEC 17025 standard includes the requirements of ISO
9001 standard that are relevant to the service or calibration tests. According to Jongen
(1998) and Pizzolato et al. (2008), depending on the laboratory business, the laboratory could
audit its QMS according to the ISO 9001 or the ISO/IEC 17025 standards.
In a laboratory that is accredited according to the ISO/IEC 17025 standard there is not a
guarantee that it fulfills all the ISO 9001 requirements, including those that cover the
requirements related to product realization and monitoring (Barradas and Sampaio, 2011).
However, for a laboratory that has a QMS implemented according to the ISO 9001 standard
there is not a guarantee that it has the technical competence to perform test, inspection or
calibration activities. The ISO 9001 certification only recognizes that the organization has a
formal recognition of its QMSs and is theoretically more concerned with the conformity of
the products or services according to customer requirements (Dick et al., 2002).
The QMS requirements are an important issue for an ISO/IEC 17025-accredited
laboratory. However, the main goal the ISO/IEC 17015 standard is focused on the technical
competence and technical resources availability to get accurate and reliable data. In other
perspective, an ISO 9001 certification ensures the compliance of the organization with the
requirements defined for a QMS (Drake, 2003) and not the technical competence required by
the ISO/IEC 17025 standard. Additionally, there are differences on the purpose, criteria and
relevance when both standards are compared, but also a high degree of complementarities.
Therefore, the decision of a laboratory to become accredited according to the ISO/IEC 17025
standard or certified according to the ISO 9001 one, or both, will depend on the overall needs
of each laboratory and expectations of its customers, regulators or other interested parts on
the laboratory technique or specific conformity ( Jongen, 1998; Drake, 2003).

3. Research methodology
This research was based on case studies that had been carried out in nine metrology
laboratories. The data were gathered based on semi-structured interviews. According to
Pawson (1996) and Houtkoop-Steenstra (1996), this type of method enables to obtain
qualitative data through open questions and provides an “environment” more relaxed to the ISO 9001 and
interviewee, allowing the same to answer the questions in their own words and present some ISO/IEC 17025
ideas and opinions. This methodology allows to gather facts, opinions, goals, plans and
ideas that would be difficult to investigate and analyze by other methods such as filling out
questionnaires (Macnealy, 1997). According to Mintzberg (Eisenhardt, 1989), “no matter
how much our sample is small or what is our interest, we always try to enter in
organizations with a objective well-defined to collect an specific data.” 409
Nine case studies had been conducted, based on three different groups of laboratories:
laboratories with ISO 9001 certification (group ISO 9001), laboratories with ISO/IEC 17025
accreditation (group ISO/IEC 17025) and laboratories with ISO 9001 certification and
ISO/IEC 17025 (group ISO 9001 and 17025). The interviews were performed with the
manager of the laboratory QMS.
The laboratories analyzed activity sectors were training centers, civil construction, ceramics
industry, gas equipment industry, technological centers and automotive industry. Furthermore
the laboratories were also from different geographic areas – they were located in Central and
Northern Portugal and also one laboratory in Spain, located in the region of Galicia.
With the information gathered in the interviews, it was possible to make a more detailed
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characterization of the sample of this research work. Thus, the three ISO 9001 laboratories
are of a private nature; one of the laboratories has ten employees and the two others have
three employees each. Concerning the ISO/IEC 17025 group, two of the laboratories are of
public nature; one of them has 14 employees and the others have 20 employees. The third
laboratory of this group has four employees and is of private nature. In the ISO 9001 and
ISO/IEC 17025 group, one of the laboratories is of private nature and has 30 employees.
Concerning the other two, they are of private nature, non-profit and of public interest and
they have, respectively, 20 and 25 employees each.
Based on the literature review carried out, there are several studies about the benefits of
implementing the ISO 9001 and ISO/IEC 17025 standards. However, they are mostly focus
on individual standards implementations and not from an integrated perspective. Thus, this
study research questions are the following ones:
RQ1. Which are the main motivations for a metrology laboratory implement the ISO
9001 or/and ISO/IEC 17025 standards?
RQ2. Which are the most important difficulties related to the implementation process?
RQ3. What is the impact of an ISO 9001 and/or ISO/IEC 17025 management system
implementations in a metrology laboratory?
RQ4. Are there any substantial differences between the implementation of one or both
standards in a metrology laboratory?

