欧亚联盟EAEU、俄罗斯、乌兹别克斯/哈萨克斯坦/白俄罗斯/乌克兰医疗器械和药品注册咨询服务
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EAC certification schemes :1C,2C,3C,4C,5C,6C,7C,8C,9C
For the most
flexible and effective application of the Technical Regulations of the Customs
Union, it is necessary that the regulations take into account the specific
situation, as much as possible adapting to it the system for confirming
compliance with the requirements of the CUTR. For this, there are certification
schemes for products - a kind of product classifier.
The procedure for
obtaining a certificate of conformity may include several ways to determine the
good quality of the product and the reliability of the manufacturer:
certification
of quality management system;
laboratory
testing of product samples;
periodic
quality control;
capacity
inspection.
However, it is far
from being possible to use all forms of control for all product categories. For
example, for an imported product, production control in normal mode is not
applicable. And for a small single batch of goods it is impossible to establish
periodic supervision. This measure is only suitable for serial production. All
these nuances take into account the certification schemes of TR CU, the essence
of which lies in the combination of quality assurance forms. Total schemes
nine. And they affect not only the scope of expertise. The period of validity
of the certificate also depends on what scheme it was issued.
1C
The scheme is
intended for commercially available products. The goods must be produced on the
territory of the Customs Union. The list of actions to confirm compliance is as
follows:
- laboratory
examination of the samples submitted by the applicant;
- revision of
production capacity;
- periodic
inspection in the form of sample testing or monitoring of production.
The applicant can
only be the manufacturer or its official representative.
The 2C product
certification scheme differs from the 1C scheme in that instead of the
production audit, the applicant must provide a quality management certificate.
In addition, both products and production will be subject to periodic
inspections.
3C and 4C
These schemes are
selected for a single batch of products (3C) or for the goods in a single copy
(4). These product certification schemes for the requirements of TS CU provide
for quality assurance only on the basis of a sample examination protocol
conducted in an accredited laboratory.
The applicant may
be a seller or supplier registered both within the Customs Union and beyond.
5С
Elected for
mass-produced goods. But unlike the 1C and 2C schemes, the main focus is not on
the examination of finished products, but on production control and examination
of project documentation. This certification scheme is applied for products
whose quality cannot be fully confirmed by the examination of finished samples.
For 5C, the following
quality assurance measures are relevant:
- examination of
project and technical documentation;
- examination of
production capacity;
- periodic quality
control of either products or production.
The applicant can
be a manufacturer or its representative registered on the territory of the
vehicle.
Scheme 6C is
almost identical to scheme 5C, except for the fact that periodic monitoring is
carried out both in terms of production and in respect of finished products. In
addition, the expertise of the production was replaced by the mandatory
procedure of certification of the quality management system.
7С
This certification
scheme TR TS designed for large-scale production. In addition, we are talking
about a technically complex product with a large number of modifications, which
may consist of many independent components. The peculiarity of the 7C and 8C
schemes is that the samples are received for examination as a type or a basic
product, and not a finished product.
The following
confirmation forms are relevant for the 7C product certification scheme:
- examination of
samples;
- revision of
production capacity;
- periodic
inspection of samples or analysis of production.
Only a
manufacturer or its official representative registered on the territory of the
Customs Union can apply for a certificate under the 7C scheme.
8C is identical to
the 7C scheme. The differences lie in the fact that the primary control of
production is carried out in the form of certification of quality management,
and both production and samples of products are subject to current control.
9C
This product
certification scheme is used to confirm the quality of imported goods supplied
in small batches for a limited period of time. The main category of products
that are certified in 9C - industrial equipment or high-tech components for the
production located on the territory of the vehicle. In view of the fact that
this product, as a rule, is a non-independent element of a complex structure,
it is not certified as a finished product. Accordingly, neither the expertise
of the production, nor the current control is carried out, and the compliance
with the safety requirements is checked solely by studying technical data.
联系我们:上海经合工业设备检测有限公司/俄罗斯EAC证机构中国代表处
电话:021-36411223 36411293
邮件:eac@cu-tr.org
手机微信:18621862553
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