The present work intends to be a methodological guide for the design of the implementation process of a Quality Management System (QMS) according to the series of NC ISO 9000: 2000 standards for the products and / or services of any Company in the country through the development of action and monitoring plans, as well as providing general knowledge on the subject to the personnel who access it in the Companies.
The methodology provides entities with tools and techniques as well as the moment in which to apply them to make a diagnosis of the current situation of the QMS and compliance with the requirements of the NC ISO 9001: 2008 standard, as well as establish process maps 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 for the fulfillment of the requirements present in the Standard.
Introduction
The QMS are directed to obtain 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. Now, how to do it ?, How to achieve it ?, What are the first steps?…
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 NC ISO 9000 standards: 2000.
Development
The diagnostic process itself begins with the identification of the general objectives that are wanted with the implementation of a QMS in the Entity, these being in line with the reason for the organization's QMS certification by the series of standards NC ISO 9000: 2000.
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 wish to satisfy the expectations of various interested parties such as:
Customers and end users: These will be the main beneficiaries and they will be able to feel more directly all the improvements that the implementation of a QMS in the service and / or product entails, thus allowing the possibility of planning and carrying out actions with a high degree of objectivity. that is proposed for the future and avoiding disagreements or rejections with other entities that interact with it.
Employees: Employees, when applying a QMS, will be able to clearly define the general and specific responsibilities of the activity they carry out. From the above, it is derived that greater coordination and a closer link between the areas of the organization can be achieved, hence the actual or potential existing problems that affect the quality of the organization are quickly identified. A closer link will be established with the administration since it has a high responsibility in the implementation of the QMS and the employees are the fundamental cells in this process.
Society: In our days as a result of the increasing increase due to the fact that the majority of companies in the country can implement Business Improvement, the number of Companies that must access the certification process of their products and / or services has risen.
With this, the Company has the possibility of having a service and / or product that meets all the requirements, giving it a certainty in the path of Business Improvement, which would make the Entity more efficient and effective, having a positive impact on the economy of the country and society contributing, once the Business Improvement is implemented, greater competitiveness and higher quality in its production and / or services.
Obtaining information on the family of NC ISO 9000: 2000 standards, to obtain information on the family of NC ISO 9000: 2000 standards, studies, consultations and detailed use of the standards themselves are carried out, which have been prepared to attend the organizations of all types and sizes in the implementation and operation of SGC.
Application of the series of NC ISO 9000: 2000 standards in the QMS, based on the decision that what is sought is the certification of the QMS in accordance with the NC ISO 9001: 2008 standard, the need to use the NC ISO standard is identified 9001: 2008 as the basis for certification.
Starting with the fact that the application of the series of NC ISO 9000: 2000 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, proceed in the particular case. of the organization under study to make a diagnosis of the current situation of the Entity's QMS based on the requirements that it must meet according to NC ISO 9001: 2008 for its future certification.
Obtaining help on specific issues within the QMS, in the implementation of a QMS the Entity should not only rely on the NC ISO 9000: 2000 series of standards, but should also seek help on specific issues.
To carry out this work, data is obtained from various sources, both internal and external, to ensure that the objectives of your QMS are appropriate. This information can also be used later to improve the performance of your processes and is in line with that presented in the Obtaining information on the NC ISO 9000: 2000 family of standards.
All this information is used in a timely manner depending on the phase of work in which it is found, either studying the vocabulary present in the standards, NC ISO 9000: 2005, books or web pages, or in the bibliographic review, using all the standards previously stated and others or during the creation of the Check List, NC ISO 9001: 2008, NC ISO 9004: 2009, NC ISO 10011: 2001 and NC ISO 19011: 2007 adding to this the other existing information supports used and exposed in previous paragraphs.
Establishment of the current situation of the QMS in the organization under study, to establish the design process of any system, you must first of all know the current situation in which the organization finds itself, this is carried out by means of two fundamental methods, which are They can be used separately or both at the same time, one is self-evaluation and the other is evaluation by an external organization.
For this, it begins with the diagnosis according to the approach and the result that you want to obtain in the management of the organization.
Below are the set of stages into which the diagnosis process in the Company is divided, together with the applied tools 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 NC ISO 9000: 2000 standards.
The aforementioned implies that with regard to the objectives, the need to:
- Know the relationship between the requirements of the NC ISO 9001: 2008 standard and the different areas of the Company.
- Know the status of compliance with the requirements of the NC ISO 9001: 2008 standard for the QMS 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), IDT.
- NC ISO 9001: 2008 Quality Management Systems. Requirements ISO 9001: 2008 (Certified Translation) IDT.
- NC ISO 9004: 2009. Management for the sustained success of an organization-Quality Management Approach.