4. Results: analysis and discussion


For an easier interpretation of the results, in the following sections the laboratories will be
designated by:
• Lab.C1, Lab.C2 e Lab.C3 (ISO 9001 group);
• Lab.A1, Lab.A2 e Lab.A3 (ISO/IEC 17025 group); and
• Lab.CA1, Lab.CA2 e Lab.CA3 (ISO 9001 and 17025 group).

4.1 Difficulties related to the implementation process


The most important difficulties pointed out by the companies concerning the management
system implementation were the development of processes and procedures, the definition
IJQRM of acceptance criteria for the equipment, the lack of training in the area of metrology
34,3 and the implementation of new ways of work, different than the ones used in the past
by the laboratories.
The difficulties related to the management of the equipment and the calculations of the
uncertainties were only stated by the groups ISO/IEC 17025 and ISO 9001 and 17025 (Table I).
By the analysis of Table I, it is clear that the main difficulties in a metrology laboratory
410 during the management system implementation process are transversal to all systems and
groups. Only the difficulties related to the management of the equipment and calculation of
uncertainties are discussed in the groups that have the accreditation according to the
ISO/IEC 17025 standard.

4.2 Why the certification and/or accreditation are important?


The reasons that lead laboratories to apply for certification, accreditation or both are
different. In the case of the ISO 9001 group, the main reason that leads the laboratories to
implement the ISO 9001 standard is the fact that they belong to a company that has its QMS
implemented according to the ISO 9001 standard. A company that wants to improve its
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internal working methods and focus on product quality or customer service has more
propensity to have a metrology laboratory to perform internal calibrations of its measuring
equipment. The activity sector requirement, such as the automotive industry, is another
important reason that leads the laboratory to reach the ISO 9001 certification.
Concerning accreditation, the main reason why some laboratories use only this recognition is
related to market requirements. On the other hand, there are laboratories that have applied to
ISO/IEC 17025 accreditation in order to perform calibrations to their external customers and to
get the recognition of the metrology services in any country signatory of the MRA/EA (European
Co-operation for Accreditation) and International Laboratory Accreditation Co-operation.
Concerning those laboratories that are both certified and accredited, the main reasons for
certification/accreditation were to standardize all the procedures of the laboratory and to
improve the recognition of the metrology services in any country signatory of the MRA.
Table II compiles the major motivations for laboratories to certify their management systems.

Group ISO 9001 Group ISO/IEC 17025 Group ISO 9001 and 17025

Development of processes and procedures


Table I. Definition of acceptance criteria for the equipment
Difficulties during the Lack of training in the metrology area
management system Implementation of new ways of work
implementation Difficulties related to the management of equipment
process Calculations of the uncertainties

Group ISO 9001 Group ISO/IEC 17025 Group ISO 9001 and 17025

Improve their internal working Market requirement Recognition of the metrology


methods and focus on product services in any country signatory to
quality or customer service the MRA of the EA and ILAC
Make internal calibrations to their Perform calibrations, to their Standardize all the areas of the
Table II. measuring equipment external customers laboratory
Certification and/or The activity sector requirement Recognition of the metrology Greater recognition of the quality of
accreditation (such as the automotive industry) services in any country signatory service provided to the customer
motivations of the MRA/EA and ILAC
By the analysis of the responses found in Table II, it appears that there is no specific ISO 9001 and
motivation to implement a management system according to the ISO 9001 standard in a ISO/IEC 17025
metrology laboratory. The laboratory is ISO 9001 certified just because the organization to
which the laboratory belongs has a management system certified according to that
standard. Organizations that are committed to quality and wish to perform internal
calibrations and checks have a metrology laboratory, which is regarded as a department
within the organization. Concerning the laboratories with a management system 411
implemented according to the ISO/IEC 17025 standard, the most important motivation to
get ISO/IEC 17025 accreditation is related to market requirements. Laboratories from the
group ISO 9001 and 17025 recognize that the main motivations that lead them to have both
standards implemented are the standardization of all laboratory areas and to promote a
greater reputation of quality customer service.

