Art Cidem LMF 2018
Art Cidem LMF 2018
ABSTRACT
Purpose: With the transition period for ISO 9001 certified organisations to
migrate to the 2015 edition ending 15th September 2018, this investigation aims
to evaluate the status of ISO 9001:2015 transition process and provide useful
knowledge on the corresponding motivations, benefits, and success factors.
Methodology/Approach: An empirical study of more than 300 Portuguese
organisations ISO 9001 certified, or in certification process, encompassing a
wide range of activities sectors, was carried out.
Findings: As of May 2017, 19% of the respondents already have ISO 9001:2015
certification and all the remaining one’s plan to complete the process in time. The
principal reported benefits are risk-based thinking, mapping of the organisational
context, and stakeholder identification. Simultaneously those were the issues that
required more attention and effort to be mastered and implemented. Additionally,
there is evidence that ISO 9001:2015 enhances both internal and external
organisational issues and generates benefits for all the researched dimensions.
Based on the respondents’ responses, organisations who claimed that external
motivations were the primary drivers to ISO 9001:2015 implementation
systematically rate higher all the benefits when compared with the rating ascribed
by those organisations who claimed internal motivations. Moreover, it is possible
to conclude that the perceived benefits from ISO 9001:2015 implementation and
certification seem to be strongly influenced by two primary dimensions: the
(smaller) organisation size and the (lesser) international presence.
Research Limitation/implication: Due to ISO 9001:2015 novelty, the results of
this investigation should be subject to future confirmation and replicated in other
countries to allow a generalisation of the conclusions. Since the survey is based
on the perceptions of the organisation’s Managers, there is a potential response
bias risk that should be acknowledged.
Originality/Value of paper: With more than 1.2 million ISO 9001 certified
organisation worldwide, this a highly relevant issue both for organisations,
practitioners and academics. Due to ISO 9001:2015 novelty, this investigation
aims to fill this research gap.
Category: Research paper
Keywords: ISO 9001:2015; quality management systems; certification; benefits
1 INTRODUCTION
To sum up, on the one hand, there is a stream of authors that regard the ISO
9001:2015 standard a valuable step towards TQM. Concurrently, these authors
consider that the last revision of the ISO 9001 standard favours the integration
with other management disciplines. Conversely and on the other hand, there is a
stream of authors that acknowledge the ISO 9001:2015 benefits but also some
shortcomings. Furthermore, some authors point out that there is a lack of
awareness and training on ISO 9001:2015. This research study aims to tighten
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QUALITY INNOVATION PROSPERITY / KVALITA INOVÁCIA PROSPERITA 22/2 – 2018 19
Dimension Conclusions/Authors
(2005); Fotopoulos and Psomas (2010); Llopis and Tari
(2003); Willar, Coffey and Trigunarsyah (2015), Castillo-
Peces, et al. (2017).
Influence of the internal/external Internal motivations to implement ISO 9001 can foster
type of motivation for the organisational and process improvements which may
implementation of the ISO 9001 contribute to better quality and customer satisfaction,
on achieving positive results leading to improved financial performance, and
competitive position. External motivation contributes to
better access to markets and image enhancement, but if no
internal improvements are implemented, the external
benefits might not endure: Boiral and Roy (2007); Llopis
and Tari (2003); Martínez-Costa, Martínez-Lorente and
Choi (2008); Prajogo (2011); Sampaio, Saraiva and
Rodrigues (2009).
The impact of the organization There are observed differences in the driving forces for ISO
sector of activity on the positive 9001 certification between manufacturing and services:
benefits of ISO 9001 certification Pekovic (2010).
Influence of the organization size It is more difficult to SME´s because those organizations
on the positive benefits of ISO have fewer relevant resources than larger ones: Gustafsson,
9001 certification et al. (2001); Ismyrlis and Moschidis (2015).
Size is not relevant, since SME´s are more flexible and
open to change than larger ones, and the start point might
be lower: Briscoe, Fawcett and Todd (2005); Lee, To and
Yu (2009); Prado, et al. (2013); Fotopoulos and Psomas,
(2010); Terziovski, Power and Sohal (2003).
The impact of the organization Some research shows a positive relationship between
international presence intensity export intensity (the ratio of export sales to total sales) and
on the positive benefits of ISO firm performance, since firms with a higher rate of export
9001 certification must be more effective and efficient (Bernard and Jensen,
1999; Ling-Yee, 2004), and have access to more
knowledge, therefore becoming more competitive (Ellis,
Davies and Wong, 2011).
Influence of number of years of The benefits of the implementation and certification of an
the certification on the positive ISO 9001 QMS need time to be achieved and growth with
effects of ISO 9001 certification the number of years since certification: Corbett, Montes
and Kirsch (2005); Fonseca (2015b); Martínez-Costa,
Martínez-Lorente and Choi (2008); Terziovski and Power
(2007); Wilson, Walsh and Needy (2003), Castillo-Peces,
et al. (2017)
Time is not significant, and the benefits of certification may
even decrease with time: Casadesus and Karapetrovic
(2005); Casadesus, Karapetrovic and Heras (2004);
Karapetrovic, Fa and Heras (2010); Sampaio, Saraiva and
Rodrigues (2009).
