ISO 9001 or ISO 17025 : what is more important for the metrology laboratory

Full text

12. me unarodni Simpozij o kvaliteti
„KVALITETOM DO POSLOVNE IZVRSNOSTI“, 17.-18.03.2011.
309
ISO 9001 OR ISO 17025: WHAT IS MORE IMPORTANT
FOR THE METROLOGY LABORATORY
ISO 9001 ILI ISO 17025: KOJA JE VAŽNIJA ZA MJERNE LABORATORIJE
José Barradas
CATIM – technological center for metal industry
E-mail: josbarradas@gmail.com
Paulo Sampaio, PhD
Systems and Production Department
University of Minho, Portugal
E-mail: paulosampaio@dps.uminho.pt
UDK: 005.6:006.91
Pregledni rad/Review
Primljeno: 18. prosinca, 2010./Received: December 18th, 2010
Prihva!eno: 04. velja"e, 2011./Accepted: February 4th, 2011
ABSTRACT
In the last decade, the number of Portuguese companies with quality certiÞ cation
has increased, as is the case in most countries. According to the ISO 9001 standard
all the certiÞ ed companies should calibrate their measuring equipment. By doing so,
companies can guarantee, with rigor and quality, its measurement and use reliable data
for monitoring the quality of its products and its improvement. However, a metrology
laboratory is not required to hold an ISO 9001 certiÞ cation or ISO 17025 accreditation.
In this moment, there are companies that have metrology laboratories to conduct an
internal check of their measuring equipment. These companies have their quality
management systems (QMS) certiÞ ed according to the ISO 9001 standard and so all
its departments and sub-departments must also comply with the requirements of this
standard. On the other hand there are companies with ISO 17025 accredited laboratories.
Usually these companies are independent and his metrology laboratory is essentially to
perform the calibration service to national companies who use their services to make the
calibration of its measuring devices. These labs can be inserted into a company which
does not have their QMS certiÞ ed by any national or international standard. Finally,

310
there are companies that have their QMS certiÞ ed to ISO 9001 and also its metrology
laboratory accredited by ISO 17025. In this case the metrology lab must comply with
the requirements of both standards. Thus, the aim of the research project is to analyze,
in Portugal, the importance level of ISO 9001 and ISO 17025 standards for a metrology
laboratory to reach the quality.
Key words: ISO 9001, ISO 17025, certiÞ cation, accreditation, Quality
Management Systems, metrology.
1. INTRODU CTION
The ISO 9001 management systems certiÞ cation is one of the most
important issues for the success of the Portuguese companies in the globalized
market. According to Santos (1992), the ISO 9001 is a guarantee that the
certiÞ ed Þ rms have the capacity to comply with some requirements recognized
at a worldwide level. Furthermore this certiÞ cation demonstrates more easily
the validity of its Quality Management System (QMS) for his own customers,
getting in the front line in possible contracts for the provision of services or
products. According to Peña (2002), ISO 9001 registration is a guarantee that
all the measuring and control equipment is calibrated or veriÞ ed, or both, at
speciÞ ed intervals in metrology laboratories, whose measurement standards
used are traceable to international measurement standards or national, according
to section 7.6 of the standard ISO 9001. Thus ensuring, with rigor and quality,
their measurements and the use of reliable data for monitoring the quality of
their services or products and their improvement (Karnes and Kanet, 1994), and
in many cases, provide considerable savings with services or non-compliant
products. Concerning the Portuguese reality, the majority of the laboratories are
accredited by the Portuguese Institute for Accreditation (IPAC), according to the
ISO 17025 standard.
The management systems certiÞ cation and accreditation differ with
respect to the aim and standard. According to the ISO 17000 standard, certiÞ cation
(management systems, products, and people) is one of conformity assessment
activities. On the other hand, accreditation is the recognition of technical
competence to carry out conformity assessment activities, according to the same
standard.
According to Prado Filho (2010), if a laboratory has been certiÞ ed
according to the ISO 9001 standard there is a guarantee that calibration or tests
are conducted in accordance with written procedures and grounds to ensure the
requirements of the standard concerned. By the other side, the accreditation
according to the ISO 17025 standard goes beyond the execution of calibration
according to a written procedure and required for a conÞ rmation of technical
competence of who performs the proper calibration (Duarte, 2007).

