1. A bit of history
The quality infrastructure and Industrial Safety begins in Spain with the publication of the Industry Law (Law 21/1992 BOE of July 23, 92), however, the development of said Law occurs with the publication of RD 2200 / 95 (BOE 6 February 96) and the Quality and Industrial Safety infrastructure in Spain is established.
With this Royal Decree the way of acting of all the certification, inspection and test laboratories of the member countries of the EEC is standardized.
1.1. The industry law; some concepts
- Standard: Technical specification of continuous application whose observation is not mandatory, established with the participation of all interested parties, which is approved by a recognized body, at the national or intentional level, for its standardizing activity. Technical Regulation: technical specification related to products, processes or industrial facilities, established with a Mandatory nature through a provision, for their manufacture, commercialization or use. Standardization: activity by which criteria are unified in relation to certain subjects and the use of a common language is made possible in a specific field of activity. Test: operation consisting of the examination or verification of one or more properties of a product, process or service according to a specified procedure. Certification: Activity that allows establishing the conformity of a certain company, product, process or service with the requirements defined in standards or technical specifications Homologation: certification by a Public Administration that the prototype of a product meets the regulatory requirements Inspection: activity by The one that examines designs, products, processes, facilities and services to verify compliance with the requirements that apply to it. Control organism: entities that carry out certification, inspection, testing or calibration activities, in the regulatory field of industrial safety. Accreditation: formal recognition of the technical competence of an entity to certify, inspect or audit or carry out testing or calibration activities Calibration: activities that aim to establish the relationship between the values indicated by a measurement device and the corresponding known values to a measurand. Quality: Set of properties of a product or service that give it the ability to satisfy the expressed or implicit needs of a customer. Quality System: set of the structure, responsibilities, activities, resources and procedures of the organization of a company that it establishes to carry out Quality management. Quality Audit: systematic and independent examination of the effectiveness of a quality system or one of its parts.
2. Standardization
Product users demand "almost perfect" products and services, manufacturers have to produce them with the highest safety requirements, but with strictly economic criteria, which is why the interests of users and manufacturers do not always converge.
It is therefore necessary to reach an agreement is achieved through standardization.
Standardization is a pact that is included in a technical document through which manufacturers, consumers, users and the administration agree on the characteristics that a product or service must have.
2.1. Technical committees.
The technical committees that draft the standards are made up of:
- Users through their organizations and individually Manufacturers through their sectoral organizations or as a company Consumers represented by their associations Public Administrations in order to ensure the interests of citizens Laboratories and centers of Research providing technical opinions Professionals through professional associations and associations.
2.2. The rationale behind standardization
- Simplify: it seeks to control, unify and simplify products. Communicate: the standards must take into account the interests of all the parties that need it for the exchange of ideas Economize production: through rationalization and optimization of production processes, the aim is to make the technical aspects of the standards compatible with the achievement of economic advantages for producer and consumer. Safety: almost all regulations refer to aspects of safety, health or environmental protection. Elimination of trade barriers: the existence, knowledge and application of standards facilitates the trade of products that conform to national or international standards of general acceptance.
2.3. Advantages of standardization
- For consumers: it sets levels of quality and safety of products, they reveal benefits and facilitate comparison with other similar ones. For the Administration: They can control technical documents that facilitate the legislation. For manufacturers: They reduce product varieties, lower production costs, improve management and design, eliminate technical barriers and facilitate commercialization.
3. The rules
3.1. Types of standards
There are three types of standards: the international ISO; European EN and national ones: UNE (Spain), DIN (Germany), BS (British), ANSI (American), etc.
The ISO standards are created by the International Standardization Organization through its technical committees and restrained by its members. They are international standards that are followed by all countries that recognize ISO.
The EN standards are created by CEN / CENELEC (European Committee for Standardization). The European Commission, within the Policies of the New Approach, entrusts it with the elaboration of European standards on which the member states and community directives will be based.
National standards are transpositions of ISO, EN standards or standards drawn up by the national standardizing body (AENOR in Spain, BENOR in Belgium, AFNOR in France, etc.) in sectors where there is no standard.
3.2. Origin of the rules
Standards can follow an ascending or descending path for their elaboration.
One way is the creation by ISO of a standard, for example ISO 14001. In this case, the ISO member countries undertake to transpose it within a specified period. It will first be transposed to an EN standard and then to a national standard, so that at the end of its journey it will be a UNE-EN-ISO 14001: 2004. This name indicates that this standard has a range of international, European and national standards
As the transposition process can be long, countries can issue a specific series of said standard such as ISO or EN, this was the case of UNE 66900, which was the name by which the ISO 9000 series of standards was known in Spain.
The process can be reversed if a member state develops a new sector standard. This standard would be studied at the CEN and if it is correct and achieves the agreement of the parties, it will become an EN standard. If you then go to ISO and the same process is repeated there, it will become an ISO standard.
The standards are drawn up by the ISO, CEN / CENELEC or AENOR Technical Committees, in which the different users, manufacturers and Administrations are represented.
4. Outstanding aspects of RD 2200/95
4.1 The new approach
In May 1985 a resolution of the EEC gave rise to the birth of “Nuevo
Focus". This policy is completed with the Conformity Assessment tools that are approved in a resolution dated December 21, 1989.
The new approach consists of the progressive replacement of the national regulations of the EU member states by the application of EN Standards.
From this moment on, the Community directives begin to refer to Standards that include the characteristics related to the safety and quality of the products. In other words, standardization is taken as a reference for the development of national regulations and administrative approval is replaced by the use of conformity assessment instruments.
At the same time, accreditation is established as a tool to guarantee the proper functioning of the markets, in order to obtain a sufficient degree of confidence in the certificates issued anywhere in Europe. This should allow the free movement of products within the EU without the technical barriers that were previously imposed by national regulations.
In addition to this, entities such as testing and calibration laboratories operating in mandatory and voluntary fields will be able to demonstrate their technical competence, independence and capacity.
4.2. Agents subject to accreditation
- Agents who act in the mandatory scope of Industrial Safety (Environmental Control Organizations and Verifiers) may not act without having been accredited by ENAC. Agents who act in the voluntary sphere of quality are not obliged to accreditation although, if they want to voluntarily be included in the Quality Infrastructure, they will require accreditation.
4.3. Common infrastructure for quality and industrial safety.
- Standardization Bodies (in Spain AENOR is designated) with the task of developing standards. Accreditation Bodies (in Spain ENAC) with the task of carrying out the formal recognition of the technical competence of an entity to certify, inspect or audit quality, or a test or calibration laboratory and verify compliance with the conditions at the state level by OCAs (Authorized Control Bodies, for example ITVs) and environmental verifiers.
4.4. Creditable infrastructure for quality
- Certification bodies: they have the task of establishing the conformity of a company, product, process or person with the requirements of a standard or technical specification. Industrial laboratories: they have the task of verifying that industrial products comply with the applicable standards or technical specifications. Auditing and Inspection Entities: have the task of determining whether the activities and the results related to Quality satisfy the previously established requirements, if these requirements are carried out effectively and are capable of achieving their objectives. Industrial Calibration Laboratories: They have the task of facilitating the traceability and uniformity of the measurement results.
4.5. Creditable infrastructure of industrial security.
- The Control Bodies: have the task of carrying out in the regulatory field, in matters of industrial safety, certification, inspection, testing and auditing activities. Environmental verifiers: they have the task of examining the policies, programs, management systems, evaluation and auditing procedures and declarations regarding the industrial environment, as well as carrying out the validation of these.
Contributed by El Rincón del Gerente
