A brief exposition of the positive impact on business management is made from the implementation of the Quality Management Systems taking the ISO 9000 standard as a reference and methodological basis. The changes since their emergence are referred to, and in particular, the associated with the ISO 9001: 2008 standard as part of its continuous improvement in the interest of different audiences, in correspondence with the new scenarios arising from the enormous and rapid changes in the context of this management. Some of these main changes in principles, structure, terms and definitions are shown and commented with a perspective view, and a possible detailed structure of the new version of ISO 9001 for 2015 is provided,This can serve companies as a preliminary preparation to visualize and create the management mechanisms for future changes to their own quality systems.
INTRODUCTION.
Since it was originally published in 1987, ISO 9000 has consistently been the most popular ISO series of standards. Even today, ISO 9001 is still the most successful standard in history, which can be corroborated by the fact that more than 1 million organizations in more than 170 countries have been certified under the famous standard to improve their business. and most can confirm the many benefits of its use.
Now, after 25 years of success, it has made it possible to confirm in practice, according to the authors' judgment, by those companies that have applied it, what Ishikawa has stated and which is synthetically and schematically referred to in figure 1.
In any case, it is worth commenting that there was a slight setback in ISO 9001 certification in recent years worldwide, although this could be considered relatively small if the rigors of the current crisis are taken into account. On the other hand, it is still necessary to achieve a greater penetration of the standard and of the whole issue of Quality Management, in its current broad conception in the business fabric. This means promoting quality in the broadest sense of the word and encouraging organizations to look beyond the fulfillment of a set of requirements, achieving a scenario in which quality management is perceived as much more than an ISO certification. 9001 and really help organizations achieve long-term success.
Quality management
Simplified representation of a company's achievement by applying ISO 9001
Without a doubt, this series of standards has been incredibly successful in promoting quality management around the world, managing to establish a common platform and language for organizations to discuss quality and, on the basis of their own platform and defined requirements, to be able to make comparisons between the management of companies regardless of their specific activities. At the same time, ISO 9001 managed to establish a minimum basis of trust in an organization's ability to supply compliant products, which has facilitated world trade.
Looking at the future, it is possible to express that quality management systems have an interesting influence on the formation of the base of the component related to economic growth and the elevation of the standard of living of the human capital that works in the company, by influencing positively in increasing productivity, reducing costs and thus being able to offer products and services with better prices, which will favorably contribute to making companies more competitive, achieve greater comprehensive development of their human capital and achieve greater market opening; All of this, together with the components of environmental integrity and social equity, are part of the sustainability agenda, as summarized in Figure 2.
Quality as support for economic growth and sustainability.
It should not be forgotten, however, that ISO 9001 is, and probably will continue to be, the entry point for many organizations that want to implement a formal management system. Even though it is not a requirement, ISO 9001 certification by a third-party body will continue to be a key incentive, which will also contribute to the continuous improvement of the system and thus to the management of the company. However, standards, like everything in life, need a periodic review to adapt to new times. Consequently, ISO is now very busy laying the groundwork for the next generation of quality management standards, which should be officially published in September of this year.
THE CHANGES
The first edition of the ISO 9001 standard was published in 1987. Since its first publication, the requirements and characteristics for a quality system that defines this standard have been revised three times:
In 1994, the series standards were revised, keeping the requirements practically unchanged, but some elements were added (to facilitate application) and some paragraphs (to avoid ambiguities).
A summary of how the family of ISO 9000 Standards was formed is shown in Figure 3. Note the existence of three Quality Assurance Models, which constituted the documentary basis or reference standard for the Quality System certification, depending on the specific activity carried out by the organization that sought to achieve such certification.
Subsequently, in the year 2000 the second modification occurs. In this case, it was a profound change in the content and focus of the standards. Since this review, a single standard was consolidated for certification purposes: ISO 9001. Until then, three standards were used for certification, as already mentioned in the previous paragraph, ISO 9001, ISO 9002 or ISO 9003, depending on the characteristics of the quality system to be certified.
In 2008, a new review was carried out mainly focused on clarifying the application of some requirements, facilitating their application, improving their compatibility with other standards such as ISO 14001 on environmental management and increasing their consistency with other standards in the ISO 9000 family, maintaining the initial structure, sections and requirements of the previous version.
A new revision plan for the ISO 9001 standard is currently being developed with a view to a future publication in September 2015, basing the future version on the following general lines:
- Provide a basic set of requirements for the next ten years. Remain a generic standard that can be applied by organizations of any size or sector. Maintain the current approach to process management to obtain the desired results for organizations. take into account the evolution of quality systems and technology related to quality systems since the 2000 revision. Adapt to increasingly complex and dynamic environments in which organizations operate. Apply Annex SL of the ISO Directives to improve Compatibility and alignment with other ISO management system standards. Facilitate effective implementation and conformity assessment by first, second and third parties.Facilitate the interpretation of the requirements by the organizations for their implementation, as well as the performance of audits. Use simple language and writing styles that help the consistent understanding and interpretation of their requirements.
Quality Assurance Model
Synthesis of the documentary and methodological conformation of the ISO Standard: 1994
The 8 principles of quality management are being thoroughly revised despite the fact that they clearly have stood the test of time very well, and only minor adjustments will be necessary to update them for the next generation of quality management standards.
It is foreseeable that regarding the principles, the modification may be as shown in Table 1, which allows us to express that of the 8 principles of the ISO 9001: 2008 version, the new version of the standard would be based on only 7.
The depth and rigor of the current change, like the previous ones, is evident if one takes into account that since October 2010, ISO launched an important study of current and potential users of ISO 9001 and ISO 9004 standards in 122 countries. The objective was to better understand user needs, identify opportunities for improvement, and guide long-term strategic quality management.
The result of the study based on a global survey concludes that of a total of 11,722 respondents, 4,222 cited customer satisfaction as a key factor for implementation and certification, ahead of 3,689 who have indicated "market need". The "best customer satisfaction" has also been cited as the main benefit of the standard by 5,886 respondents, somewhat ahead of "standardized business processes", with 5,821 responses.
It is evident that respondents perceive "improved customer satisfaction" as the main reason for seeking ISO 9001 certification, and the most important benefit of applying the standard.
The authors consider it appropriate to comment that in addition to the fundamental objectives that guide the review, there are proposals for other topics to consider:
Integration of 'risk-based thinking'
- Greater emphasis on the eight principles of quality management (which may even be different from the current ones!) Better alignment with business management processes Knowledge managementLife cycle managementImprovement and innovationTimes / Speed / AgilityTechnology and IT changesIncorporation of "Quality Tools" such as 6 Sigma, QFD, benchmarking and others.
A certain change is the new structure. Since 2012, all Management Systems standards published or revised by ISO must follow an identical structure defined by the ISO Directives, a document that defines how ISO works, in its Annex SL (the old ISO Guide 83). The new standards for Business Continuity Management Systems (ISO 22301: 2012) or Road Safety (ISO 39001: 2013) already follow this structure.
Annex SL defines the common structure and format for all new ISO management system standards and revisions to existing standards. It ensures that there is at least 30% common text between each management system standard and is achieved through promoting it.
The existence of interesting changes that can motivate important changes in the conception of the current quality management system in organizations is appreciable. It is recommended to see table 2.
Table 1. Changes in principles.
| ISO 9000: 2005 and ISO 9004: 2009 | ISO / DIS 9001: 2014 |
| Leadership | Leadership |
| Staff involvement | Staff commitment |
| Process-based approach | Process-based approach |
| System approach to management | - |
| Continuous improvement | Improvement |
| A fact-based approach to decision making | Evidence-based decision making |
| Mutually beneficial supplier relationships | Relationship management |
Table 2. Changes in structure.
| ISO / DIS 9001: 2014 (ISO 9001: 2015) | ISO 9001: 2008 |
| Foreword | Foreword |
| Introduction | Introduction |
| 1 reach | Object and field of application |
| 2. Normative References | Normative references |
| 3. Terms and definitions | Terms and definitions |
| 4. Context of the organization | Quality management system |
| 5. Leadership | Management responsibility |
| 6. Planning | Resource management |
| 7. Support | Product realization |
| 8. Operation | Measurement, analysis and improvement |
| 9. Performance evaluation | (it is in Clause 8) |
| 10. Improvement | (it is in Clause 8) |
| Annex A - Principles of Quality Management | It is not there, you have to go to ISO 9000 or ISO 9004 |
| Bibliography | Bibliography |
Detailed structure of the new ISO 9001: 2015 standard
As it is already known, the future ISO 9001: 2015 standard will respond to the new high-level structure established by ISO in Annex SL.
On May 13, the ISO 9001 DIS (Draft International Standard) was published by ISO / TC 176. The publication constitutes the penultimate stage of the process of developing a standard, so it can be affirmed that it contains a fairly Conformed of what will be the future standard, and that although comments and modifications are still being made, the main lines of the standard have already been drawn.
In this work, an attempt is made to detail the content of each chapter, in order to facilitate familiarization with the complete structure of the ISO 9001: 2015 standard.
- Scope
The main novelty is that the possibility of making exclusions is no longer included here, which happens to be in section 4.3.
- Normative references
For now, the reference to ISO 9000: 2005 is maintained.
- Terms and definitions
New terms and definitions appear to facilitate the understanding of some of the novelties of this edition. Thus, risk or documented information have their definition.
Some of the relevant changes are shown in Table 3.
Table 3. Changes in terms and definitions.
|
ISO 9001: 2008 |
ISO / DIS 9001: 2014 |
| Product | Products and services |
| Exclusions | Not used (see Annex A.5 for clarification of its application) |
| Documentation, records | Documented information |
| Work environment | Environment for the operation of the processes |
| Products purchased | Products and services provided externally |
| Providers | External providers |
- Context of the Organization.
Analysis of the internal and external context (environment), relevant to the purpose of the organization and that could affect its ability to fulfill its mission and achieve desired results. Determine interested parties and their requirements, in order to understand needs or expectations that could affect the satisfaction of the client's requirements and the applicable legal and regulatory requirements.
It is broken down into 4 sections:
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of stakeholders
4.3 Determination of the scope of the quality management system
Determine the limits and their scope of application, considering:
- external and internal contexts 4.1; relevant stakeholder requirements 4.2; the organization's products and services.
4.4 Quality management system
Although it is not essential to have a quality manual, the necessary documents for the QMS (planning, operation and process control) continue to be mandatory.
It is broken down into the following sections:
4.4.1 General
4.4.2 Process approach
- Leadership
Requirements related to the commitment of senior management are reinforced.
- Ensuring the integration of the QMS requirements into the organization's business processes. Ensuring that the QMS achieves the expected results. Promoting awareness of the process approach. Promoting continuous improvement.
No explicit mention is made of the appointment of a management representative for the Quality Management System.
It is broken down into 3 sections:
5.1 Leadership and commitment
5.1.1 Leadership and commitment to the requirements of the quality management system
5.1.2 Leadership and commitment to customer needs and expectations
5.2 Quality policy
5.3 Roles, responsibilities and authorities
This new version specifies “Top management must ensure that the responsibilities and authorities for the relevant functions are assigned and communicated within the organization.” Although there is no explicit mention, as previously mentioned, of the appointment of a management representative for the Quality Management System, it can be interpreted that neither does it deny such possibility, even though this responsibility can be treated in various ways as decided the organization itself. In any case, if you emphasize once again, the responsibility of senior management in relation to the management system.
It is obvious that how "the relevant functions are assigned and communicated within the organization" is a decision of its own depending on its objective and subjective conditions.
Undoubtedly, the elimination of the quality manual and a Management Representative motivate that senior management will now be under the direct scrutiny of the audit teams.
- Planning.
The draft of the new ISO 9001: 2015 specifies that for the determination of risks and opportunities it is necessary for the organization to identify and evaluate its relevant external and internal aspects, based on its vision and mission with the purpose that they cannot affect its capacity. to achieve the expected results.
The risks identified in the phases prior to the implementation of the Management System must be taken into account in this section and, in addition, they must be managed with each change in the Management System.
Proper Risk Management consists of preventing, starting with knowing the risks and identifying them, estimating the possibility that they will occur and what their consequences would be. Then they must be classified in order to develop actions that address them.