311
However, a metrology laboratory is not required to have a ISO 9001
certiÞ cation or ISO 17025 accreditation. According to Noronha and Magalhães
(2006) these recognitions are essential requirements for the laboratory
differentiation in the market.
Main research question of this project is to analyse what it is the most
important standard for a metrology laboratory, if only one of the standards (ISO
9001 or ISO 17025) or if both.
2. LITERATURE REVIEW
According to the ISO 17000 standard, certiÞ cation is a “third party
attestation for products, processes, systems or persons”. Guerreiro (2001) stated
that a certiÞ ed company is required to work with rigorous and speciÞ c standards.
2.1. ISO 9001 certiÞ cation
The certiÞ cation according to the ISO 9001 standard produces clear
beneÞ ts for companies and for the society. For the society it ensures that the
services or products that we buy respect some standards and thus it could be
faced as deciding factor for the purchase. For companies, the implementation of
ISO 9001 standard enables continuous improvement of their quality management
systems and contributes to the increase of the customer satisfaction (Fonseca,
2002). The access to new markets is also an important ISO 9001 beneÞ t, since
certiÞ cation is an international guarantee of the organizational management.
According to Prieto (2008), for a metrology laboratory, the ISO 9001 standard
promotes a better organization of the work and the motivation of all employees
towards continuous improvement and even improves the communication between
all levels of management and their own workers. According to Sampaio et al.
(2009), the ISO 9001 beneÞ ts could be classiÞ ed as internal and external ones. In
Table 1 are listed the most common ISO 9001 beneÞ ts.

312
Table 1. ISO 9001 most common beneÞ ts (Sampaio et al. 2009)
External beneÞ ts Internal beneÞ ts
- Access to new markets.
- Improving the company image.
- Increased market share.
- Marketing tool.
- Improved customer relationship.
- Increased customer satisfaction.
- Improved communication with
the customer.
- Productivity increases.
- Decrease the percentage of non-conforming.
- Greater awareness of the concept of quality.
- ClariÞ cation of responsibilities and obligations.
- Improvements in delivery times.
- Improved internal organizational.
- Reduction of non-conformities.
- Decrease the number of complaints.
- Improvements in internal communication.
- Improvements in product quality.
- Competitive Advantages.
- Motivated employees.
- Decreased levels of scrap.
According to Dick et al. (2001), it appears that companies that have
quality certiÞ cation gives more importance to quality than the remaining ones
and thy recognize quality as an important contribution to business performance.
2.2. ISO 17025 accreditation
The deÞ nition of accreditation according to the ISO 17000 standard is
the “third party attestation, related to a conformity assessment body, which is a
formal recognition of their competence to perform speciÞ c activities of conformity
assessment.”
One of the most important beneÞ ts of accreditation according to the ISO
17025 standard is to endorse the cooperation and partnership between laboratories
and other institutions with the aim of exchanging information promoting the
harmonization and standardization of procedures and standards. According
to Ramjun (2009), a laboratory accreditation strengthens the organization
performance through a better control of laboratory procedures and thereby
increases their potential due to the increase customer satisfaction.
Accreditation is also an effective marketing tool for calibration or for
testing, because it is a “passport” for companies and organizations that require
reliable and independent laboratories. One of the most important ISO 17025
beneÞ ts is to reduce the number of audits and evaluations by customers, since it
is periodically audited by an accreditation body. Additionally, according to Nara
(2003) and Sousa (2008), one important accreditation beneÞ t is that any test or
calibration certiÞ cate issued by an accredited laboratory that is a signatory of the
Mutual Recognition Agreement (MRA), is accepted in any country signatory of
the Agreement.

313
2.3. ISO 9001 and ISO 17025: different or complementary?
According to Pizzolato et al. (2008), depending on the laboratory
business, the laboratory could assess its QMS according to ISO 9001 or ISO
17015 standard.
According to the ISO 17025 standard, the conformity of the quality
management system with the requirements of ISO 9001 does not prove, by itself,
the competence of the laboratory to produce technically valid data and results.
A laboratory that is accredited according to the ISO 17025 standard does not
guarantee the fulÞ lment of all ISO 9001 requirements. By the other side, an ISO
9001 certiÞ ed laboratory could not have enough technical competence to assess
conformity of certain equipment, products or services or people. According
to Dick et al. (2002), ISO 9001 standards is concerned mainly with what the
laboratory does to ensure the compliance of their products or services according
to customer requirements. In Figure 2 illustrates the interaction between ISO
9001 and ISO 17025.
Figure 1. Interaction between ISO 9001 and ISO 17025 standards
ISO 17025
ISO 9001
Increased focus
on product
requirements and
implementation
requirements for
monitoring and
evaluation processes.
Common
requirements
Technical
competence
requirements
As is illustrated in Figure 2, there are some important differences
between the two standards, because ISO 17025 does not meet all the ISO 9001
requirements, mainly those related to product requirements and implementation
requirements for monitoring and evaluate processes.
Those laboratories that are interested in demonstrate technical competence
should adopt the ISO 17025 standard. Moreover, those laboratories that are already
accredited by the ISO 17025 standard and that are embedded in organizations
that also carry out activities such as accounting, marketing, consulting, training
and other, should evolve to an ISO 9001 quality management system.

