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QA/QC (Quality Assurance and Control) standards and procedures
Introduction
ISO 9000 is a set of quality control and quality management standards, established by the International Organization for Standardization (ISO). They can be applied in any type of organization or activity aimed at the production of goods or services. The standards include both the minimum content and the specific implementation guides and tools as well as the audit methods.
ISO 9000 specifies the way in which an organization operates its quality standards, delivery times and service levels. There are more than 20 elements in this ISO standards that relate to the way systems operate.
Advantages
Its implementation, although it involves hard work, offers numerous advantages for companies, such as:
History
Standardization with a systematic and scientific basis of operation was born at the end of the century, with the Industrial Revolution, due to the need to produce more and better. But the definitive boost came with the First World War (1914-1918). Given the need to supply armies and repair weapons, it was necessary to use private industry, which required specifications of interchangeability and precise adjustments. It was born to limit the uneconomic diversity of components, parts and supplies, and promote their interchangeability, facilitating mass production, repair and maintenance of products and services, as well as facilitating external relations between countries that need standard parts, and offering guarantees of compliance with customer requirements.
On December 22, 1917, the German engineers Naubaus") and Hellmich, constituted the first body dedicated to standardization: NADI - Normenausschuß der Deutschen Industrie - Committee for the Standardization of German Industry. This body began to issue standards under the acronym: DIN, which stood for Deutsche Industrie Norm.
(German Industry Standard). In 1926 the NADI changed its name to: DNA - Deutscher Normenausschuß - Committee for German Standards, which although it continued to issue standards under the acronym DIN, these came to mean "Das Ist Norm" - This is a standard. And more recently, in 1975, it changed its name to: DIN - Deutsches Institut für Normung - German Institute for Standardization.
QA/QC (Quality Assurance and Control) standards and procedures
Introduction
ISO 9000 is a set of quality control and quality management standards, established by the International Organization for Standardization (ISO). They can be applied in any type of organization or activity aimed at the production of goods or services. The standards include both the minimum content and the specific implementation guides and tools as well as the audit methods.
ISO 9000 specifies the way in which an organization operates its quality standards, delivery times and service levels. There are more than 20 elements in this ISO standards that relate to the way systems operate.
Advantages
Its implementation, although it involves hard work, offers numerous advantages for companies, such as:
History
Standardization with a systematic and scientific basis of operation was born at the end of the century, with the Industrial Revolution, due to the need to produce more and better. But the definitive boost came with the First World War (1914-1918). Given the need to supply armies and repair weapons, it was necessary to use private industry, which required specifications of interchangeability and precise adjustments. It was born to limit the uneconomic diversity of components, parts and supplies, and promote their interchangeability, facilitating mass production, repair and maintenance of products and services, as well as facilitating external relations between countries that need standard parts, and offering guarantees of compliance with customer requirements.
On December 22, 1917, the German engineers Naubaus") and Hellmich, constituted the first body dedicated to standardization: NADI - Normenausschuß der Deutschen Industrie - Committee for the Standardization of German Industry. This body began to issue standards under the acronym: DIN, which stood for Deutsche Industrie Norm.
(German Industry Standard). In 1926 the NADI changed its name to: DNA - Deutscher Normenausschuß - Committee for German Standards, which although it continued to issue standards under the acronym DIN, these came to mean "Das Ist Norm" - This is a standard. And more recently, in 1975, it changed its name to: DIN - Deutsches Institut für Normung - German Institute for Standardization.
Other national committees quickly began to emerge in industrialized countries, thus in France, in 1918 the French Association for Standardization (AFNOR) was established. In 1919 in England, the private organization British Standards Institution (BSI) was established.
Given the appearance of all these national standardization organizations, the need arose to coordinate the work and experiences of all of them. With this objective, the International Federation of the National Standardizing Associations – ISA was founded in London in 1926. After the Second World War, this organization was replaced in 1947 by the International Organization for Standardization - ISO - International Organization for Standardization. Based in Geneva, and dependent on the UN.
This family of standards appeared in 1987, based on the British standard BS 5750 of 1987, experiencing its greatest growth from the 1994 version.
The main standard of the family is ISO 9001:2015: Quality Management Systems - Requirements.
Another binding standard to the previous one is ISO 9004:2009") - Quality Management Systems - Guidelines for performance improvement.
The 1994 ISO 9000 standards were mainly aimed at organizations that carried out production processes and, therefore, their implementation in service companies posed many problems. This fostered the idea that they are excessively bureaucratic rules.
With the 2000 revision, a less complicated standard was achieved, suitable for organizations of all types, applicable without problems in service companies and even in the Public Administration, in order to implement it and subsequently, if they decide, be certified in accordance with the ISO 9001 standard.
