This work aims to be a methodological guide for the design of the implementation process of a QMS (Quality Management System) according to the series of standards of the ISO (World Organization for Standardization) 9000: 2005for the products and / or services of any company through the development of action and monitoring plans, it can also provide general knowledge on the subject to the personnel who access it in the companies. The proposed methodology provides entities with tools and techniques and indicates the moment in which they should be applied to make the diagnosis of the current situation of the QMS and compliance with the requirements of ISO 9001: 2008. It also allows establishing the maps of processes and critical variables of these, giving rise to the identification of the actions and the design of the action plans in the short, medium and long term to fulfill the requirements of the standard.
Introduction
From the business point of view, the benefits of quality are high. If we start from the fact that most businesses are very similar to each other, that there is no differentiation between the products that are offered and that the competition is greater every day; then we can see in quality the solution to our problems. We will be able to differentiate ourselves by excellence in our service and create the image of our clients who will never experience such satisfactory experiences anywhere else as in our company.
In the present work, a design is proposed for the implementation of the Quality Management System according to the series of ISO 9000 standards for any company that allows an adequate future implementation of the system through the development of action and monitoring plans.
The essential aspects that contribute to the achievement of the previous goal are the following:
Know the theoretical framework regarding the subject matter covered.
Know the current status of compliance with the requirements of ISO 9001: 2008 in organizations that wish to apply it.
Establish the process map and its interrelationships for the key management processes within the system.
Define the actions that guarantee the effectiveness and efficiency for the future application of the system.
Define the action and monitoring plans for the future application of the system.
As a core structure, the theoretical generalities that cover topics such as the origin and development of the quality term, the Quality Management Systems, their origin, the role they play and importance in the TQM (Movement for Total Quality) philosophy are established., the family of ISO 9000 Standards regarding their origin and development, general methodology according to ISO for the implementation process of a Quality Management System, considerations about the excellence that a Company could achieve when accessing the certification process pos ISO. Questions such as why apply the organizational diagnostic methodology with a focus on quality of the ISO 9000: 2005 series are answered. and no other, the diagnosis is established for the implementation process of a Quality Management System according to the series of ISO 9000: 2005 standards which can be used in any company.
Development
The Quality Management Systems (QMS) are aimed at obtaining consistent results through a coherent execution of the process, they provide the means to sustain the profit obtained in the improvement activities. Doing so in this way constitutes a prerequisite for effective improvement. QMS produce consistent performance whether good or bad. Thus, they provide a solid foundation for managing the process.
Based on these facts, it is necessary to provide companies with a methodology that allows them with their own means, if necessary, to carry out activities related to the diagnosis, design, implementation, analysis and improvement of the QMS according to the series of ISO standards (World Organization Standardization) 9000: 2005.
Already in the diagnostic process itself, it begins by identifying the general objectives that are desired with the implementation of a QMS in the entity, these being in line with the reason for the organization's QMS certification by ISO.
On the other hand, the identification of the expectations of the interested parties must be carried out, since when applying a QMS in the organization it is assumed that they want to satisfy the expectations of various interested parties such as:
Customers and end users
Employees
Society
With this, the company has the possibility of having a service and / or product that meets all the requirements, ensuring that the entity is more efficient and effective, which has a positive impact on the country's economy and society.
It is very important to obtain information on the ISO 9000: 2005 family of standards, for this you must start from studies, consultations and detailed use of the standards themselves, which have been prepared to assist organizations of all types and sizes in the implementation and operation of SGC.
The application of the ISO 9000: 2005 series of standards in a QMS has to be influenced by the particular objectives of the products and / or services, the processes and the specific practices of the organization, therefore it is advisable to carry out a diagnosis of the current status of the entity's QMS based on the requirements that it must meet according to ISO 9001: 2008 for its future certification.
Obtaining help in the implementation of a QMS, the Entity should not only rely on the ISO 9000: 2005 series of standards, but should also seek help on specific issues.
To establish the design process of a QMS, it is necessary, first of all, to know the current situation in which the organization finds itself. This is carried out by two fundamental methods: Self-evaluation and evaluation by an external organization, which can be used separately or simultaneously.
Below are the set of stages into which the diagnosis process in the joint venture is divided with the tools applied and results obtained in a practical way for this step of applying the methodology used.
Stage No.1: Establishment of the premise (s) and objective (s) of the diagnosis.
