Se trata de que las actividades se planeen y se controlen de modo que se logre la mayor calidad posible para satisfacer al cliente. Cuando se publica una nueva norma, las anteriores quedan obsoletas. Por esto, las necesidades del cliente, tanto presentes como futuras, deben estar perfectamente identificadas. Documentar los procedimientos que se van a llevar a cabo en la empresa puede ser un procedimiento engorroso, pero es muy necesario ya que recoge los objetivos que se persiguen y las acciones mediante las cuales se piensan conseguir.
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The standards are available through national standards bodies. ISO deals with the fundamentals of quality management systems,including the eight management principles upon which the family of standards is based. ISO deals with the requirements that organizations wishing to meet the standard must fulfill. Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO Over a million organizations worldwide are independently certified, making ISO one of the most widely used management tools in the world today.
Thousands of organizations in over countries have adopted it, and many more are in the process of doing so. Because it controls quality. It saves money. Customers expect it. And competitors use it. ISO applies to all types of organizations. It can help both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.
It is located in Switzerland and was established in to develop common international standards in many areas. Its members come from over national standards bodies. It does not specify any requirements for product or service quality. Customers typically set product and service quality requirements. ISO requirements are complementary to contractual and applicable regulatory requirements. Those implementing a QMS conforming to ISO must ensure that the specific requirements of their customers and regulatory agencies are met.
ISO Quality management systems — Requirements: This document is the standard that defines a generic set of requirements for organizations wishing to develop a quality management system. This is the only standard to which an organization may obtain certification. Because requirements are generic and not specific, organizations have flexibility in tailoring their quality management systems to fit their business, culture and risks.
ISO Quality management systems: Guidelines for performance improvements. As the title indicates, this is a guidance document for organizations wishing to move beyond the requirements of ISO , in pursuit of continual improvement of overall business performance.
Its use is not intended for certification or contractual purposes. ISO Provides guidance on auditing quality and environmental management systems 3.
Management Responsibility — sets requirements for top management to demonstrate its leadership and commitment to develop, implement and continually improve the QMS. Measurement, Analysis and Improvement — sets requirements to plan, measure, analyze and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness.
The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable objectives. The business makes decisions about the quality system based on recorded data.
The quality system is regularly audited and evaluated for conformance and effectiveness. Records show how and where raw materials and products were processed to allow products and problems to be traced to the source. The business determines customer requirements. The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.
When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs. The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits. The business deals with past problems and potential problems.
It keeps records of these activities and the resulting decisions, and monitors their effectiveness. The business has documented procedures for dealing with actual and potential nonconformances problems involving suppliers, customers, or internal problems. The business: Makes sure no one uses a bad product; Determines what to do with a bad product; Deals with the root cause of problems; and Keeps records to use as a tool to improve the system.
For practical purposes, the difference between the two terms is not significant and both are acceptable for general use. Accreditation refers to the formal recognition by a specialized body — an accreditation body AB - that a certification body CB is competent to perform ISO certification in specified business sectors.
In simple terms, accreditation is certification of the CB. Pre-assessment Before the actual certification audit, a CB auditor makes a preliminary visit of your facilities, briefly reviews your QMS documentation and conduct an informal check of the QMS implementation. In essence, this preliminary audit intended to uncover areas in your QMS that might need special attention.
During the initial visit the audit scope and audit program is agreed upon, as well. A Pre-assessment is an optional activity. It adds value in that it provides an organization with a clear view of the gaps in its state of readiness, a few months prior to the formal certification audit. More and more organizations now prefer experienced consultant auditors to do the Pre-assessments as they not just identify the gaps, but also provide solutions to correcting them.
CB auditors may only report on the gaps, but are not allowed to provide solutions. Documentation review The CB audit team evaluates your QMS manual to determine the adequacy of its scope and conformity to the requirements of the standard.
The documentation review report summarizes any findings from this process. The report indicates if your organization is ready to proceed with the certification audit. Certification audit During the certification audit, the CB audit team conduct interviews, examinations and observations of the system in operation.
It provides the team essential information required for the certification process and assesses the degree of conformity of the QMS with the requirements of the standard. Surveillance audits Each issued certificate has a three-year life period.
Upon certification, the CB create a periodic audit schedule for surveillance audits over the three-year period. These audits confirm the on-going compliance of the QMS with specified requirements of the standard.
At least one periodic audit per year is required. Re-certification audit After the three years are up, your certification will be extended through a re-certification audit. ISO is a voluntary standard. Your organization can implement it solely for the internal benefits it brings in increased effectiveness and efficiency of your operations, without incurring the investment required in a certification programme. The ISO organization is responsible for developing, maintaining and publishing the ISO and other families of standards.
The ISO organization has no authority to control such accreditation activities. The voluntary criteria contained in these standards and guides represent an international consensus on what constitutes good practice. Their use contributes to the consistency and coherence of conformity assessment worldwide and so facilitates trade across borders. It is a powerful business tool for organizations to significantly improve the effectiveness and efficiency of their operation leading to enhanced customer satisfaction and profitability.
However, to reap the benefits of ISO , an organizations top management must adapt it as a strategic initiative in achieving its business goals. This means providing the leadership, commitment, resources, structure, policies, decision-making, culture and environment for QMS deployment and maintenance. Additionally, the standard was designed to be used as a tool for continual improvement in conjunction with technology and other business improvement tools. Improves conformity to quality requirements Increases competitive edge and market share Increasingly recognized as a requirement for contractual relationships in the global arena.
Quality has many meanings. In the quality management field, quality has a more specific meaning. Requirements that need to be fulfilled in a contractual situation typically relate to the provision of a specific product, service or intangible item such as intellectual property.
Requirements may be stated or implied. In a contractual situation, stated needs are specified in contract requirements and translated into specific product or service features, functions and characteristics with specified acceptance criteria.
Implied needs on the other hand are basic features and characteristics that are identified and defined by the manufacturer, based on knowledge of the marketplace expectations. For example, the implied characteristic of a watch is its basic ability to provide accurate time. A customer may specify some or all these characteristics.
A problem or nonconformity in any of these areas may lead to customer dissatisfaction. An organization must ensure that it has systems and controls to assure that it can consistently fulfill all these requirements and enhance customer satisfaction. The needs of customers vary and change over time. Therefore, companies should review quality requirements periodically.
Requirements may also come from regulatory, statutory, industry and other sources. An organization must be aware of and ensure that all these diverse requirements are defined and met.
An effective ISO quality management system must address all four facets of quality. The principal objective of any business is to make money and stay in business. It accomplishes this by providing a product or service that meets the demands and requirements of the marketplace. In order to ensure its share of marketplace demand, a company must ensure its ability to retain repeat business.
Customers provide repeat business to those companies that can consistently meet its quality expectations: delivery of the right product and quantity; in the right packaging; at the right time and place; at the right price; that meets requirements and satisfies the customer. Customers demand assurance that its suppliers can measure up to this expectation for consistency and will take active measures to provide this assurance.
Senior management must ensure that its management of quality — organizational structure, responsibilities, processes, documentation of processes, controls, training and resources are determined and available to the organization in order to achieve quality assurance in the manner described above. Having established what is meant by quality, some consideration must be given to the various quality management tools that are available for implementing an effective quality management system.
To apply the four tools, an organization may use the controls requirements of the ISO standard and the eight quality management principles. It also provides the objective evidence that customers seek for an effective quality management system. An organization must identify the processes, resources and controls needed to meet defined quality objectives customer and organization.
Implementación del SGC basado en la norma ISO 9001:2008 (PowerPoint)