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 the NC ISO 9001: 2008 standard and the different areas of the Company.
- Check List according to NC ISO 9001: 2008, in order to know the status of compliance with the requirements of the NC ISO 9001: 2008 standard for the QMS in the Company.
Stage No.3: Establishment of working methods.
Starting from the premise drawn up in Stage No.1 for this phase of the diagnosis as well as the objectives defined in it, the need is established to link the theory and generality contained in the norm itself to a practical point of view within the organization.
Derived from the foregoing, it is essential to have a vast knowledge of the Entity's entire internal process and the experience of its staff in the activity, which is why, with this objective, we begin with the conduct of individual interviews and document review in relation to: Director, Assistant Directors, Specialists, Technicians as well as experienced Workers.
Knowing the operation of the organization, it is possible to proceed to the conformation of the working methods for the application of the two fundamental tools in this step of the diagnostic methodology.
In order to achieve reliable opinions, backed by the experience of the staff, establish a consensus 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 standard in the Entity Group Work sessions are held where the Brainstorm is basically used as a work tool.
To determine the number of personnel to be involved in the selected work method, the number of necessary experts is calculated, which, taking into account the need for its multidisciplinary nature and other characteristics as well as the objectives set in advance, complies with a heterogeneous composition of personal.
Stage No.4: Determination of the relationship between the requirements of the NC 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 the NC ISO 9001: 2008 standard 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) that these have with these requirements.
Here the first Group Work sessions are held in which, after making the required explanation about the purpose of the study, details and / or clarifications to the group of experts already previously formed in the previous stage, the necessary results are reached.
Stage No.5: Determination of the state of compliance with the requirements of the NC 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 NC 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 NC ISO 9001: 2008 is formed based on all the requirements set forth in NC ISO 9001: 2008 and is applied 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 NC 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 quantity of the requirements of the standard in the Company.
Determination of 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 product., service or specific output information and for its part Clause 0.2 of the NC ISO 9001: 2008 standard in the introduction to the approaches referring to the Process Approach states that when using a QMS with this approach, emphasis is placed on the importance of understanding and knowledge of the requirements, the need to consider the processes in terms of value they provide,obtain results of the execution of the performance and efficiency of the process and the continuous improvement of the processes based on objective measurements.
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, input variables of the process, process itself, output variables of the process, requirements of the output variables as well as the process clients identify the necessary existing processes and that interact with it.
However, the use of the Process Map (SIPOC), as a primary document, provides another tool, the Cause and Effect Matrix, with the input variables and output requirements of each of the processes necessary to fulfill the requirements in the organization in order to determine the critical variables of each of these processes (KPIV's). This Matrix emphasizes the importance of understanding the client's requirements since it takes into account the rating that the output variables of the process have for it.
The process of realizing the Cause and Effect Matrix is carried out through an Expert Method process and the results are obtained through a Brainstorm and the correlation of the output variables against the input variables of the process.
As there are several NC 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, Process Maps (SIPOC) should be used and the Cause and Effect Matrix for achieving these objectives by including them within the documentation and / or tools used by the QMS.
Development of the plan to eliminate the existing differences between the current QMS in the Entity and the requirements of the NC ISO 9001: 2008 standard, for the development of the plan to eliminate the existing differences between the current QMS in the Entity and the requirements of the standard NC ISO 9001: 2001 must be based on the fact that causes have been found that affect compliance with the requirements for the QMS according to NC ISO 9001: 2008, but the organization is unable to establish a set of specific plans and methods to resolve it.
From the above derives the need then 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). Resembling a tree with an increasing number of branches developing root and branch relationships between various parts of a method, this tool helps select the optimal method to achieve a goal and indicates the level of action it is at.
The process of carrying out the Systematic Diagrams to identify the actions needed to achieve the goal, meeting the requirements according to NC ISO 9001: 2008, is carried out through an Expert Method and the results are obtained through a Brainstorm.
With the process of identifying plans for compliance with NC ISO 9001: 2008 requirements, the design phase is reached, starting with the first, of said short, medium and long-term plans using the 5W2H Method. Said method provides information on the matter, 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 perform according to the assimilation capacity of this. They are presented organized in order of time and in turn of requirements.
Through the plans designed, among other results, the need to implement other necessary processes that do not exist in the organization, tributary to the requirements of the NC ISO 9001: 2008 standard and that interact in one way or another with the process of the product and / or service to be certified.
At this point the organization only has to carry out the plans designed implementing the identified actions and monitoring the progress of the program.
After the QMS is implemented in the organization, it can carry out periodic internal audits.
The NC ISO 19011: 2007 standard should be used in this step as guidance for auditing, auditor qualification, and 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 contract 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 NC ISO 9004: 2009 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.
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