ISO 9000 standards

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 oriented to the production of goods or services. The standards include both the minimum content and the specific implementation guides and tools, such as 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 the standards of this ISO that relate to the way systems operate.

Description

8 Principles of Quality Management (updated ISO 9000-2000)

1.-Customer focus

2.-Leadership

3.-Commitment of people

4.-Process-based approach

5.-Improvement (Continuous improvement)

6.-Evidence-based decision making

7.-Relationship management: (Our customers expect that what is promised is delivered with quality and in accordance with the requirements established in advance, so it is necessary for our suppliers to have a system quality management to guarantee it).

8.- Personal participation: (That everyone is committed to participating laborally in the company or branch)

Advantages

Its implementation, although it involves hard work, offers numerous advantages for companies, such as:

• Standardize the activities of staff working within the organization through documentation.
• Increase customer satisfaction by ensuring the quality of products and services consistently, given the standardization of procedures and activities.
• Measure and monitor the performance of the productive, distributed and administrative processes of the products.
• Increase the effectiveness and efficiency of the organization in achieving its objectives.
• Continued improvement in processes, products, efficiency, among others.
• Reduce negative incidences of production or service delivery.
• Keep the quality.

Disadvantages

• Efforts and costs to prepare the documentation and implementation of the systems.

History

Standardization with a systematic and scientific basis was born at the end of the 19th century, with the Industrial Revolution, given the need to produce more and better. But the definitive impulse came with the First World War (1914-1918). Faced with the need to supply armies and repair weapons, it was necessary to use private industry, which required interchangeability specifications and precise adjustments. It was born to limit the uneconomical diversity of components, parts and supplies, and favor 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. compliance with customer requirements. On December 22, 1917, the German engineers Naubaus and Hellmich set up the first body dedicated to standardization: NADI - Normenausschuß der Deutschen Industrie - German Industry Standardization Committee. This body began to issue standards under the acronym: DIN which stood for Deutsche Industrie Norm (German Industry Standard). In 1926 NADI changed its name to: DNA - Deutscher Normenausschuß - German Standards Committee, which, although it continued to issue standards under the acronym DIN, these came to mean "Das Ist Norm" - This is 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, such as in France, in 1918 the French Association for Standardization (AFNOR) was established. In 1919, the private organization British Standards Institution (BSI) was established in England. 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 World War II, this body 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 standard binding to the previous one is ISO 9004:2009 - Quality Management Systems - Guidelines for performance improvement.

The ISO 9000 standards of 1994 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 kinds, applicable without problems in service companies and even in the Public Administration, in order to implement it and later, if they decide, to be certified in accordance with ISO 9001.

The previous version, published on November 13, 2008, was superseded by the current version, which was published on September 23, 2015.

Certification

The only ISO 9000 family standard that can be certified is ISO 9001:2015.

To verify that the requirements of the standard are met, there are certification entities that audit the implementation and application, issuing a certificate of conformity. These entities are supervised by national bodies that regulate their activity.

For the implementation or previous preparation, it is very advisable that a consulting company support the organization, which has good references, and the firm commitment of the Management that they want to implement the System, since it is necessary to dedicate staff time of the company to implement the Quality Management System.

Certification Process

In order to be certified according 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 requirements establish the "what", 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 term 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 the certification). certification).

An implementation project will involve, as a minimum:

• Understand and know the normative requirements and how they reach the activity of the company.
• Analyze the situation of the organization, where it is and where it should come from.
• Building a Quality Management System from each step.
• Document processes that are required by the norm, as well as those that the company's own activity requires.

The rule requests that procedures relating to: management and written control, quality records, internal audits, non-conforming product, corrective actions and preventive actions be documented.

• Detect the company's own training needs.

During the implementation of the project, it will be necessary to train staff in terms of quality policy, aspects related to quality management that assists them in understanding the contribution or incidence of their activity to the product or service provided by the company (in order to generate commitment and awareness), providing internal audit tools for those who perform in that position.

• Conduct Internal Audits.
• Use the Quality System (SGC), record its use and improve it for several months.
• Request the Certification Audit.

Classification

ISO standards are classified into:

• ISO 9000 (full vocabulary)
• ISO 9001 (management system model)
• ISO 9003 (model for production): This standard is cancelled by ISO 9001:2000, the current version being ISO 9001:2015.
• ISO 9004 (directive to improve performance)