Influence on the intensity of There are synergies between Six Sigma and ISO 9001:
Quality improvement Pfeifer, Reissiger and Canales (2004); Lupan, et al. (2005);
methodologies application (such Dey (2010).
Dimension Conclusions/Authors
as Lean, Kaizen, 6 Sigma) to There is a potential role of the Lean principles and tools
maximize ISO 9001 certification and principles under the requirements of ISO 9001:2008
benefits clauses. There are synergies between the ISO 9001
requirements and improvement Kaizen events and the
application of structured Lean tools: Chiarini (2011);
Micklewright (2010).
With the introduction of the ISO 9001:2015 new approaches, when compared to
the ISO 9001:2008 version, it is advisable to investigate where we stand
concerning the motivations, benefits, and success factors for ISO 9001:2015
certification. Moreover, as the three-year transition for ISO 9001 will end 15th
September 2018, the Accreditation Forum (IAF) that supersedes the developing
of principles and practices for the conduct of conformity assessment, passed a
resolution that as of 15th March 2018, conformity assessment bodies must
conduct all ISO 9001 audits to the new version ISO 9001:2015 (IAF, 2017). With
estimates that more than 50% of ISO 9001 certified organisations still didn´t
complete the transition at the end of 2017 (informal survey carried by the authors
within ISO 9001 certification bodies), the results of this investigation can be of
value to understand and support the ISO 9001:2015 transition process.
2 METHODOLOGY
The research started with the review of the published studies addressing ISO
9001:2015, its benefits and shortcomings and previous studies concerning ISO
9001 certification (motivations, benefits and organisational dimensions that
influence its outcomes). Due to ISO 9001:2015 novelty, there are limited
empirical studies on its implementation and certification, which lead to the
proposal of the following research questions (RQ):
RQ 1: Halfway through the transition period, what is the status concerning ISO
9001:2015 transition and certification?
RQ 2: What are the main benefits achieved with ISO 9001:2015 implementation
and certification?
RQ 2.1: Are there significant differences between Quality Managers and CEOs?
RQ 3: What are the new ISO 9001:2015 themes that your organisation considers
most difficult to implement successfully?
RQ 3.1: Are there significant differences between organisations that have
already been certified and those have not yet done it?
RQ 4: What are the main dimensions that influence the successful ISO
9001:2015 implementation and certification?
Respondents were mainly quality managers (80%), followed by CEOs (11%) and
other quality management collaborators (8%), as one may observe in Fig. 2.
These results suggest that the transition rate is growing and (by May 2017)
almost all organisations plan to proceed with it till 15 September 2018. The
organizations which proceed with the transition to the novel ISO 9001:2015
relied mainly on external consultants (57%) and training (47%); however, among
those organizations that have not yet completed the ISO 9001:2015
transition/certification some are still trying to master the international standard
(40%) and others reported lack of time to do it successfully (37%). From the 72
organisations that proceeded with the transition, 58% made only minor
adjustments to their QMS, while 37% made a full a substantial reformulation.
Based on the results collected, five new ISO 9001:2015 themes were identified as
the most beneficial ones:
• Risk and opportunities determination and adoption of risk-based thinking;
• Organizational context determination - internal and external relevant
issues;
• Determination of the relevant stakeholders and their relevant
requirements;
• Organisational knowledge;
• Change control.
Research question 2.1 aims to evaluate if there are there significant differences
concerning ISO 9001:2015 main benefits, between the Quality Managers and the
CEOs. The graphical depiction of the summarized results (Fig. 9) suggests three
main themes as those that experienced the most beneficial evolution upon the
ISO 9001:2015 implementation: Risk and opportunities determination and
adoption of risk-based thinking, determination of the relevant stakeholders and
their relevant requirements and the organizational context determination- internal
and external relevant issues. One should stress that both CEOs and Quality
Managers pointed out these same three beneficial themes over the others.
Concerning the research question 3 “What are the new ISO 9001:2015 themes
that your organisations consider most difficult to successfully implement?” the
summarized results are depicted in Fig. 10. These results (breakdown by
companies already certified and not yet certified) concerning the most difficult
themes to be implemented (or the themes expected to be most difficult to
implement) suggest that both the organizations that proceeded with the transition
to the ISO 9001:2015 and those that did not point out the “Risk and opportunities
determination and adoption of risk-based thinking” as the theme presenting more
challenges to implement. Additionally, the “Determination of the relevant
stakeholders and their relevant requirements” and “Organizational context
determination- internal and external relevant issues” are mentioned by both
groups as other themes indeed difficult to implement (companies that proceeded
with the transition) or expected to be difficult to implement (companies that not
yet proceeded with the transition).
To answer research question 3.1 “Are there significant differences concerning the
ISO 9001:2015 most difficult themes, between organisations already certified
with ISO 9001:2015 and those that have not yet done it?”, the Chi-Square
statistical test was adopted to ascertain statistical differences between the
distributions of the two groups. The p-value suggests that based upon the
collected results there is no evidence of statistical differences between the two
groups, i.e., the expected difficulties to be faced during the implementation
process are in fact those that are experienced by the companies that proceeded
with the transition.
