At Comercializadora Escambray, since 2014, intensive and careful work has been carried out that, with a methodological, systemic and systematic approach, aimed to study and interpret the different criteria and points of view that emerged at each moment related to the possible changes to be made in the version that for September 2015 should be published by ISO. In this sense, and with certain systematicity, various works were prepared and disseminated among all the organization's interested parties to guarantee the assimilation of these changes and the updating of said parts to find the best way to address the transition that was coming; also, that the transition period to the new version of the standard was smoother, more understandable and easier.In the bibliography mention is made of some of the referred works.
With the publication of the new version, as planned in September 2015, the proposed modifications were finally available with clarity and precision.
In October 2015, the organization was immersed as planned in an interesting, highly professional and very helpful Follow-up Audit of our Quality Management System, certified by the National Office of Standardization of the Republic of Cuba based on ISO 9001: 2008, with positive results. An interesting recommendation that emerged from this audit was the development of a work strategy to move from ISO 9001: 2008 to the new version of the 2015 standard.
Consequently, the steps to follow for the transition period and the update of our system to the new ISO 9001: 2015 version are presented in a simplified manner. We think that the directed and self-taught training that has been developed so far will be able to facilitate such an intention, and will contribute positively to its being carried out in a less traumatic way and in a reasonable time.
Proposal of steps to follow.
- Study individually and collectively, to strengthen teamwork, the new requirements of ISO 9001: 2015. To guarantee this step, the new versions of the ISO 9000 and 9001: 2015 standard were published on the Corporate Intranet in the corresponding site, several works have been published, several workshops and meetings have been held, and several conferences have been given on the most significant changes in the new version of the standard, directed with special emphasis to senior management, quality managers and other interested parties with responsibilities in the system. Carry out a diagnosis on the current management system based on the new ISO 9001: 2015 version. Esto, permitiría conocer e identificar los puntos que ya se tienen en el sistema actual, los que aun teniéndose deben ser revisados, mejorados y actualizados a partir de las posibles modificaciones en las exigencias de algunos requisitos de la nueva versión y aquellos que no se tienen en el sistema por lo cual es preciso su diseño, elaboración e implementación. Para dar cumplimiento a este requisito, se diseñó y aplicó una Matriz de Autoevaluación, automatizada y digitalizada, que se encuentra al alcance de todos los trabajadores en la Intranet Corporativa y que fue aplicada en todas las entidades de la organización, incluyendo un documento de carácter metodológico que precisaba en detalles todo lo concerniente a la aplicación, recolección de la información, procesamiento e interpretación de los resultados. Esta propuesta conforma una especie de Lista de Chequeo preliminar, que incorpora los requisitos de la nueva norma, y que en algunos casos, por su afinidad, los agrupaba en puntos comunes.
Broadly speaking, it has been possible to identify that of the total requirements of the new version of the standard, 9 of them must be improved and updated and there are not a total of 8.
- Once everything new has been identified, devise an action plan. This action plan will depend on the results of the diagnosis. In the first instance, the one mentioned below was proposed and we pointed out that it can be modified and adjusted depending on the needs and recommendations that arise from experience during its practical implementation. The steps to follow consist of:
- Form a work team and train them in the new changes to the standard. All directors, managers and heads of processes must be involved in this process, who are responsible for the formation of their respective work teams. Analyze the external and internal context of the organization and how the new situation affects us. In this regard, it is important to internalize that understanding the context of an organization is a process that requires concentration, information and teamwork. This process determines the factors that influence the purpose, objectives and sustainability of the organization, both internal and external, the combination of which can have an effect on the organization's approach to developing and achieving its objectives.Determine the interested parties applicable to the organization's product or service, from suppliers, internal and external clients, externally contracted services, workers, consumers, users and others. At this point, it is important to bear in mind the very definition of the stakeholder rule: "person or organization that can affect, be affected or perceived as affected by a decision or activity." The standard itself mentions as examples: Clients, owners, people of an organization, suppliers, banks, legislators, unions, partners or society in general that may include competitors or pressure groups with opposing interests. Review the scope of the system, so that it is appropriate to the context and stakeholders,without forgetting the services contracted externally. Bear in mind the elements that the standard requires must be taken into consideration when evaluating the context of the organization: “It considers internal factors such as the values, culture, knowledge and performance of the organization. It also considers external factors such as legal, technological, competitive, market, cultural, social and economic environments. The vision, mission, policies and objectives are examples of the ways in which the purposes of the organization can be expressed. " Review the organization's quality policy, mission and vision, guaranteeing the integration between these and that they are as realistic as possible and faithful to the principles of the company and its corporate purpose. At this point we make special emphasis on the fact that it is important to take into account that: “Generally the quality policy is consistent with the overall policy of the organization, can be aligned with the vision and mission of the organization and provides a frame of reference for the establishment of quality objectives ”. Similarly, we emphasize that it is top management who must ensure that the quality policy and quality objectives for the quality management system are established, and that these are compatible with the context and strategic direction of the organization. Among the requirements that the quality policy must meet,They must be expressed very clearly and achieved in practice: a) is appropriate to the purpose and context of the organization and supports its strategic direction; b) provides a frame of reference for the establishment of quality objectives; c) includes a commitment to comply with applicable requirements; d) includes a commitment to continuous improvement of the quality management system.Review the quality objectives,that in the work philosophy of our organization are the objectives defined by processes and that are specified in the Process Sheets. Remember that the organization must establish quality objectives for the relevant functions and levels and the processes necessary for the quality management system and that the proposals for its evaluation and continuous improvement must be substantiated. Other important elements to take into account are specified in the standard itself: a) be consistent with the quality policy; b) be measurable; c) take into account the applicable requirements; d) be relevant for the conformity of products and services and for the increase of customer satisfaction; e) be monitored; f) communicate; g) be updated, as appropriate. As an item is of utmost importance,the organization shall maintain documented information on the quality objectives.Review and update, if necessary, the approaches applied to:recognize direct and indirect customers as those who receive value from the organization; understand current and future needs and expectations of customers; relate the objectives of the organization with the needs and expectations of the client; communicate customer needs and expectations throughout the organization; plan, design, develop, produce, deliver and support products and services to meet customer needs and expectations; measure and track customer satisfaction and take appropriate actions; determine and take action on the appropriate needs and expectations of relevant stakeholders that may affect customer satisfaction; actively manage customer relationships for sustained success.Review the process map, ensure that it is simple, brief, but well understood and interpreted by all stakeholders, and at the same time operational and easy to apply. Complex process maps made up of many activities should be avoided. It is important in its conception to group activities related to a process and in the precision of the objectives, to make a disaggregation of the Key Results Areas associated with each of these processes. This facilitates the evaluation of the objectives and the precision and better identification within each process of any problem or non-conformity that may affect its effectiveness. Review and analyze the processes, their interactionand if considered appropriate to take advantage of to simplify them. This is a key element for its operation. The ideas expressed in the previous point are valid in this one. Review how risks are managed in the organizationWhat methods and approaches will be used and, if necessary, develop a methodology for their management. It is specified that this will always be carried out, as it has been until today, by processes and Key Results Areas. It is important to be clear that in order to comply with the requirements of this version of the standard, an organization needs to plan and implement actions to address risks and opportunities. Options for addressing risks may include: avoiding risks, taking risks to pursue an opportunity, eliminating the source of risk, changing the probability or consequences, sharing the risk, or maintaining risks through informed decisions. The methodology to be used will be selected by the organization itself.
The explicit incorporation of this element in the new version of the standard, through the declaration of the concept of risk-based thinking, has created very interesting expectations in the scholars of the subject, so I consider it prudent at this level of analysis to specify what has been raised in this regard by the standard itself in chapter A.4: “Although section 6.1 specifies that the organization must plan actions to address risks, there is no requirement regarding formal methods for risk management or a documented process of risk management. risk management. Organizations can decide whether or not to develop a risk management methodology broader than that required by this International Standard, for example by applying other guidance or other standards. "
And the standard continues, “Not all processes in a quality management system represent the same level of risk in terms of the organization's ability to meet its objectives, and the effects of uncertainty are not the same for all organizations. Under the requirements of section 6.1, the organization is responsible for applying risk-based thinking and the actions it takes to address risks, including whether or not it retains documented information as evidence of its risk determination. "
At present, risk management in the organization has been carried out for several years by processes, taking as a methodological basis that provided by the "Prevention and Risk Management" component of Resolution 60/11 of the Comptroller General of the Republic of Cuba, updated, improved and expanded in the General Self-Control Guide in its 2015 version, an interesting and useful work tool that has allowed to create and consolidate the importance of the concept of risk-based thinking in Cuban companies.
In this sense, it is my opinion, it may be useful to continue the application of this approach, incorporating some new elements that contribute to improving risk management, such as those set out in ISO 31000, or any other methodology that is considered appropriate such As I have previously stated, based on scientific and technical arguments and that are adjusted to the specific activity of the organization, its objectives, serve as a preventive tool, contribute to the improvement of the system and increase the effectiveness of the processes and their interaction. In no case should it be an emotional or imposed decision.