The term Preventive Actions is not referred to in this version. If the criterion that the implementation of any management system is a prevention tool in itself is accepted, the preventive sense is further accentuated with the new concept of Risk Management, which will consist of recognizing the risks within an organization and carry out actions to prevent them from occurring. Thus, good production and customer satisfaction can be obtained.
ISO 31000 is referred to as a guide that may be appropriate in certain organizational contexts.
Finally, it is broken down into 3 sections:
6.1 Actions to face risks and opportunities.
The organization must address its risks and also its opportunities in a more detailed and rigorous way. When addressing the analysis and management of your risks, you must take into account: Risk analysis, Risk classification, Risk management, Risk reduction, among other elements of interest.
The emphasis on the terms "risk" (it appears 18 times in the standard) and "efficacy" (it appears 13 times), constitute one more reason for the preventive nature of the standard and the need for systematic and systematic evaluation of the implemented system.
6.2 Quality objectives and planning for their achievement.
With reference to the objectives it is specified:
- Coherent with the policy.MeasurableConsider the applicable requirements.Relevant for the conformity of products and services.MonitoredCommunicatedUpdated
The authors wish to comment on how the new version of the standard maintains the term Measurable when referring to the objectives, as opposed to the quantifiable term as it has become a certain "trend" in certain circles. This, in our opinion, constitutes a respect and recognition that everything measurable does not necessarily have to be quantifiable (intangibles, qualitative), such as tastes, preferences, beliefs, perceptions, tastes and smells perceived, beauty, ugliness, joy, sadness, solidarity, humility, morality (what is moral today may be immoral tomorrow and vice versa), simplicity and modesty (if it is not possible to differentiate the hypocritical from the real, the same action can be interpreted as modesty and simplicity for some and hypocritical for others,it has a high dependence on the receiver and who it interprets). Also, they can be mentioned among others: sadness, joy, anguish, tolerance, understanding, trust, anxiety, hope, faith and love, all very used in social, psychological and other investigations.
More specifically and according to the norm itself, certain intangibles such as: Competences, Organizational Knowledge, Organizational Behavior, Awareness and Communication can be mentioned, among others. Undoubtedly, the measurable can be qualitative or quantitative, a more comprehensive concept than quantifiable.
6.3 Planning of changes.
The planning and control of changes to the QMS must be systematic and planned, and may originate from different factors:
- The external or internal environment Legislation The methods of operations New technologies New expectations of interested parties.
You should consider:
- the purpose of the change and its potential consequences the integrity of the system the availability of resources and the (re) allocation of responsibilities.
- Support
In this clause mention is made to determine the necessary knowledge for the operation of the processes and to achieve the conformity of its products and services. The importance of organizations' knowledge as an intangible asset is highlighted.
Regarding communication, it is necessary to specify what is communicated, when, with whom and how the communication is carried out.
No reference is made to documents and records, instead the term “Documented Information” will be used, which will allow it to be even more flexible. It is specified that the extent of the Documented Information for the QMS may differ between organizations due to:
- The size and type of activities, processes, products and services The complexity of processes and their interactions The competence of people
It is broken down into 5 sections:
7.1 Resources.
7.1.1 General
7.1.2 Infrastructure
7.1.3 Process environment
7.1.4 Monitoring and measurement equipment
7.1.5 Knowledge
7.2 Competition
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creation and update
7.5.3 Control of documented information
- Operation
It addresses all forms of external provision, be it through the purchase of a supplier, through an agreement with an associated company, through the outsourcing of the organization's processes and functions or by any other means. The organization is required to adopt a risk-based approach to determine the type and scope of controls appropriate to each external provider and any external provision of products and services.
It is broken down into 8 sections:
8.1 Operational planning and control
8.2 Determination of market needs and customer interactions
8.2.1 General
8.2.2 Determination of requirements related to goods and services
8.2.3 Review of requirements related to goods and services
8.2.4 Communication with the client
8.3 Operational planning processes
- Design and development planning, inputs, controls, results and changes to design and development
