Risk-based thinking of ISO 9001:2015 — The new methods, approaches and tools of risk management

Ezrahovich, Alex Ya.; Vladimirtsev, Arcadi V.; Livshitz, Ilya I.; Lontsikh, Pawel A.; Karaseva, Victoriya A.

doi:10.1109/itmqis.2017.8085872

Cited by 16 publications

(11 citation statements)

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“…The adoption of practices for risk management does not imply the establishment of specific methods, neither the adoption of ISO 31000 (Fonseca, 2015;International Organization for Standardization, 2015); although several authors, such as Sitnikov & Bocean (2015), Atan et al (2017), Chiarini (2017) and Ezrahovich et al (2017), present in their studies, proposals for the incorporation of risk management prescribed in the referred standard, into the context of NBR ISO 9001:2015. According to Samani et al (2017), a reason for risk management to be integrated in other organizational process is the explicit recommendation of ISO 31000.…”

Section: Risk Management and Iso 9001:2015mentioning

confidence: 99%

“…ISO 9001:2015 has incorporated significant and challenging changes in its latest update, such as the concept of risk-based thinking (International Organization for Standardization, 2015; Rampini et al, 2019). However, the standard does not indicate how the new requirements should be addressed by each organization, leaving them the decision of what is more appropriate to their context (International Organization for Standardization, 2015;Fraser & Simkins, 2016;Ezrahovich et al, 2017;Vasile, 2017;Anttila & Jussila, 2017;Perdigão et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

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From theory to practice: a risk management model for SMEs in the context of ISO 9001

Martins

Silva

Gaudêncio

2021

Prod.

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Paper aims: To fulfill risk-based thinking (RBT), most companies opt for widespread methods as FMEA, even with their limitations. This research aims to develop a model for small and medium-sized enterprises (SMEs) relying on literature, practical and normative aspects, to accomplish RBT required by ISO 9001:2015.Originality: This study represents an original contribution once its analysis and results guide a highlighted need in the literature. By discussing RBT from three different perspectives, this paper provides relevant insights for researchers and practitioners in quality and risk management. Research method:The action research was conducted within a Brazilian SME, where the risk management model was implemented and analyzed through five cycles. The techniques to collect data were participant observation, documentary analysis, and semi-structured interviews, analyzed through attribute agreement analysis. Main findings:Unlike the isolated use of widespread methods, this model contains all the aspects needed for RBT. Its applicability is directly related to the level of experience on risks and ISO 9001, emphasizing the organizational aspects needed. Implications for theory and practice:A comprehensive model allows SMEs to understand better the concepts associated with RBT while incorporating an adapted approach to their contexts. Researchers can use the model to analyze its applicability for SMEs from different contexts.

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Section: Risk Management and Iso 9001:2015mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

From theory to practice: a risk management model for SMEs in the context of ISO 9001

Martins

Silva

Gaudêncio

2021

Prod.

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“…There are no special requirements for the organization to maintain or retain documented information related to actions to address risks and opportunities. Organizations can choose to do so and this will be in�luenced by the size and nature of the organization (Ezrahovich et al, 2017). In addition to process risks, it is also shown how to identify safety and environmental risks and evaluate risks using a risk matrix and reduce risks using a risk reduction hierarchy (Asbury, 2013).…”

Section: Key Word: Risk Basedmentioning

confidence: 99%

“…Operational risks and opportunities can be addressed through process management, for example, delivery performance. Therefore, to introduce the concept of Risk-Based Thinking (RBT) and explain how the risk management implied in any company can help reduce risks and increase opportunities (Ezrahovich, Vladimirtsev, Livshitz, Lontsikh, & Karaseva, 2017). The RBT can be implemented in any area in the organization for example in the organization structure, in strategy and the system, or 3S ( Figure.1) As can be seen in Fig 1, an organization can use risk-based thinking through the formulation of an organizational context and determines the problems and requirements that can affect it, then identi�ies risks and opportunities, implements actions to address risks and opportunities, and integrates actions into the QMS process, and evaluates the effectiveness of actions taken to address risks and opportunities.…”

Section: Introductionmentioning

confidence: 99%

Does Risk Based Thinking Matters to Support Business Sustainability A Workshop Provided for Community of Forum Standardisasi Indonesia