4.3 Certification and accreditation benefits


For the ISO 9001 group, the certification of the laboratory brought out a greater
systematization of all the information process and activities. People became more involved
and more proactive. There was also a better training and more information for employees.
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The requirement to calibrate and check the measuring equipment is another important
benefit to laboratories, as they carry out in-house services, because the measuring
equipment are crucial in the continuous improvement of products. One of the studied
laboratories stated that: “with the calibration/verification of the measuring equipment, we
learn that the equipment are in proper working order.” One will only have high-quality
products if the equipment used to control them have the minimum of rigor.
In the case of the laboratories accredited by the ISO/IEC 17025 standard, the
organizational benefits are the possibility of traceability of all the work performed and of all
the equipment, and also the operational definition of the laboratory, which means that the
results are reliable and credible. In this case, there is an important benefit that is the higher
training level for people who are working in the laboratory. Another major benefit that is the
enlargement of the number of customers and the workload for the laboratories, because the
customers require accredited calibrations.
Concerning the third studied group, certified and accredited laboratories, the opinions are
not consensual concerning the benefits. Initially, the laboratories mentioned the benefits of each
standard separately. The differences emerged after questioned about the benefits of having
both standards. Some of them said that the ISO 9001 is not useful for a laboratory that has its
management system accredited by the ISO/IEC 17025 standard. By the other side, others
argued that the integration of both standards is useful for the laboratory, since one of the
benefits achieved was the increase in equipment life. Another major benefit pointed out was the
improvement of customers’ perception of the quality of the service provided by the laboratory.
This perception is due to the fact that a considerable part does not know the real difference
between certification and accreditation. Table III compiles the benefits identified in each group.

4.4 Certification and accreditation costs


The analysis of the certification and accreditation costs is a very important issue from the
laboratories perspective. For the ISO 9001 group, all the investment related to the QMS
implementation would not have been worthwhile if it was only for the laboratory, but as the
laboratory is one important issue that contributes to a better quality of the product or
service, the company’s investment was well done. Furthermore, the laboratories pointed out
that the cost with the management of the equipment is very high. However, this cost is not
understood as an expense but as a requirement for high-quality products and services.
The ISO/IEC 17025 laboratories pointed out that the investment needed to fulfill all the
requirements for accreditation are very high when compared to the price that is charged to
IJQRM Group ISO 9001 Group ISO/IEC 17025 Group ISO 9001 and 17025
34,3
Greater systematization of all Possibility of traceability of all Increase of the equipment life
the information and activities the work and all the
equipment
Better training and Higher training level for the The technicians had more specific training in
information for people technicians the areas of metrology and quality
412 The people become more Reliable and credible of the Improvement of customer’s perception of the
involved and more proactive results quality of the service provided by the
laboratory
Table III. The requirement to calibrate/ Increased number of
Certification and check the measuring customers
accreditation benefits equipment

the customer. However, all the laboratories had stated that the balance is very positive,
because the customer satisfaction also improved.
Those laboratories that have implemented both standards reported high certification and
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accreditation costs. The investment related to the implementation of both standards


increases workload and gives a greater credibility when compared to other laboratories.
The costs are lower when compared to the accreditation ones (Table IV).

4.5 Why do not implement the ISO/IEC 17025 standard?


The most common reasons stated for why the laboratories do not implement the ISO/IEC
17025 standard were:
• high internal costs; and
• not intend to perform external services.
According to the analyzed laboratories, the internal costs related to the maintenance of the
system are usually high. Additionally, accreditation would only make sense if the
laboratories want to “sell” the calibration services to the market. At this point, we are able to
conclude that those laboratories certified according to the ISO 9001 standard do not intend
to apply for the accreditation according to ISO/IEC 17025, due to the fact that they only
provide internal services. As previously mentioned an accreditation according to the
ISO/IEC 17025 standard increases the organization internal costs.
Additionally, the ISO/IEC 17025-accredited laboratories stated that they do not
intend to have the certification according to the ISO 9001 standard because it is not an

Group ISO 9001 Group ISO/IEC 17025 Group ISO 9001 and 17025

The investment related to the QMS The investments, they must have to The costs with the registration and
implementation would not have been fulfill the requirements for renewal processes with the
worthwhile if it was only for the accreditation, are very high accreditation process are very high
laboratory, but as the laboratory is compared to the cost they charge
one of the links in the quality of the by the service to the customer
product or service, the company’s
investment was well done
The cost with the management of Balance of the investment in the The investment related to the
equipment is very high, but is an accreditation is very positive, implementation of both standards,
Table IV. requirement for product quality because the customer satisfaction increases workload and gives a
Certification and and customer service also improves greater credibility when compared
accreditation costs to others laboratories
added value to the laboratory, and because the customers just require an accredited ISO 9001 and
report/certificate and do not asked if the company or laboratory has a certified ISO/IEC 17025
management system.

4.6 ISO 9001 certification and ISO/IEC 17025 accreditation, it makes sense?
In this group the answers were more comprehensive. One of the most important reasons that
lead the laboratories to have both standards implemented is the higher competence of the 413
technicians to deliver a service. With the implementation of the two standards, the
technicians have a higher perception of the impact that a non-conforming work has in
the quality of products and services provided to the customers. The position of the
laboratories in the market and the improvement in the standardization of procedures,
processes and documents was a positive result in this group of laboratories.

5. Conclusions, research limitations and future work


The main objective of this research project was to analyze and identify the reasons why a
metrology laboratory implements a management system according to the ISO 9001
standard or based on the ISO/IEC 17025 standard or both.
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Based on the analysis performed, it was found that there is not a specific reason for a
metrology laboratory that becomes certified according to the ISO 9001 standard. Usually,
this takes place only when the laboratory is in an ISO 9001-certified organization and its
main business is to perform internal calibrations or internal verifications.
For an ISO/IEC 17025-accredited laboratory, the main reasons to become accredited are
related to technical competence, recognition to perform external services and market and
customers issues. For these laboratories, the ISO 9001 certification would not add any value
to the customer service and would be an additional cost to the laboratory.
The laboratories that are simultaneously ISO 9001 certified and ISO/IEC 17025
accredited have more benefits. The main benefits pointed out were the fact of their
technicians are properly trained and so the laboratories perform high-quality services for
external customers. In this way, they realize the impact of their service has on the final
quality of products and services provided to the customers.
The main difficulties pointed out by the laboratories in the implementation of
the standards were the development of processes and procedures, the definition of the
equipment acceptance criteria, the lack of employee training in metrology issues and
the implementation, modification and adaptation of new ways of work. Difficulties related
to equipment management and to calculation of the uncertainties were only identified in
laboratories that have implemented a management system according to the ISO/IEC
17025 standard.
Concerning the impact of the ISO 9001 and ISO/IEC 17025 standards, individually or in
an integrated perspective, apparently the ISO 9001 implementation promotes a higher
systematization of the information and a greater involvement of the employees in the
laboratory activities, as well as an increase in the effectiveness of employees’ training and an
improvement of the calibration processes performance. In laboratories that adopted an
integrated approach, the main impact was verified at the level of customer satisfaction,
concerning the perceived quality of the service.
The ISO 9001-certified laboratories provide services mainly for internal customers while
the ISO/IEC 17025-accredited laboratories provide mostly services for external customers.
Thus, we can state that accreditation according to the ISO/IEC 17025 standards is an
important recognition for the metrology laboratory.
Based on the case studies performed, one were able to conclude that there is a high
level of complementarities between the ISO 9001 standard and the ISO/IEC 17025 one,
despite the differences of each standard scope. Therefore, the laboratory decision to become
IJQRM certified or accredited or both will depend on the overall needs of each laboratory and
34,3 expectations of its customers or regulators. For those laboratories that are committed to
demonstrate technical competence supported by a QMS, the appropriate standard is the
ISO/IEC 17025 one. In addition, if a laboratory is focused to get a higher recognition
concerning the service provided, it should implement, based on an integrated perspective,
the ISO 9001 standard.
414 Given that this research had been supported in a small number of case studies, the
conclusions here presented reflect the reality of the analyzed laboratories. However, in our
opinion, the conclusions reached out would not change if it was performed a large number of
case studies.
With this work we intended to call attention and interest to the area of metrology and its
importance to the quality of goods and services that all organizations want to achieve by
end. Thus, this research can be seen as a “launching pad” for future research related to the
importance of the ISO 9001 and ISO/IEC 17025 standards to metrology laboratories, in a
globalized and competitive world.

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Further reading
ISO 9001 (2008), “Quality management systems – requirements”. 415
ISO/IEC 17000 (2005), “Conformity assessment – vocabulary and general principles”.
ISO/IEC 17025 (2005), “General requirements for the competence of testing and calibration
laboratories”.

(The Appendix follows overleaf.)


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IJQRM Appendix
34,3

ISO 9001 standard ISO/IEC 17025 standard

4 Quality management system 4 Management requirements


416 4.1 General requirements 4.1 Organization
4.2 Documentation requirements 4.2 Management system
4.2.1 General 4.2 Management system
4.2 Management system
4.3 Document control
4.3.1 General
4.2.2 Quality manual 4.2 Management system
4.2.3 Control of documents 4.3 Document control
4.2.4 Control of records 4.13 Control of records
5 Management responsibility
5.1 Management commitment 4.2 Management system
4.15 Management reviews
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5.2 Customer focus 4.4 Review of requests, tenders and contracts


5.3 Quality policy 4.2 Management system
5.4 Planning 4.2 Management system
5.4.1 Quality objectives 4.2 Management system
5.4.2 Quality management system planning 4.2 Management system
5.5 Responsibility, authority and communication 4.1 Organization
4.2 Management system
5.5.1 Responsibility and authority 4.1 Organization
5.5.2 Management representative 4.1 Organization
5.5.3 Internal communication 4.1 Organization
5.6 Management review 4.15 Management reviews
6 Resource management
6.1 Provision of resources 4.4 Review of requests, tenders and contracts
4.7 Service to the customer
5.4 Test and calibration methods and method
validation
6.2 Human resources 5.2 Personnel
6.2.1 General
6.2.2 Competence, training and awareness 5.2 Personnel
6.3 Infrastructure 5.3 Accommodation and environmental conditions
5.4.7 Control of data
5.5 Equipment
5.6 Measurement traceability
6.4 Work environment 5.3 Accommodation and environmental conditions
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the 4.4 Review of requests, tenders and contracts
product
5.4 Test and calibration methods and method
validation
7.2.3 Customer communication 4.4 Review of requests, tenders and contracts
4.7 Service to the customer
Table AI. 4.8 Complaints
Comparative analysis 7.3 Design and development
of the references 7.4 Purchasing 4.6 Purchasing services and supplies
between ISO 9001
standard and ISO/IEC
17025 standard (continued )
ISO 9001 standard ISO/IEC 17025 standard
ISO 9001 and
ISO/IEC 17025
7.5 Production and service provision
7.5.1 Control of production and service provision 5.2 Personnel
5.4 Test and calibration methods and method
validation
5.5 Equipment
5.6 Measurement traceability 417
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration
results
5.10 Reporting the results
7.5.2 Validation of processes for production and 5.2 Personnel
service provision
5.4.2 Selection of methods
5.4.5 Validation of methods
7.5.3 Identification and traceability 5.8 Handling of test and calibration items
7.5.4 Customer property 4.1 Organization
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5.8 Handling of test and calibration items


7.5.5 Preservation of product 4.6 Purchasing services and supplies
7.6 Control of monitoring and measuring equipment 5.4 Test and calibration methods and method
validation
5.5 Equipment
5.6 Measurement traceability
8 Measurement, analysis and improvement
8.1 General 4.10 Improvement
5.4 Test and calibration methods and method
validation
5.9 Assuring the quality of test and calibration
results
8.2 Monitoring and measurement 4.10 Improvement
8.2.1 Customer satisfaction 4.7 Service to the customer
8.2.2 Internal audit 4.14 Internal audits
8.2.3 Monitoring and measurement of processes 4.11 Corrective action
4.14 Internal audits
5.9 Assuring the quality of test and calibration
results
8.2.4 Monitoring and measurement of product
8.3 Control of non-conforming product 4.9 Control of non-conforming testing and/or
calibration work
8.4 Analysis of data 4.10 Improvement
5.9 Assuring the quality of test and calibration
results
8.5.1 Continual improvement 4.10 Improvement
4.12 Preventive action
8.5.2 Corrective action 4.11 Corrective action
8.5.3 Preventive action 4.12 Preventive action Table AI.

Corresponding author
Paulo Sampaio can be contacted at: paulosampaio@dps.uminho.pt

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