- Update the system documents, identify those that need to be updated and the new ones to be prepared (documented information). Make the decision regarding its new name and identification, in the cases that it is necessary taking into account the new requirements of the standard and those required by the organization. The ISO 9000: 2015 standard when defining precise documented information: “information that an organization has to control and maintain, and the medium that contains it ”, and suggests that“ it can be in any format and medium, and it can come from any source, expanding the suggestion that “it can refer to: the system management, including related processes; the information generated for the organization to operate (documentation); the evidence of the results achieved (records). " It is important to grasp the difference with ISO 9001: 2008, which spoke of "procedures", which in this version is associated with "maintaining documented information"; and "records", associated with "keeping documented information",Although it does not deny that the organization can continue to use such classifications if it has already become common and has become part of its management culture with positive results. In short, if it has added value to document management, its analysis and interpretation, and has contributed to the continuous improvement of the system.
Reiteramos, la nueva versión de la norma no establece requisitos en su estructura y terminología para aplicarse en la información documentada. La estructura y contenido de esta información documentada será la que la organización considere como más pertinente, si relaciona tanto los procesos operados por la organización como la información mantenida para estos propósitos. No hay ningún requisito para que los términos que utilizados se reemplacen por los de la norma. La empresa puede elegir términos que se adecuen a sus propias actividades y operaciones, como puede ser “procedimientos”, “registros”, “protocolos”, “documentación”, en lugar de “información documentada”; o “proveedor”, “socio” o vendedor en lugar de proveedor externo
- Train relevant and involved personnel in new system changes. This training will be methodologically designed with a differentiated character for senior management, quality managers, process managers and workers of the organization. Update internal auditors, who must know in detail the new version of ISO 9001: 2015. This point will be carried out through training courses for internal auditors contracted to recognized, authorized and accredited entities for this purpose. Conduct an internal auditcomplete taking as reference standard ISO 9001: 2015. In this sense, the application of the Checklist is recommended, which will have the new version of the standard as methodological support. At this point, the participation of external auditors from authorized and accredited entities will be requested, in which the internal auditors trained in the previous step will participate, as an important element in the development of skills and habits in conducting audits and to improve their competence. professional in these matters. Establish the necessary corrective actions to close the findings found in the internal audit and present the associated action plan. Conduct management review of the system and implement new objectives, as part of continuous improvement.
Following these steps we would already be prepared to receive the certification audit in 2017, from the perspective and reference of the new version of the ISO 9001: 2015 standard, which must be specified and collegiate with the ONN.
The internal audits that will be carried out on the Quality Management System in 2016 will have ISO 9001: 2008 as a reference standard; However, as part of the transition and improvement of the system, possible changes will be reviewed and proposed for updating and correct adaptation of the system. The loss of certification is clarified, without becoming binding.
BIBLIOGRAPHY.
- Irulegui, Rodríguez A. "THE NEW ISO 9001: 2015 STANDARD An outline based on ISO / DIS 9001: 2014". Professional Development Conference for Auditors of the Certification Body of the National Standardization Office. Havana. Cuba. July 2014 ISO 9000: 2015, Quality management systems - Fundamentals and vocabulary. Fourth edition. 2015-09-15ISO 9001: 2008, Quality management systems - ISO 9001: 2015 requirements, Quality management systems - Requirements. Fifth edition. 2015-09-15ISO / TC 176 / SC 2 / N 1147. Secretariat of ISO / TC 176 / SC 2. June 2013 Luis, A. “The future of ISO 9001: 2015. Preparing for change. ” Master Conference given at the National Workshop on Quality Management. Escambray Marketing Company. Havana. Cuba. May 2014. Luis, A."ISO 9001: 2015. "Projection, changes and perspectives until 2025". Master Conference given at the National Business Management Workshop. Agrarian University of Havana. Cuba. April 2014. Luis, A. "Non-conformities and their proper management." Master Conference given at the National Workshop on Quality Management. Escambray Marketing Company. Havana. Cuba. May 2014. Luis, A. “ Preparing for change. Comments on planned changes in ISO 9001: 2008. " Training course. Quality Management Workshop. Escambray Marketing Company. Havana. October 2013 Luis, A.Comments and reflections on planned changes in ISO 9001: 2008. Training course. Quality Management Workshop. Escambray Marketing Company. Ciego de Avila. October 2014. Luis, A.; Gretel, Dopico Leyva; Miriam Celeste, Benítez Rivera; Camilo, Company Azcuy: “A perspective view of the new version of ISO 9001: 2015. Preparing for change. ” Escambray Marketing Company. Havana. January 2015. Oriol, Martín Martín, A. “Detailed structure of the new ISO 9001: 2015 standard”.TOP Quality Consulting. "ISO 9001: 2015 and beyond - Preparing for the next 25 years of standards for quality management." Free translation of an article by Nigel H. Croft, President ISO / TC 176 / SC 2, QUALITY SYSTEMS - August 28, 2012. Viegas, M."ISO 9001, the world's most popular standard is changing." Draft of the new ISO 9001: 2015. [email protected]. www.bsigroup.es