Basbeth

2020

JSCD

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Risk can appear in any form such as environmental risk, business risk, and health and safety risk. Many companies especially in manufacturing sectors, they are generally familiar with the process of identification, evaluate and control the environmental, health and safety risk predominantly in operational level to keep their process safe for the people and environment. However, when it comes to business risk, the company's understanding, method, and level of implementation should be adjusted to achieve business objectives and fulfill requirements which implied in the new IS 9001:2018 quality standards. Although there are no special requirements for the organization to maintain or retain documented information related to addressing risks and opportunities, organizations can choose to do so and this will be influenced by the size and nature of the organization. Many organizations don’t have a clear understanding of maintaining and managing lists of business risks and opportunities properly. For this reason, equipping oneself with knowledge related to risk-based thinking and risk management is very important. The aim of the workshop is to improve understanding of Risk-Based Thinking in business processes related to their internal and external business context, specifically in risk identification, evaluating the risks that have been identified, managing the risks at every level effectively. The workshop is carried out in third stages: firstly facilitator explains the workshop material, followed by questions and answers, and finally, the workshop participants were involved in a risk identification and risk assessment simulation. The cognitive aspect of the participants was obtained through a pre-test and post-test, showed that understanding of risk-based thinking is increased, as well as the skill to use tools to be used to manage risk.

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“…Ahora, la norma ISO 9001:2015 aplica la misma estructura general que utilizan otras normas ISO (Estructura de Alto Nivel, de sus siglas en inglés High-Level Structure (HLS)), facilitando así su uso para aquellas empresas que tengan que utilizar diferentes SGs. Además, se enfoca en el razonamiento asentado en el riesgo (ISO, 2018a), por lo que la nueva norma ISO 9001:2015 también contiene un enlace con la norma ISO 31000 (Ezrahovich, Vladimirtsev, Livshitz, Lontsikh, & Karaseva, 2017).…”

Section: Proceso De Revisiónunclassified

Nueva metodología de integración: Six Sigma + Gestión de riesgos + Gestión de la calidad. Aplicabilidad en pymes industriales de la Comunidad Valenciana

Torregrosa¹

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Aconseguir l'eficiència i l'efectivitat empresarial és un aspecte vital per a les organitzacions i, com és tendència des de fa molts anys, es pot aconseguir mitjançant la implantació de sistemes de gestió i metodologies de millora contínua.Els sistemes de gestió més coneguts són aquells desenvolupats per l'Organització Internacional de Estandardització (ISO), sent els més implantats el sistema de gestió de la qualitat en base ala norma ISO 9001 i el sistema de gestió mediambiental en base a la normal ISO 14001. Aquestes normes han suposat un canvi en la forma de gestionar les organitzacions aconseguint un èxit sense precedents.No obstant això, la proliferació d'aquests sistemes de gestió ha donat lloc al fet que les organitzacions implanten diversos sistemes de gestió simultàniament. Per aprofitar les sinèrgies de cada sistema de gestió implantat individualment sorgeix la necessitat de la integració, és a dir, unir els diversos sistemes de gestió presents en un sol sistema integrat. En aquest context, ja que no existeix una metodologia d'integració universal, a la literatura existeixen nombroses metodologies d'integració, ja que tant els acadèmics com les institucions han elaborat diverses metodologies d'integració, que abasten principalment els sistemes de qualitat i medi ambient.Per això, un nou plantejament de recerca podria incloure la integració d'altres sistemes de gestió diferents als esmentats anteriorment, amb la finalitat de diferenciar-se i així crear noves línies de recerca. Per tant, una bona opció seria la integració de la gestió del risc que, encara que no és un dels sistemes de gestió més estesos, comportaria quantiosos beneficis per a les organitzacions, podent així controlar de la forma més adequada els problemes referents als riscos.D'altra banda, quan a la literatura s'analitzen les metodologies d'integració, totes elles engloben únicament sistemes de gestió. No cal obviar, que a més d'aquestes normes, existeixen altres metodologies de millora contínua i de millora de la qualitat, com és el cas de Six Sigma. En referència a aquesta metodologia, es troben estudis on es reflecteixen els beneficis que comporta la implantació de la metodologia Six Sigma en les organitzacions.Arribats a aquest punt, en la present tesi es pretén desenvolupar una nova metodologia d'integració que ajude a les organitzacions a millorar la competitivitat, productivitat i qualitat mitjançant la integració de

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Risk-based thinking of ISO 9001:2015 — The new methods, approaches and tools of risk management

Cited by 16 publications

References 1 publication

From theory to practice: a risk management model for SMEs in the context of ISO 9001

From theory to practice: a risk management model for SMEs in the context of ISO 9001

Does Risk Based Thinking Matters to Support Business Sustainability A Workshop Provided for Community of Forum Standardisasi Indonesia

Nueva metodología de integración: Six Sigma + Gestión de riesgos + Gestión de la calidad. Aplicabilidad en pymes industriales de la Comunidad Valenciana

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