What product documentation is needed in Russia?
Usually, for industrial and home equipment it is necessary to develop:
1. Technical specification (Технические условия (ТУ)). A technical specification is required for product conformity assessment. The technical specification contains applicable technical standards for your products. The testing laboratory and the accredited body will use the technical specification during testing and conformity assessment of products.
2. Datasheet or passport (паспорт (ПС)). Usually, the development of a passport is necessary for equipment. Its function is the same as the vehicle’s passport — the buyer must put the purchased equipment on balance. The content of the passport is regulated by the standards GOST 2.601-2013 and GOST 2.610-2019.
3. Operational manual (руководство по эксплуатации (РЭ)). The development of an operational manual is necessary for industrial and home equipment, medical equipment, and other devices and consumer products. The contents of the operational manual are also regulated by the standards GOST 2.601-2013 and GOST 2.610-2019, as well as standards for a specific type of equipment.
4. Safety justification (обоснование безопасности (ОБ)). To develop a safety justification is necessary for machinery and equipment. This is a requirement of the technical regulation ТР ТС 010/2011 «Safety of machinery and equipment». In addition, a safety justification should be developed for amusement rides. In this case, the safety justification should include a calculation of the structural steel, welded and bolted joints.
5. An electrical diagram is necessary when conducting tests for electromagnetic compatibility and assessing the electrical safety of the equipment. An electrical diagram for industrial electrical equipment must be supplied with the product.
6. Product drawings and bill of materials. Required to identify the product and to verify compliance with design requirements.
Why is quality documentation important?
For example, an operational manual is needed for both the user and the manufacturer. One of the key uses of the manual is to inform the user of the residual risks of using the product. At the same time, the manual protects the manufacturer in case of non-compliance by the user with the stated requirements: in case of violation of the warranty conditions, in case of accidents and other incidents.
If the technical specification is poorly developed and does not contain the requirements of mandatory standards, the accredited body obliges you to make changes. Conformity assessment will not be possible until all requirements of mandatory standards are met.
Cost of services (depends on the complexity of the product):
1. Technical specification: from 400 US Dollars per 1 product
2. Datasheet or passport: from 80 US Dollars per 1 product
3. Operational manual: from 300 US Dollars per 1 product
4. Safety justification: from 400 US Dollars per 1 product
5. Electrical diagram: from 300 US Dollars for 1 product
6. Engineering calculations, drawings, specifications: calculated individually
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