For the preparation of the diagnosis, the basic premise is that it must cover all the elements and principles of a QMS according to the series of ISO 9000: 2005 standards.
The aforementioned implies that with regard to the objectives, the need to:
Know the relationship between the requirements of the ISO 9001: 2000 Standard and the different areas of the Company.
Know the status of compliance with the requirements of the ISO 9001: 2000 Standard for the SGC in the Company.
Stage No.2: Establishment of the necessary tools to apply in the diagnosis.
In order to theoretically know the fundamentals of the QMS as well as the requirements that must be met by it to access the future certification, and based on the premise set in Stage No.1, the following working tools are taken as the first tools:
NC ISO 9000: 2005: Quality Management Systems. Foundations and Vocabulary ISO 9000: 2005 (Certified Translation)
NC ISO 9001: Quality Management Systems. Requirements ISO 9001: 2008 (Certified Translation)
ISO 9004: 2000: Quality Management Systems. Recommendations for performance improvement.
For their part, as tools to achieve the objectives outlined in Stage No.1, the following are established:
Diagnostic Matrix, with the aim of establishing the degree of relationship that exists between the requirements of ISO 9001: 2005 and the different areas of the Company.
Check List according to ISO 9001: 2008, in order to know the status of compliance with the requirements of the ISO 9001: 2005 Standard for the SGC in the Company.
Stage No.3: Establishment of working methods.
Starting from the premise drawn in Stage No.1 for this phase of the diagnosis, as well as the objectives defined in it, the need to link the theory and generality contained in the norm itself to a practical point of view within of the organization.
Derived from the above, it is essential to have a vast knowledge of the entire internal process of the entity and the experience of its personnel in the activity, which is why, with this objective, it begins with the conduct of individual interviews and document review in relation to: Director, Assistant Directors, Specialists, Technicians as well as experienced Workers.
In order to achieve reliable opinions, backed by the experience of the staff, a consensus should be established on the criteria issued on the relationship of the requirements of the standard with the areas of the organization, as well as the status of compliance with the requirements of the In the entity, group work sessions are held. The brainstorm is basically used as a working tool.
To determine the number of personnel to be involved in the selected work method, the number of necessary experts is calculated who, taking into account the need for its multidisciplinary nature and other characteristics as well as objectives set in advance, conform to a heterogeneous composition of personal.
Stage No.4: Determination of the relationship between the requirements of the ISO 9001: 2008 Standard and the different areas of the Company.
In order to carry out this stage within the methodology step in which the work is found and in correspondence with the first objective outlined in Stage No.1, the first application tool is used within the diagnosis: the Diagnostic Matrix, defined in Stage No.2 and whose application purpose is in correspondence with the objective of this stage.
The Diagnostic Matrix is formed based on all the requirements set forth in ISO 9001: 2008 and compliance for all QMS against all areas, departments, processes, functions, people of the company, to establish the degree of relationship (strong, medium and weak) presented by these with these requirements.
Here the first group work sessions are carried out, in which the rigorous explanation of the purpose of the study, details and / or clarifications is made to the group of experts previously formed in the previous stage to reach the necessary results.
Stage No.5: Determination of the status of compliance with the requirements of the ISO 9001: 2008 Standard for the QMS.
At this moment, within the methodology step in which the work is found and in correspondence with the second objective outlined in Stage No.2, the second tool, fundamental, of application within the diagnosis is made: the Check List. according to ISO 9001: 2008, defined in Stage No.2 and whose application purpose is in correspondence with the objective of this stage. This constitutes a starting point to start organizing the entire QMS based on the results of this diagnosis according to the standard, hence the importance of applying this tool.
The Check List according to ISO 9001: 2008 is formed based on all the requirements set forth in the aforementioned standard and applies to the entire organization to verify the conformity or non-applicability of a requirement. Here the result obtained with the application of the Diagnostic Matrix is taken into account in relation to the verification of the requirements in all areas of the company that present a strong to moderately strong relationship between them and the former, since weak relationships are equivalent to no interaction between the area and the requirement, therefore its behavior is not significant for the application of the list.
This phase is carried out by applying the Check List according to ISO 9001: 2008 through personal interviews, document review, observations and evidence check, which leads to the results of non-compliance, non-compliance and / or inadmissibility in number of standard requirements in the company.
It is very important to determine the processes necessary to supply the products to the customer, based on the fact that a process is a group or series of logically related activities and tasks that involve people, procedures, equipment and documents needed to exchange materials and / or information. within a specific product, service or output information.
For its part, Clause 0.2 of the ISO 9000: 2005 Standards, in the introduction to the approaches related to the approach of the processes, states that when a process QMS is used, emphasis is placed on the importance of understanding and knowledge of the requirements, the need to consider the processes in terms of added value, obtain results of the execution and effectiveness of the process and the continuous improvement of the processes based on the measured objectives.
A starting point to begin the approach to the process in question is considered the elaboration of the Flow Diagram of the same with the aim of knowing the different activities (processes) that are carried out within it and, implicitly, the different areas involved in the same through a visual representation of the process through symbols and shapes.
The previous tool is used in conjunction with the application of process mapping (SIPOC) for the product and / or service in order to know the suppliers, process input variables, process itself, process output variables, requirements for the output variables as well as the process clients identify the necessary existing processes and that interact with it.
As there are several ISO 9001: 2008 requirements where an organization could add value to its QMS and demonstrate compliance by preparing other documents, although the standard does not specifically require them, the Process Maps (SIPOC) must be used for the achievement of these objectives by including them within the documentation and / or tools used by the QMS.
For the development of the plan to eliminate the existing differences between the current QMS in the entity and the requirements of ISO 9001: 2000, it must be based on the fact that causes have been found that affect compliance with the requirements for the QMS according to ISO 9000: 2008 but the organization is unable to establish a set of specific plans and methods to solve it.
From the above derives the need to use a systematic diagram to develop an approach that identifies the appropriate methods and plans. The systematic diagram method is a technique that helps you think about every aspect of solving a problem or achieving a particular goal (these were originally developed for functional analysis in value engineering).
The process of carrying out systematic diagrams to identify the actions needed to achieve the goal, meeting the requirements according to ISO 9000: 2005, is carried out through an expert method and the results are obtained through a brainstorming.
With the process of identifying plans for compliance with ISO 9000: 2005 requirements, the design phase is reached, starting with the first, of such short, medium and long-term plans using the 5W2H method. Said method provides information on the subject, purpose, location or place of application, time interval for the realization, the people involved, the method and / or tools to be used and the cost of the realization of the same for the organization and they are made according to the assimilation capacity of the latter. They are presented organized in order of time and in turn of requirements.
After the QMS is implemented in the organization, it can carry out periodic internal audits. In this step, ISO 19011 should be used as guidance for auditing, auditor qualification and the management of audit programs.
After the organization's internal review it can carry out audits by an independent certification / registration body. From this derives the need to hire an accredited entity to carry out an audit and certify the conformity of the QMS.
Finally, only the continuous improvement of the organization would remain, reviewing the effectiveness and suitability of the Management System, for which the ISO 9004 Standard provides a methodology for improvement.
A sample of the graph of the exposed methodology and its concatenation by phases with each of the tools used is shown below in Figure No.1.
Fig. 1. Methodology for the implementation of the SGC
Bibliography
Abretch., K. (1992). The services revolution. Havana, BME Training Department MINTUR
Ceja, GG (1995). Planning and organization of companies. Mexico, McGraw-Hill,
Delgado, HC (1997). Development of a culture of quality. Mexico, McGraw-Hill.
Deming, EW (1989). Quality, Productivity and Competitiveness. The exit of the crisis. Spain, Editorial Díaz de Santos SA
Harrington, HJ (1993). Improvement of the company processes. Colombia, McGraw-Hill.
Ishikawa, K. (1988). What is total quality control. The Japanese modality. Havana, Editorial Revolutionary.
ISO (2002). ISO1911 Guidelines for the Audit of Quality and (or) Environmental Management Systems. ISO.
ISO (vig 2008). NC-ISO 9001. Quality Management System. Requirements, NC-ISO: 30.
ISO (vig 2005.). "ISO / TR 10013 Guide to the Documentation of Quality Systems." (ISO): 32.
ISO (vig 2000). ISO 9004 Quality Management System. Recommendations for performance improvement., ISO 71.
ISO (vig 2005). NC-ISO 9000. Quality Management System. Foundations and Vocabulary. N.-. ISO: 75.
Juran, JM (2000). Quality control manual. Mexico, McGraw-Hill.
Murguia, RP and (1998). Management for total quality. Document VI. Managua, National University of Engineering: 22.
