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Specialization >> Quality Management System

Management System (QMS) is a powerful tool that allows organizations both for profit (eg car manufacturers, Airlines ...) and nonprofit (eg Hospitals, NGOs ...) to achieve the objectives defined in statutes and increase their competitiveness in a rapidly changing environment like this.

They have identified eight principles of quality management that can be used by senior management in order to lead the organization towards improved performance.

  • Customer focus: Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
  • Leadership: Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the objectives of the organization.
  • Involvement of the staff. People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the benefit of the organization.
  • Process approach A desired result is achieved more efficiently when activities and related resources are managed as a process. Process is a set of interrelated activities or interacting activities which transforms inputs into results.
  • System approach to management: Identifying, understanding and managing interrelated processes as a system contributes to the effectiveness and efficiency of an organization in achieving its objectives.
  • Continuous improvement: Continual improvement of the organization's overall performance should be a permanent objective for it.
  • Approach based in facts to decision making: Effective decisions are based on the analysis of data and information.
  • Mutually beneficial relationships with suppliers: An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

These eight principles are the basis of Systems of Quality Management ISO 9000 family of standards.

Overview of Quality Management System according to ISO 9000 family of standards

The QMS's famiIy of standards ISO 9000 system is the most established worldwide. Its success is because it has been prepared by a panel of internationally renowned experts. The requirements of this system of quality management are generic and applicable to organizations of any economic and industrial regardless of the category of the product/service offered.

The ISO 9000 family of standards include the following standards:

  • The ISO 9000 standard describes fundamentals of management systems and specifies the terminology for the quality management systems.
  • The ISO 9001 standard specifies the requirements for systems of quality management applicable to any organization that needs to demonstrate its ability to provide products that meet customer requirements and regulatory requirements that are applicable, and aims to increase satisfaction customer.
  • The ISO 9004 standard provides guidelines that consider both the effectiveness and efficiency of quality management. The objective of this standard is to improve organizational performance and satisfaction of customers and other stakeholders.
  • The ISO 19011 standard provides guidance relative on auditing management systems for quality and environmental management.

All these rules together form a coherent set of management system standards of quality which facilitate mutual understanding in national and international trade.

The ISO 9000 family distinguishes between requirements for systems of quality management and product requirements.
The requirements for systems of quality management are specified in ISO 9001. The ISO 9001 Standard does not establish requirements for products.
The requirements for products can be specified by customers, the organization anticipating customer requirements, or regulations. The requirements for products and, in some cases, associated processes may be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements.

The QMS is reflected in a series of documents which must include:

  • Documented statements of a quality policy and quality objectives.
  • A quality manual.
  • Procedures documented and records required by this International Standard.
  • The documents, including records determined by the organization that are necessary to ensure the effective planning, operation and control of its processes.

Guide for the implementation of a QMS according to ISO 9000 family of standards

The project to implement a QMS consists of the following phases:

Diagrama de la implantación de un QMS según la familia de normas ISO 9000

Phase I: Define the project team

At this phase people and customer DiTec Consultants that will be part of the project team are identified. The project's success will depend largely on proper selection of such persons.
On the client the following persons shall be included in the team:

  • Project Leader
    It will be a representative of the senior management of the organization which exercises the leadership of the project, promoting and facilitating the activities to be carried out. It also has direct responsibility for defining the Mission, Vision and Values ??of the organization, the Policy, the Objectives and Scope of the Quality Plan and Organizational Structure of the Organization, all of which must be included in the Quality Manual that must be approved and signed by this person.
  • Quality Responsable
    It will be the person responsible for overseeing the day-to-day monitoring of the project, will be the usual contact with the designers of the QMS and will monitor and approve the documentation generated. Must have the leadership skills within the organization and have a complete knowledge of its operation.
    The management representative shall:
    • The quality responsable will ensure to establish, implement and maintain the system processes needed for quality management,
    • Reporting to top management on the performance of the system of quality management and any need for improvement, and
    • Ensure awareness of customer requirements at all levels of the organization is promoted.
  • People in the organization who can contribute their knowledge in processes, records and other relevant documentation of the organization, which is related to the QMS.

Phase II: Communicating the project and its objectives to all employees of the organization

The Quality Management System applies to all employees of the organization, which may contribute to a greater or lesser extent to the success of the project. We must communicate to all employees what the project consist and to encourage them to make their contributions through the leaders of the organization.

The employees of an organization often view the QMS increases the internal bureaucracy, providing little added value. Internal communication of the project should aim to demonstrate that the QMS actually promotes:

  • The improvement of all organizational processes
  • Increased employee contributions to organizational results
  • Better screening of his professional life
  • The improvement in the labour environment
  • More fluent relationships with customers and suppliers
  • Improving relations with the organization of society in general
  • An improvement of the overall results of the organization that is in the benefit of all parties

Phase III: Get the most relevant information of the company

The changes are usually not well accepted by the parties concerned, therefore whenever the existing documentation meets the requirements of ISO standards, should join the QMS.

Specifically, it should incorporate the description of processes, records and other documentation already held by the organization which also facilitates the implementation of the QMS.

Customer should be noted that this documentation will be treated as completely confidential and will not be used for other purposes outside the project.

Phase IV: Developing the QMS documentation

The QMS documentation basically consists on:

  • Quality Manual
    This document specifies the management system of the quality of an organization. Quality manuals can vary in detail and format to suit the size and complexity of each individual organization.
    Its content include:
    • Introduction and History of the organization; Mission , Vision and Values??, Policy , Objectives and Scope of the QMS; Organization Chart, Process Map and relationships.
    • Purpose and scope; Scope, Responsibilities, Distribution - Assignment of copies; Revision control.
    • General requirements ; Documentation requirements : Generalities, Quality Manual, Control of documents and Control of records
    • Management Responsibility: Management Commitment, Customer Focus, Quality Policy, Planning, Responsibility, Authority and Communication and Management Review.
    • Resource management: Provision of Resources, Human Resources, Infrastructure and Labour Environment
    • Product Realization : Planning of product realization, processes related to the Client , Design and Development, Purchasing, Production and product control and monitoring equipment and measurement processes
    • Measurement, Analysis and Improvement: Generalities, Monitoring and Measurement, Control of nonconforming product, Data Analysis and Improvement

  • Procedures
    Documents that specify how to carry out an activity or process. The ISO 9001 standard considers essential performing the following procedures:
    • Document Control Procedure
    • Records Control Procedure
    • Procedure and Records for the Internal Audits Program
    • Procedure and Records Control of nonconforming product
    • Procedure and Records for the Control of Corrective and Preventive Actions.

    The QMS must be implemented other procedures that are relevant to the development of their activities, eg Assessment Procedure and Customer Satisfaction.

  • Records
    Documents showing results or providing evidence of activities performed. The ISO 9001 standard considers indispensables the records relating to: Internal Audit, Control of nonconforming products and control of preventive and corrective actions.
    The QMS must implement other records relevant to the development of their activities, eg Records of evaluation of suppliers of products purchased.

Phase V: Periodic follow-up meetings

These periodic monitoring meetings are intended to obtain additional information on the processes and customer documentation, verify that the documents are being generated QMS meet customer expectations and get partial approval, and ensure that the project does not deviate in term.
Depending on the subjects to be treated, the meetings may be held with the project leader responsible for the quality or other persons designated by the customer.

Phase VI: Delivering Customer documentation and validation

After the development of the QMS documentation shall be delivered to the client for review and final approval, prior to the certification step.

Phase VII: Formation and Internal Audit

Before starting the procedures for certification, it must been checked that the client's employees have been informed and trained in the QMS.
Moreover, through an internal audit can be assessed the degree of compliance with the requirements of the recently implemented QMS. Internal audit can be performed using a questionnaire that explores each of the requirements of the standard, e.g.:

  • Are the processes of the system identified?
  • Can be identified and controled the processes outsourced externally?
This methodology for internal audit ensures that the QMS meets the requirements of the standard.

Phase VIII: Certification

The certification of an organization according to the ISO 9000 family of standards are available after an authorized certification organization carries out the corresponding certification named "third party". This organization must be neutral and meet the requirements of independence, impartiality, competence and integrity by certifying agency testifies that the system meets the requirements of the standards.

In Spain, the National Accreditation Entity (ENAC) is the organization responsible for issuing the permits of certification for companies. The following Internet address ENAC can be found in a list of accredited companies such certification: http://www.enac.es/web/enac/acreditados

The next step is to contact some of the certification companies to solicit bids.

Phase IX : System Maintenance and Continuous Improvement

The QMS needs to be maintained by qualified personnel to verify that it is constantly updated with changes that may occur in the organization, eg changes in processes, etc.
Additionally, the ISO 9000 standards recommend the application of the methodology known as "Plan-Do-Check-Act" (PDCA) which allows continuous improvement of the organization.
PDCA can be described as:

  • Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and policies of the organization.
  • Do: implement the processes.
  • Check: monitor and measure processes and products against policies, objectives and requirements for the product and report the results.
  • Act: take actions to continually improve process performance.

The QMS Maintenance and actions related to continuous improvement can be made ??with the human resources of the Customer or can be outsourced to DiTec.

Presentation of a Quality Integrated Management System according to family of ISO 9000 and Environmental ISO 14001

Organizations of all kinds are increasingly concerned with achieving and demonstrating solid environmental performance by controlling the impacts of their activities, products and services on the environment. Many organizations have undertaken reviews or audits to assess their environmental performance. To be most effective it is necessary that environmental actions are carried out within a management system that is integrated into the organization.

The ISO organization proposes the standard ISO 14001:2004 to implement the Environmental Management System in an organization. This international standard requires the organization to:

  • Establish an appropriate environmental policy.
  • Identify the environmental aspects arising from activities, products and services, past, existing or planned by the organization, and identify significant environmental impacts.
  • Identify applicable legal requirements and other requirements to which the organization subscribes.
  • Identify priorities and set appropriate environmental objectives and targets.
  • Establish a structure and one or more programs to implement the policy and achieve objectives and goals.
  • Facilitate planning, control, monitoring, corrective and preventive actions, auditing and review activities to ensure that the policy is complied with and that the environmental management system remains appropriate.
  • Be adaptable to changing circumstances.

The annex A of ISO 9001:2008 shows the correspondence between this standard and the ISO 14001:2004 standard which facilitates the development of an Integrated Management System for Quality and Environment.

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Latest Version: 15 / 02 / 2011