Scheme number
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Tests in accredited test centers
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Assessment of production state (quality system)
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Inspection control of the certified products (quality system, production state
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1
|
Type tests*
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-
|
-
|
1a
|
Type tests
|
Analysis of production conditions
|
-
|
2
|
Type tests
|
-
|
Tests of seller's samples.
|
2a
|
Type tests
|
Analysis of production conditions
|
Tests of seller's samples. Analysis of production conditions.
|
3
|
Type tests
|
-
|
Tests of manufacturer's samples.
|
3a
|
Type tests
|
Analysis of production conditions
|
Tests of manufacturer's samples. Analysis of production conditions.
|
4
|
Type tests
|
-
|
Tests of seller's samples. Tests of manufacturer's samples.
|
4a
|
Type tests
|
Analysis of production conditions
|
Tests of seller's samples. Tests of manufacturer's samples. Analysis of production conditions.
|
5
|
Type tests
|
Certification of production conditions or quality system.
|
Control of certified quality system (production conditions). Tests of seller's and (or) manufacturer's samples.**
|
6
|
Declaration review to identify correspondence with attached documents.
|
Certification of quality system
|
Control of certified quality system.
|
7
|
Tests of product batch.
|
-
|
-
|
8
|
Tests of each sample.
|
-
|
-
|
9
|
Declaration review to identify correspondence with attached documents.
|
-
|
-
|
9a
|
Declaration review to identify correspondence with attached documents.
|
Analysis of production conditions.
|
-
|
10
|
Declaration review to identify correspondence with attached documents.
|
-
|
Tests of seller's and (or) manufacturer's samples.
|
10a
|
Declaration review to identify correspondence with attached documents.
|
Analysis of production conditions.
|
Tests of seller's and (or) manufacturer's samples. Analysis of production conditions.
|
* - Tests of manufactured products based on the assessment of one or several typical representative samples.
** - Necessity and volume of the tests, as well as the place of sampling is determined by the certification authority based on inspection results of the certified quality system (production conditions).
Notes. 1. Schemes 1 - 8 are approved in the foreign and international classification ISO. Schemes 1а, 2а, 3а and 4а are complementary modifications of schemes 1, 2, 3 and 4, respectively.
Schemes 9 - 10а are used based on the supplier's accordance declaration, which is recognized in the EU as a proof of product correspondence to the established requirements.
Inspection control according to the Table above is applicable after the certificate has been issued.
Application of certification schemes
Certification schemes 1 - 6 and 9а - 10а are applicable for certification of batch products manufactured during effective term of the certificate; Schemes 7, 8, 9 are used for certification of the earlier manufactured batch of products or single product.
Schemes 1 - 4 are recommended in the following cases:
- Scheme 1 - for limited and earlier agreed volume of products, which is supposed to be delivered (distributed) for a short time in separate batches (for imported products - under short-term contracts; for domestic products - limited manufacturing output).
- Scheme 2 - for imported products under long-term delivery contracts or stable deliveries of batch products under separate contracts with compulsory inspection control of the samples taken in the Russian Federation from imported batches.
- Scheme 3 - for the products manufactured in batches on a stable basis.
- Scheme 4 - if all-round and strict inspection control of batch products is necessary.
Schemes 5 and 6 are recommended for product certification in the following cases:
- Actual number of test samples is not sufficient for unbiased assessment of the manufactured products.
- Technological processes are sensitive to external factors.
- Rigid requirements are established for stability of the manufactured product characteristics.
- The effective time of product is shorter than that of organization and testing in the accredited test laboratory.
- Frequent change of the product modifications.
- The product can be tested after installation at the user's site.
Scheme 6 is used on availability of the manufacturer's testing system, which identifies correspondence between the characteristics and requirements applicable in the certification of such products as proved by the attached abstract from the inspection and quality system assessment report.
Scheme 6 can be also used for certification of the supplier's (but not manufacturer's) imported products, if he submits a certificate for his quality system and if nomenclature of the certified characteristics and their values correspond to regulation requirements applicable in the Russian Federation.
Schemes 7 and 8 are recommended for certification of the products manufactured or distributed on a single basis (batch, single item).
Schemes 9 - 10а are used if a declaration of accordance, together with attached documents, proves product correspondence (non-correspondence) to the established requirements.
Declaration of accordance contains a statement of the authorized manufacturer's (seller's) representative, who takes responsibility to confirm that his products correspond to the established requirements.
A fully executed (signed and stamped by the head of the manufacturing or selling company) declaration of accordance is submitted to the certification authority together with the attached documents and covering letter.
A certification authority reviews the submitted documents and, if necessary, requests for additional information (users'claims, results of technological process control, documents issued by the executive authority to prove product correspondence to the established requirements, etc.). Simultaneously a certification authority compares the product sample with the attached documents.
If comparison results are positive, a certification authority grants an accordance certificate to the manufacturer.
Certification schemes 9 - 10а are applicable if a declarant has all the documents to prove, directly or indirectly, the accordance of the products to the declared requirements. If this condition is not satisfied, a certification authority recommends the declarant different certification schemes for declared products, which take into account single proofs of accordance contained in the attached documents.
These schemes are reasonable for certification of the products manufactured by foreign or Russian small businesses or in single small batches.
Schemes 9 - 10а are advisable in the following cases:
- Scheme 9 - for certification of single small-size batch of imported high-quality products manufactured by the company renowned world-wide or in Russia, or for single items, single kit of products specifically intended for equipment of the Russian production or any other facilities, if submitted technical documentation gives a sufficient proof of product safety.
- Scheme 9а is applicable for certification of domestic products, including the goods produced by properly registered individual businesses, if inspection control is not reasonable, and manufacturing process is not regular and depends on the market demand.
- Schemes 10 and 10а are advisable for long-term, but small-size production of domestic goods.
Schemes 1а, 2а, 3а, 4а, 9а and 10а are recommended instead of corresponding schemes 1, 2, 3, 4, 9 and 10, if certification authority lacks any proofs of reproducibility of stable characteristics proved by the tests for a definite type of products.
It is a required prerequisite for Schemes 1а, 2а, 3а, 4а, 9а and 10а that quality system (production) experts are involved in the analysis of production conditions, or product certification experts after they have had special training, which includes production assessment problems.
Compulsory certification according to these schemes does not require the analysis of production conditions on availability of manufacturer's accordance certificate for production or quality system.
Compulsory certification according to Schemes 5 or 6 does not require a repeated procedure of production or quality system certification on availability of manufacturer's accordance certificate for production or quality system earlier issued in accordance with the same or more extended certification model.
Described certification schemes are established in the certification systems (rules) of the same product type taking into account the product specificity, manufacturing conditions, product handling and application.
A concrete certification scheme of the given goods is determined by the certification authority.