314
2.4. Metrology
The word metrology can be divided into two parts: metro + logy. The word
meter is related to measure something and the word logy is related to the science
of something. Thus, Metrology is the science of measurement. The deÞ nition
of metrology according to the International Vocabulary Metrology (2008) is the
“science of measurement and their applications.”
Metrology is used by all. All comparisons between what we believe is
hotter or colder, longer or shorter, etc. For example when we left to the street
in the winter, we said: “It is colder here than in the house.” In this case we
compare the temperature inside the house (our reference value) with the outside
temperature (measured value), and so what we do is a calibration, but without
its element of uncertainty. Now, it is really much colder? Is the difference so
great? Metrology responds exactly to these issues and ensures, with a certain
uncertainty, if what we are measuring is really correct.
As already mentioned by Bunday et al. (2007), when we measured
something, the error and uncertainty is always present and can never be totally
eliminated. That is the reason why we use weights and measures in order to
minimize the error and its measurement uncertainty. The metrology laboratories
and the calibration laboratories have that role.
The minimization of measurement errors and manufacturing defects are
crucial to a company because it can make the difference between a high quality
product and a product of low quality (Bunday et al., 2007). Metrology was
initially used to monitor the product.
Also in our day-to-day, metrology is important because we use many
measuring equipment. Metrology is an important activity for business development
and also for the society development (Martínez-Sánchez et al., 2009 and Santos
and Mainier, 2010).
3. RESEARCH METHODOLOGY
The research project here present in this paper will be supported in the
case study methodology. According to MacNealy (1997), case studies are a
qualitative tool and an asset to use for collecting information from a small sample
and to increase understanding of a particular research issue. There are also some
disadvantages in using this methodology, mainly the time that is needed to process
each one of the case studies.
One of the methods for collecting data based on a case study methodology
is the interview. In this research we will use a semi-structured interview in order
to gather data. According to Pawson (1996), this type of interview allows more
types of qualitative data through open questions. According to Pawson (1996)

315
and Houtkooper-Steenstra (1996), the interviewer with this type of method
provides an “environment” more relaxed and also allows the interviewee to it,
answer the questions in their own words and explain certain ideas and opinions.
With this method we managed to gather facts, opinions, goals, plans and ideas
that would be difÞ cult to investigate and analyze by other methods such as Þ lling
out questionnaires (MacNealy, 1997). According to Voss et al. (2002), there are
some disadvantages related to the interviews mainly in terms of the time that will
be necessary to complete the collection of data.
According to Eisenhardt (1989), the case studies can involve single or
multiple cases, and several levels of analysis. In the present investigation, will
be conducted three case studies in laboratories, respectively with, ISO 9001
certiÞ cation, ISO 17025 accreditation both of them. The selection of the target
population is one of the most important aspects when the case study methodology
is used. The concept of a target population is crucial, because the population
deÞ nes the set of entities in which research and its samples are being delineated
Eisenhardt (1989).
In this research project, the target population will be three metrology
laboratories. Semi-structured interviews will be performed with the person
responsible for the laboratory management system. According to Mintzberg
(1979), cited in Eisenhardt (1989), there is no problem if we have a small sample,
if we have tried to go into organizations with a well-deÞ ned focus to collect
speciÞ c data systematically.
4. RESEARCH QUESTIONS
By the end of this research project, we intend to answer the following
questions:
- Which are the main reasons for a metrology laboratory implement a
quality management system according to the ISO 9001 standard or
the ISO 17025 one or both?
- Which are the most evident organizational changes after the
standard(s) implementation?
- Which are the main difÞ culties encountered in the implementation
phase?
- What is the standard implementation impact on a organizational
level, on a technical and on Þ nancial level?
- Are there substantial differences between an ISO 9001 and an ISO
17025 laboratory?
- Which is the most important standard for a metrology laboratory?
ISO 9001, ISO 17025, both?

316
5. CONCLUSIONS AND FUTURE WORK
Based on the literature review carried out we were able to conclude that
there are a considerable number of published papers related to the beneÞ ts of
ISO 9001 and ISO 17025 standards. However, it is very common the paper
analyzed the standards separately and not in an integrated perspective. ISO 9001
and ISO 17025 had been developed in order to be integrated and used together
in a unique management system. Additionally, we also found out that there are
few studies about the importance of metrology for the differentiation and quality
improvement of the organizations.
Sažetak:
ISO 9001 ILI ISO 17025: KOJA JE VAŽNIJA ZA MJERNE LABORATORIJE
Tijekom prošlog desetlje a porastao je broj organizacija u Portugalu, kao i u brojnim
drugim zemljama, koje imaju certiÞ ciran sustav upravljanja kvalitetom. Sukladno
zahtjevima ISO 9001 norme sve certiÞ cirane organizacije trebale bi vršiti umjeravanje
svoje mjerne opreme. Na taj na!in organizacije mogu jam!iti pouzdanost i kvalitetu
mjerenja i koristiti podatke za pra enje kvalitete proizvoda i njezino poboljšanje. Me"utim,
nije nužno da mjerni laboratorij bude certiÞ ciran po ISO 9001 ili ISO 17025. Trenutno
mnoge organizacije imaju mjerne laboratorije u kojima vrše umjeravanje mjerne opreme
za svoje potrebe. Te organizacije imaju certiÞ ciran sustav upravljanja kvalitetom sukladno
sa zahtjevima ISO 9001 norme i sve njihove organizacijske jedinice tako"er ispunjavaju
zahtjeve ove norme. S druge strane, postoje organizacije s akreditiranim laboratorijima
sukladno zahtjevima norme ISO 17025. Obi!no su to samostalne organizacije i
njihovi mjerni laboratoriji u biti pružaju usluge umjeravanja mjerne opreme državnim
kompanijama. Ti laboratoriji mogu biti sastavnice organizacija koje nemaju certiÞ ciran
sustav upravljanja kvalitetom sukladno nacionalnoj ili me"unarodnoj normi. Nadalje,
postoje organizacije koje imaju certiÞ ciran sustav upravljanja sukladno sa zahtjevima
norme ISO 9001, ali i akreditirane mjerne laboratorije sukladno sa zahtjevima norme
ISO 17025. U tom slu!aju mjerni laboratorij treba ispuniti zahtjeve obiju me"unarodnih
normi. Cilj ovo istraživanja i rada je analizirati, u Portugalu, razinu zna!aja ISO 9001
i ISO 17025 normi za postizanje kvalitete mjernih laboratorija.
Klju ne rije i: ISO 9001, ISO 17025, certiÞ kacija, akreditacija, sustav
upravljanja kvalitetom, metrologija.

317
6. REFERENCES
1. BUNDAY, Benjamin D., ALLGAIR, John A., CALDWELL, M., SOLECKY, Eric
P., ARCHIE, Charles N., RICE, Bryan J., SINGH, B., CAIN, Jason P., EMAMI,
I. (2007). “Value-Added Metrology”. IEEE Transactions on Semiconductor
Manufacturing, Volume 20, Nº 3, pp 266-277.
2. DICK, Gavin, GALLIMORE, Kevin, BROWN, Jane C. (2001). “Does ISO 9000 Give
a Quality Emphasis Advantage? A Comparison of Large Service and Manufacturing
Organizations”. Quality Management Journal, Volume 8, Nº 1, pp 52-61.
3. DICK, Gavin, GALLIMORE, Kevin, BROWN, Jane C. (2002). “Does ISO 9000
accreditation make a profound difference to the way service quality is perceived and
measured?”. Managing Service Quality, Volume 12, Nº 1, pp 30-42.
4. EISENHARDT, Kathleen M. (1989). “Building Theories from Case Study Research”.
The Academy of Management Review, Volume 14, Nº 4, pp 532-550.
5. FONSECA, Luís (2002). “Impacto da ISO 9001:2000 na competitividade económica
e social portuguesa”. Opção Q, Nº 23, pp 28-30.
6. GUERREIRO, Rosário (2001). “Chegou a hora da certiÞ cação de serviços”. Opção
Q, Nº 21, pp 62-63.
7. HOUTKOOP-STEENSTRA, Hanneke (1996). “Probing behaviour of interviewers
in the standardised semi-open research interview”. Quaiity & Quantity 30, pp 205-
230.
8. KARNES, Carol L., KANET, John J. (1994). “How the Apparel Industry Measures
Up to Quality Standards”. Quality Progress, Volume 27, Nº 2, pp 25-29.
9. MACNEALY, Mary Sue (1997). “Toward Better Case Study Research”. IEEE
Transactions on Professional Communication Society, Volume 40, Nº 3, pp 182-196.
10. MARTÍNEZ-SÁNCHEZ, Sergio, LAGUNA-AGUILAR, Fabiola M. C. (2009).
“Metrology Impact in Technological Universities, Mexico”. Cal Lab - The
International Journal of Metrology, Volume 16, Nº 1, pp 54-56.
11. NARA, Yoshihiro (2003). “Research Laboratories Conforming to ISO/IEC 17025”.
International Journal of PIXE, World ScientiÞ c, Volume 13, Nº 1 e 2, pp 5-9.
12. NORONHA, José Leonardo, MAGALHÃES, João Gabriel (2006). “Sistema de
gestão da qualidade para laboratório de metrologia de acordo com a NBR ISO/IEC
17025:2005”: XXVI Encontro Nacional de Engenharia de Produção - ENEGEP.
Fortaleza, Brasil.
13. NP EN ISO/IEC 9001:2008 “Sistemas de gestão da qualidade - Requisitos”.
Instituto Português da Qualidade, Lisboa, Portugal.
14. NP EN ISO/IEC 17000:2005 “Avaliação da conformidade. Vocabulário e princípios
gerais”. Instituto Português da Qualidade, Lisboa, Portugal.
15. NP EN ISO/IEC 17025:2005 “Requisitos gerais de competência para laboratórios
de ensaio e calibração”. Instituto Português da Qualidade, Lisboa, Portugal.
16. PAWSON, Ray (1996). “Theorizing the interview”. The British Journal of Sociology,
Volume 47, Nº 2, pp 295-314.
17. PEÑA, Mariano Martín (2002). “Medir para progresar. Importancia de la Metrología
en la sociedade”. Forum Calidad, Nº 128, Año XIII, pp 56-58.
18. PIZZOLATO, Morgana, CATEN, Carla S., JORNADA, João A. H. (2008). “A
inß uência do sistema de gestão de laboratórios nos resultados dos ensaios de

318
proÞ ciência da construcção civil”. Jornal Gestão e Produção, Volume 15, Nº 3, pp
579-589.
19. PRADO FILHO, Hayrton Rodrigues (2010). “A interação entre a ISO 9001 e a ISO
17025”. Obtido em: http://qualidadeonline.wordpress.com.
20. PRIETO, Yeniseis Odelín (2008). “Good Laboratory Practices and the ISO
9001:2000 standards”. Biotecnología Aplicada, Volume 25, Nº 3, pp 258-261.
21. RAMJUN, Bibi Farzeena Shehroze (2009). “Impact of Accreditation to ISO/
IEC 17025 in Accredited Testing Laboratories in Mauritius”. Tese de Mestrado.
University of Mauritius, República da Maurícia.
22. SAMPAIO, P., SARAIVA, P., GUIMARÃES RODRIGUES, A. (2009). “ISO 9001
CertiÞ cation Research: Questions, Answers and Approaches”, International Journal
of Quality and Reliability Management, Vol. 26 Nº 1, pp. 38–58.
23. SANTOS, Cândido (1992). “Aprofundar o carácter voluntário do Sistema”. Opção
Q, Nº 1, pp 6-10.
24. SANTOS, Lucia Lima, MAINIER, Fernando Benedicto (2010). “A Evolução do
Sistema de Gestão da Qualidade em Laboratórios de Ensaio e Calibração e a sua
Importância para as Relações Comerciais”: VI Congresso Nacional de Excelência
em Gestão. Niterói, RJ, Brasil.
25. SOUSA, Carlos (2008). “Metrologia – Notas Históricas”. Cadernos Técnicos,
Centro Apoio Tecnológico à Indústria Metalomecânica: Porto, Portugal.
26. SOUSA, Carlos (2008). “SPQ – Sistema Português da Qualidade”. Cadernos
Técnicos, Centro Apoio Tecnológico à Indústria Metalomecânica: Porto, Portugal.
27. VIM (2008). “Vocabulário Internacional de Metrologia”. Instituto Português da
Qualidade, Lisboa, Portugal.
28. VOSS, Chris, TSIKRIKTSIS, N., FROHLICH, M. (2002). “Case research in
operations management”. International Journal of Operations & Production
Management, Volume 22, Nº 2, pp 195-219.