∑ ∑ + ∑
= 0∗ + 0,5 ∗ +1∗ (2)
8 4 2
To answer research questions 4.1 to 4.5 the statistical Wilcoxon signed rank test
was adopted to assess the statistical relevance of the differences among each one
of the benefits for the two groups. Concerning the Wilcoxon signed rank test, the
solely statistical difference ascertained relates with the benefit- Access to
relevant knowledge that was statistically perceived different concerning the type
of motivation leading to the implementation of the ISO 9001:2015 (Z = -2.292;
p-value < 0.05 (0.022)).
Supported on the summarised results listed in Tab. 4 it is possible to conclude
that the perceived benefits seem to be strongly influenced by two primary
dimensions: the organisation size and the international presence (highest
differences). Both the activity sector where the organisation operates and the
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34 QUALITY INNOVATION PROSPERITY / KVALITA INOVÁCIA PROSPERITA 22/2 – 2018
4 CONCLUSION
Halfway through the transition period, concerning ISO 9001:2015 transition and
certification 19% of the respondents are already certified to ISO 9001:2015 and,
from this group, 58% made only minor adjustments to their QMS, while 37%
made a substantial reformulation. From the remaining 81%, 46% plan to
complete the process in 2017 and 52% in 2018; 39% are still studying the ISO
9001:2015 International Standard or lacked time to do it (36%). The rate of
transition to ISO 9001:2015 increased 64% in the first four months of 2017 when
compared to 2016b (Conclusions concerning RQ1).
Relating to RQ2, “what are the main benefits achieved with ISO 9001:2015
implementation and certification” (respondents: ISO 9001:2015 certified
organisations) the results are Risk and opportunities determination and adoption
of risk-based thinking” (67%), followed by “Organizational context
determination – internal and external relevant issues” (36%) and the
“Determination of the relevant interested parties and the relevant requirements”
(29%).
To statistically assess if a significant difference does exist among the perceptions
expressed by the CEOs and those expressed by Quality Managers (RQ 2.1) the
Chi-Square statistical test was applied. The p-value (0.619) suggests that based
on the collected results there is no evidence of statistical differences between the
two groups, however, due to the CEO’s small sample size, this should be further
investigated.
Following with RQ3, “the new ISO 9001:2015 themes that the organisation
considers most difficult to successfully implement (respondents: ISO 9001:2015
certified organisations) are also “Risk and opportunities determination and
adoption of risk-based thinking” (57%), “Organizational context determination –
internal and external relevant issues” (31%) and the “Determination of the
relevant interested parties and the relevant requirements” (24%). The Chi-Square
statistical test was adopted to ascertain if there are statistical differences between
the distributions of the two groups (RQ 3.1). The p-value suggests that based
upon the collected results there is no evidence of statistical differences between
the two groups, i.e., the expected difficulties to be faced during the
implementation process are in fact those that are experienced by the companies
that proceeded with the transition.
ACKNOWLEDGEMENTS
The authors would like to acknowledge the contribution of the respondents.
CIDEM Centro de Investigação e Desenvolvimento em Engenharia Mecânica
R&D unit is funded by the FCT – Portuguese Foundation for the Development of
Science and Technology, Ministry of Science, Technology, and Higher
Education, under the Project UID/EMS/0615/2016. This study had the financial
support of FCT Fundação para a Ciência e Tecnologia of Portugal under the
project UID/CEC/00319/2013. Pedro Domingues is supported by FCT Post-Doc
Grant Reference SFRH/BPD/103322/2014.
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40 QUALITY INNOVATION PROSPERITY / KVALITA INOVÁCIA PROSPERITA 22/2 – 2018
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ABOUT AUTHORS
Luis Miguel Ciravegna Martins da Fonseca – professor at Instituto Superior de
Engenharia do Porto (ISEP), School of Engineering, Polytechnic Institute of
Porto, Portugal, and a researcher at the Center for Research and Development in
Mechanical Engineering in Porto. An ASQ fellow, he holds a doctorate in
management from Lisbon University Institute in Portugal, and an electrical
engineering degree from Porto University, e-mail: lmf@isep.ipp.pt. Author’s
ORCID: http://orcid.org/0000-0001-5668-0656.
José Pedro Domingues – received the Bachelor degree in Chemistry (1996), the
MSc Degree in Textile Environmental Chemistry (2001) and a PhD Degree in
Industrial Engineering and Systems (2013) all of them from the University of
Minho. He is an invited professor at ISEP – Porto School of Engineering and
researcher at the University of Minho in Braga, Portugal, e-mail:
jpd@isep.ipp.pt. Author’s ORCID: http://orcid.org/0000-0003-1406-4905.
© 2018 by the authors. Submitted for possible open access publication under the
terms and conditions of the Creative Commons Attribution (CC-BY) license
(http://creativecommons.org/licenses/by/4.0/).