The previous version, published on November 13, 2008, was replaced by the current version, which was published on September 23, 2015.[1].
Certification
Contenido
La única norma de la familia ISO 9000 que se puede certificar es la ISO 9001:2015.
Para verificar que se cumplen los requisitos de la norma, existen unas entidades de certificación, conocidas como consultorías de certificación ISO que auditan la implantación y aplicación, emitiendo un certificado de conformidad. Estas entidades están vigiladas por organismos nacionales que regulan su actividad.
Para la implantación o preparación previa, es muy conveniente que apoye a la organización una empresa de consultoría, que tenga buenas referencias, y el firme compromiso de la Dirección de que quiere implantar el Sistema, ya que es necesario dedicar tiempo del personal de la empresa para implantar el Sistema de gestión de la calidad.
Certification Process
In order to be certified to ISO 9001 (the only certifiable standard in the series), organizations must choose the scope to be certified, the processes or areas they wish to involve in the project, select a record, undergo the audit and, upon successful completion, undergo an annual inspection to maintain certification.
The requirements of the standard are generic, since they must be applicable to any company, regardless of factors such as: size, activity, clients, planning, type and style of leadership, etc. Therefore, the "what" is established in the requirements, but not the "how." An implementation project involves the company developing specific criteria and applying them, through the QMS, to the company's own activities. By developing these criteria consistent with its activity, the company builds its Quality Management System.
In the event that the auditor finds areas of non-compliance, the organization has a period of time to adopt corrective measures, without losing the validity of the certification or continuity in the certification process (depending on whether or not it had already obtained certification).
An implementation project will involve, at a minimum:
Other national committees quickly began to emerge in industrialized countries, thus in France, in 1918 the French Association for Standardization (AFNOR) was established. In 1919 in England, the private organization British Standards Institution (BSI) was established.
Given the appearance of all these national standardization organizations, the need arose to coordinate the work and experiences of all of them. With this objective, the International Federation of the National Standardizing Associations – ISA was founded in London in 1926. After the Second World War, this organization was replaced in 1947 by the International Organization for Standardization - ISO - International Organization for Standardization. Based in Geneva, and dependent on the UN.
This family of standards appeared in 1987, based on the British standard BS 5750 of 1987, experiencing its greatest growth from the 1994 version.
The main standard of the family is ISO 9001:2015: Quality Management Systems - Requirements.
Another binding standard to the previous one is ISO 9004:2009") - Quality Management Systems - Guidelines for performance improvement.
The 1994 ISO 9000 standards were mainly aimed at organizations that carried out production processes and, therefore, their implementation in service companies posed many problems. This fostered the idea that they are excessively bureaucratic rules.
With the 2000 revision, a less complicated standard was achieved, suitable for organizations of all types, applicable without problems in service companies and even in the Public Administration, in order to implement it and subsequently, if they decide, be certified in accordance with the ISO 9001 standard.
The previous version, published on November 13, 2008, was replaced by the current version, which was published on September 23, 2015.[1].
Certification
Contenido
La única norma de la familia ISO 9000 que se puede certificar es la ISO 9001:2015.
Para verificar que se cumplen los requisitos de la norma, existen unas entidades de certificación, conocidas como consultorías de certificación ISO que auditan la implantación y aplicación, emitiendo un certificado de conformidad. Estas entidades están vigiladas por organismos nacionales que regulan su actividad.
Para la implantación o preparación previa, es muy conveniente que apoye a la organización una empresa de consultoría, que tenga buenas referencias, y el firme compromiso de la Dirección de que quiere implantar el Sistema, ya que es necesario dedicar tiempo del personal de la empresa para implantar el Sistema de gestión de la calidad.
Certification Process
In order to be certified to ISO 9001 (the only certifiable standard in the series), organizations must choose the scope to be certified, the processes or areas they wish to involve in the project, select a record, undergo the audit and, upon successful completion, undergo an annual inspection to maintain certification.
The requirements of the standard are generic, since they must be applicable to any company, regardless of factors such as: size, activity, clients, planning, type and style of leadership, etc. Therefore, the "what" is established in the requirements, but not the "how." An implementation project involves the company developing specific criteria and applying them, through the QMS, to the company's own activities. By developing these criteria consistent with its activity, the company builds its Quality Management System.
In the event that the auditor finds areas of non-compliance, the organization has a period of time to adopt corrective measures, without losing the validity of the certification or continuity in the certification process (depending on whether or not it had already obtained certification).
An implementation project will involve, at a minimum: