To pass the ISO GOST R ISO 14644 certification you need to call to expert-consulting center +7 (495) 640-41-21. Consultancy expert will help you to select the most acceptable certification-system, will instruct you about the list of necessary documents, will give you contract, will tell about the certification types, will accompany you till the moment of receiving the certificate ISO GOST R ISO 14644.
Policies by the certification (from 3 to 30 days):
1. Announce to certification
2. Making contract
3. Acquisition of documents
4. Control and analyze
5. Conformity certificate issuing
Common information about certification ISO GOST R ISO 14644.
The important document, which determines the profitability and competitive capacity of an enterprise in future and in the near years, is the construction project of a new manufacture or the project of it’s reconstruction. The project development is conducted with account of requirements and European enactments: building regulations (SNiP), GOST, non-departmental technological design standards (VNTP), EU directive.
The international GMP-standards come into account by the project development in the aerospace, pharmaceutical, food and microelectronic industry, and by the manufacturing of the diagnostic equipment, foodstuff, active ingredients and accessory food substances. This type of standards is obligatory in all mature economies.
In Russia, the analogue to GMP (Good Manufacturing Practice) in the “clean space-room” sphere, are GOST R ISO 14644 standards, developed and accepted by the technical committee ISO/TK 209 in 2002. GOST R ISO 14644 standards determine the requirements to the cleanness of the space-rooms and, connected to them., controlled environment in industrial activity branches, mentioned in the preamble of this standard.
The major factor at the plant, which can pollute the manufactured products, are the operating personnel and the composition of the air, even under the compliance with the veterinary sanitary requirements by the manufacturing, mentioned in the parts 1-7 GOST R ISO and GMP, To prevent this kind of pollution in manufacturing, will be realized the working space zonation. The space should be divided under the special parameters in two categories: “dirty” and “clean”. This zone-dividing is realized under the conditions of contented aerosol bacteria’s microparticles (microorganisms). The control of concentration of microorganisms in air is conducted obligatory and is accomplished with help of the space-constructions (the presence of the supply-extract system). Humidity, temperature and pressure control may be conducted, if necessary. (ISO 14644-1)
The designing of the clean room-spaces is to be made with account of requirements for this type of manufacturing (GOST R ISO 14644). The temperature conditions, lighting, humidity, supply and exhaust ventilation – all these parameters must conform the type of the room-space and shouldn’t influence on the work of equipment.
Depending on the purpose and stage of production, the clean room-spaces are divided into rooms of the different cleanness-type classes. By designing of such kind of the room, firstly, into account should be taken the logical order of manufacturing operations and requirements, to minimize the cross-contamination and blending of different components . For this goals are used the master manufacturing control systems with the high-level intelligence.
The main characteristics of the clean room-spaces are:
The classification of the clean room-spaces presents it’s class, which characteristic is connected with the air cleanness-grade in the room. These classification standards, depending on the industry branches, have the special characteristics. For example, the concentration of the microorganisms is to be inspected and rated in the food-manufacturing industry, pharmaceutics, in the practical medicine. On the contrary, in the microelectronic manufacturing this factor isn’t important. The classification of the clean room-space and it’s class depend on the object’s state (according to GOST ISO 14644-1-2000) and are determined by the microparticles concentration in the clean room-space or zone. The clean room-spaces can be divided in three types:
The declared cleanness-level is observed by the fair number of the executed requirements, mentioned for each clean room-space. These requirements are observed progressive.
ICO is able to:
Among goals of ICO is spreading of quality-principles in organizations, popularization of quality management-systems, knowledgeable assistance for organizations by entering a new level of business dealing.
Among the main management principles: