Quality management system according to ISO 9000
1. Implementation of a Quality Management System.
The ISO 9000 Standards take their name from the institution “International Organization for Standardization”, the world's leading standardization body, which made it possible to approve the texts of the standards that make up this series.
The 9000 series focuses on documentation standards, in particular the Quality Management Manual, in order to ensure that appropriate Quality Management Systems are in place. The development of these manuals requires a methodology, knowledge and organizational criteria to collect the characteristics of the company's process.
The application of the ISO 9000 Quality Standards constitute a way for the industry to reduce costs and improve its production processes, taking into account that quality is a key factor for competitiveness in any market. The person who is dedicated to standardizing must be knowledgeable about this task, thus guaranteeing the incorporation of a procedure that adapts to the reality of the process, that is useful and easy to understand.
As companies become increasingly interdependent across international borders, there will be increasing pressure to ensure the quality of processes. In such an environment, there is a considerable set of international standards, and a single international organization making the effort to try to promote them.
The development and commercialization of products cannot continue to be considered locally, as external competition attacks with international quality and costs, thus appearing the world-class company, capable of competing in any market with the best in its field.
In view of this globalization and the knowledge that a Quality Management System in operation creates the basis for taking decisions "based on knowledge", an optimal understanding between the "interested parties" and above all achieving an increase in the success of the company through the reduction of costs due to failures (hidden costs) and losses due to friction; Companies in favor of improving the performance of their organization must start the Implementation of the Quality Management System based on: Customer focus, leadership, staff participation, process-based approach, management based in systems, continuous improvement, fact-based decision making and mutually beneficial relationship with the supplier.
To begin with the Implementation of a Quality Management System, the Analysis of the Work Processes is necessary; A useful tool for such a function is the process structure or Process Map.
The Process Map of an organization allows considering the way in which each individual process is linked vertically and horizontally, their relationships and interactions within the organization, but above all also with stakeholders outside the organization, thus forming the process general of the company.
This process orientation requires subdivision into individual processes, taking into account the strategies and objectives of the organization. Experience has shown that it is convenient to define the input data, control parameters and output data.
Once the structure of the processes has been defined, the System is documented, elaborating or improving the Procedures and Instructions; For this, the Documentation Structure of the Quality System is considered.
As represented by the Documentation Pyramid, the Implementation of the Quality Management System begins with the 3rd. Level, the collection of plans, instructions and records that provide technical details on how to do the work and record the results, these represent the fundamental basis of documentation.
Subsequently, the information specified on the procedures of each area of Management was determined: Who? What? How? When? Where? and because? carry out the activities (2nd. Level), this in order to generate the Procedures Manuals for each area.
The documented procedures of the quality management system must form the basic documentation used for the general planning and management of the activities that have an impact on quality, they must also cover all the applicable elements of the quality management system standard. Said procedures must describe the responsibilities, authorities and interrelationships of the personnel who manage, carry out and verify the work that affects quality, how the different activities must be carried out, the documentation that must be used and the controls that must be applied.
Some of the main objectives pursued with the elaboration of the procedure manuals are:
• Communicate the quality policy, procedures and requirements of the organization.
• Train and / or train new employees.
• Define responsibilities and authorities.
• Regulate and standardize the activities of the Company.
• Facilitate the introduction of a better method by giving complete data on the current method.
• Helps establish better programs of operations and activities.
• Provide the documentary bases for the audits.
In addition, the management must execute the 1st. Level; the elaboration of the Quality Policy and the Objectives.
2. Structure for the Rising of each Procedure and Work Instructions
A recommended structure for the lifting of each procedure and work instructions is the following:
Procedures:
Document Title and Approval
Record of revisions made to this document
1. Objective
2. Reach
3. Responsible
4. Conditions / Regulations
5. Description of Activities
6. Flow chart
7. Reference Documents
8. Records
9. Glossary
10. Annexes (includes forms and records)
Work instructions:
Document Title and Approval
Record of revisions made to this document
1. Objective
2. Reach
3. Responsible
4. Conditions / Regulations
5. Description of Activities
6. Reference Documents
7. Records
8. Glossary
9. Annexes (includes forms and records)
Each of these points will be described below:
Title and Approval of the Document.
It is the first page of the procedure or work instructions, it has the following fields: Logo and Name of the Company, Serial, Review, Pages, Signature of the person responsible for the review and approval, Name of the Procedure or Work Instructions.
Record of revisions made to this document.
It is the part of the Procedure or Work Instructions where the number of revisions made to the Document is indicated.
1. Objective.
It must clearly describe the "Why" and "What" of the procedure or work instruction, focusing on those aspects that make it unique. It must be understood and understandable by all those involved in it, as well as by all those who handle the document.
2. Reach.
It must indicate both the areas and the situations where the procedure or work instruction must be used, in addition to making its exceptions (that is, what it excludes). It must be understood and understandable both by those involved in it, and by all those who handle the procedure or work instruction.
3. Responsible.
The position (s) must be indicated, who have the responsibility of executing the activities described in the document and those responsible for its compliance, only positions should be mentioned and never referred to personally.
4. Conditions / Regulations.
Regulations: Must describe the specific conditions for the procedure or work instruction to be executed.
Security aspects: Shows the risks, measures and security implements that must be considered for the execution of the document.
Materials, Tools and equipment.
5. Description of the Activities.
It describes in detail and in chronological order the activities that must be carried out to ensure the quality of the products and / or services that are expected to be obtained.
6. Flow chart.
It must indicate in a logical way, the sequence in which the steps must be executed, the position that must be executed and the records that must be prepared for the assurance of the quality, of the products and / or services that are expected to be obtained with the procedure. Applies only for procedures. The icons used to prepare the flow chart can be seen below:
7. Reference Documentation.
You must mention all those documents, standards, books, articles, etc. that were used to develop the procedure or work instruction, and also those that should be used during the execution of the steps. This reference must indicate type, serial, title, author, edition and page, but must refer to how and where to locate it. In cases where it is difficult to access, and that is necessary to carry out some of the steps described, a copy of it must be provided as an annex to the procedure.
8. Records.
Lists the numbers and names of the forms, reports and screens associated with the process that are used for the monitoring of the activities and for the review and test necessary for the quality assessment.
9. Glossary.
It refers to the terms and / or abbreviations used in the text of the document.
10. Annexes.
It refers to the set of documents associated with the process.
1. Steps to develop a procedure manual.
To develop a procedure manual, the following steps are followed:
1. Induction by the COMPANY to the personnel involved.
b. The personnel involved collect the information, moving to the work area, different interviews were carried out with the workers to obtain a description of the activities carried out in the execution of each procedure, then the drafts are prepared following a guideline.
c. The Coordination receives the drafts and reviews to issue observations according to guidelines.
d. Once the observations have been made, the coordination codes the document, according to the Structure of the Documentation Serials and transcribes it as "Document under review, subject to modifications."
and. The coordination sends the structured procedure to the user for discussion and approval.
F. The Coordination after the approval of the user approves, edits and processes distributions to the areas of interest.
The prepared draft follows the technique of the libretto, which consists of sequentially presenting "who" does "what" activity; basically this technique that is composed of two parts:
• The actor, name of the position held by the person.
• The description of the activity carried out by each actor, starting with a present imperative verb (Make, perform, open, etc.). indicating instruction.
Once the procedures and work instructions of the company have been elaborated or improved, we proceed with the Preparation of the first draft of the Quality Manual, for this preparation the ISO 9000, 9001 and 9004: 2000 Standards are used. These standards outline the manual as follows:
1. Introduction.
1. Scope and field of application.
2. Table of contents.
3. Introductory Information.
4. Edition And Date Of The Quality Manual.
5. Update And Control Of The Quality Manual.
2. Quality Policy and Objectives related to Quality.
1. Quality Policy.
2. Dissemination and Implementation of the Quality Policy.
3. Quality Objectives.
3. Description of the Organization, Responsibility and Authority.
1. Description of the Organization.
2. Functioning of the Quality Management System.
3. Responsibility and Authority.
4. Quality Management System.
1. General Requirements.
2. Documentation Requirements.
5. Responsibility of the Management.
1. Commitment of the Management.
2. Customer focus.
3. Quality Policy.
4. Planning.
5. Responsibility, Authority and Communication.
6. Review by Management.
6. Resource Management.
1. Provision of Resources.
2. Human Resources.
3. Infrastructure.
4. Work Environment.
7. Product Realization.
1. Planning of Product Realization.
2. Customer Related Processes.
3. Design and Development.
4. Shopping.
5. Production and Service Provision.
6. Control of Monitoring and Measurement Devices.
8. Measurement, Analysis and Improvement.
1. Generalities.
2. Monitoring and Measurement.
3. Control of Non-Conforming Product.
4. Data Analysis.
5. Improvements.
9. Definitions.
10. Appendix for supporting information.
Next, the company must contact the certifying body, in (Venezuela this body is called FONDONORMA), to know the guidelines required for certification.
Subsequently, the work team in charge of standardization reviews the manual and approves it, continues with internal quality audits and applies corrective actions, all within a period of time that allows them to check the consistency of the system. Management performs its review.
After correcting the deficiencies and re-evaluating, the certifying body is contacted to carry out the external audit, from the results of the same the deficiencies are corrected to achieve certification.
Once the company is certified, continuous improvement must be sought through internal audits, corrective actions, management reviews and constant supervision audits and, of course, external audits by the certifying body.
Bibliography.
• COVENIN-ISO 9000: 2000 standards. Quality management system. Fundamentals and Vocabulary.
• COVENIN-ISO 9001: 2000 standards. Quality management system. Requirements.
• COVENIN-ISO 9004: 2000 standards. Quality management system. Recommendations for performance improvement.
• Rodríguez Cumare, Wilma. (2000). ISO 9000 Series, Support Material. Industrial Engineering Students Congress, Caracas-2000.
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