8.4 Control of products and services provided externally.
8.4.1 General
8.4.2 Type and extent of control to external provision
8.4.3 Documented information for external providers
8.5 Production and service provision.
- Operational and change control
8.6 Release of products and services.
8.7 Control of non-conforming results of processes, products and services
- Performance evaluation
It is broken down into 3 sections:
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Data analysis and evaluation
9.2 Internal audit
9.3 Management review
- Improvement
The improvement can be carried out in different ways, among these the following can be specified: reactive (eg corrective action), augmentative (eg continuous improvement), staggered (eg progress), creative (eg innovation) or by reorganization (eg transformation)
It is broken down into 2 sections:
10.1 Nonconformity and corrective action
10.2 Improvement
The new standard will not be limited only to the development of the cycles of non-conformities and corrective actions, Internal and External Audits, and evaluation of customer satisfaction and indicators, but will urge organizations to use more tools to manage opportunities for improvement by organizing the actions to be carried out well.
Possible challenges for the Escambray Marketing Company.
Compliance with international standards and the adoption of quality systems must be considered as an agent of change within the entire organization and an indispensable factor in achieving national and international business.
It is important to continue emphasizing that each worker at Comercializadora Escambray understands and, consequently, acts conscientiously, that a QMS represents an investment to remain in force in the long term and that, by not implementing a system of this nature, the costs of not Quality could represent a considerable proportion of your annual costs. In this sense, the reading of the work “A proposal for the implantation of Quality Costs in the Comercializadora Escambray”, prepared by the authors themselves, can be suggested.
Based on this, Comercializadora Escambray should place special emphasis on risk issues to understand where prevention is, the risks and how they will be managed. However, the sustained work that it has been doing in this regard by having identified the risks by Processes, and carrying out their analysis with the frequency established in its procedures.
On the other hand, in this new edition it is even more essential that the top management of Comercializadora Escambray focus on two areas: risk prevention and visible improvements in the system. Although the specialists of the same have observed that they do comply with the part of visible improvements, the aspects of risk prevention constitute subjects of greater attention and continuous improvement. Even though the difficulties they present in taking preventive measures in an organized manner have been identified, because despite the fact that from the point of view of leadership they are well and know how to manage risk, it has not been possible to integrate it as part of the coherent system quality management.
CONCLUSIONS AND RECOMMENDATIONS
- The year 2015 and beyond will be revolutionary years for companies and organizations in terms of approaches related to Quality Management Systems. These will have to be very well worked and implemented in organizations in accordance with the changes that are coming.The work, although it is not definitive given the stage of the process of developing a standard, in which comments are still issued and made modifications, will allow companies to shape their own vision and business perspective with a preventive nature to better adjust to changes, even when it is perceived that the standard will be more friendly and understandable for certain sectors more focused on services. The language of the entire standard It is more fluid and easy to understand by any reader regardless of their training. Planning,leadership and risk and opportunity management are important axes Greater emphasis is placed on the role of senior management in the design, implementation and effective maintenance of the QMS. The preventive nature aligned to risk management will also be a very positive change and a helpful tool. Increased visibility of the role of the customer and other relevant stakeholders in the design and development of products and services. The process-based approach is reinforced by process performance and performance indicators, the allocation of responsibilities and authority for such processes. The incorporation of specific chapters for Competencies, Organizational Knowledge, Awareness and Communication highlights the role of intangibles within a QMS.The inclusion of the concepts associated with risk and change management provide an interesting and marked approach to prevention, with the aim of responding to the progress that process outsourcing has had in recent times, including Requirements for the goods of external suppliers that are under the control of the organization, not only those of the customer. The emphasis on “interested parties” and the inclusion of change management are aspects closely linked to the Excellence models.The emphasis on “stakeholders” and the inclusion of change management are aspects closely linked to the Excellence models.The emphasis on “stakeholders” and the inclusion of change management are aspects closely linked to the Excellence models.
BIBLIOGRAPHY.
- Irulegui, Rodríguez A. "THE NEW ISO 9001: 2015 STANDARD A sketch from ISO / DIS 9001: 2014". Professional Development Day for Auditors of the Certification body of the National Standardization Office. Havana. Cuba. July 2014.ISO / TC 176 / SC 2 / N 1147. Secretariat of ISO / TC 176 / SC 2. June 2013 Luis, Romero 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, Romero 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.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 quality management standards. ” 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 most popular standard in the world is changing.” Draft of the new ISO 9001: 2015. [email protected]. www.bsigroup.es
