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CERTIFICATION CENTER
ENERGIA PLUS

Our address: 141075, Moscow region,
Korolev, ul. Sosnovaya Alleya, 6
Tel./fax: (495) 502-888-2,
(495) 502-888-9.
E-mail: 1011455@mail.ru
ICQ: 355-244-011

Certification of Products and Quality Management Systems


CERTIFICATION OF PRODUCTS


ATTENTION!!! Manufacturers of prosthetic-orthopedic products: there were changes in the list of compulsory certification. ORDER # 3589 of December 18, 2007.

   Products for medical use are certified according to the certification rules for the electrical appliances and electricity.
   You can read about certification schemes and deadlines in the Certification Rules.

LIST OF PRODUCTS WHICH REQUIRE CERTIFICATION AND HAVE TO BE DECLARED ACCORDING TO THE LEGISLATION OF THE RUSSIAN FEDERATION   (as a .rar archive 200 Kb, compulsory certification is marked in yellow, compulsory declaration is marked in magenta color)  

List of documents necessary for the certification of the imported goods:

1. Order: download an order for certification
2. Designation of authority from the manufacturer for conducing the certification and payment for the certification activities or a contract for the delivery of goods which clearly specifies a number of items (invoice)
3. A copy of the registration certificate (submitted once)

4. A copy of the Charter (submitted once)

5. Trial protocols (if available)
    5.1. An order for toxicology testing

6. Marked product samples

7. Registration certificate issued by the Federal Service for the Healthcare and Social Development (Roszdravnadzor) (for the medical products)

The format of all the document copies should comply with the GOST R 6.30-2003 article. 3.26

List of documents necessary for the certification of the Russian goods:

2. A copy of the registration certificate (submitted once)

3. A copy of the Charter (submitted once)

4. A copy of the technical specification

5. Trial protocols (if available)
    6.1. An order for toxicology testing

6. Marked product samples

7. Registration certificate issued by the Federal Service for the Healthcare and Social Development (Roszdravnadzor) (for the medical products)

The format of all the document copies should comply with the GOST R 6.30-2003 article. 3.26

CERTIFICATION OF THE QUALITY MANAGEMENT SYSTEM


List of documents necessary for the certification of the quality management system:

1. An order for certification of the quality management system
2. An inner audit report of the enterprise quality management system
3. A certificate of the product quality
4. Quality guidelines, authorized by the Head of the enterprise
5. If the quality guidelines do not describe the compulsory procedures, then six compulsory documented procedures, specified by the GOST R ISO 9001-2001 requirements (articles 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, 8.5.3) should be submitted.
6. Organizational structure of the enterprise quality management system

     If You run into any difficulties compiling the documents, feel free to contact us and we will be happy to help You prepare all the documentation.

Here you can check our accreditation scope (783Kb) or as an archive (71Kb).

Here you can also obtain an order form, fill it in and forward it to our address.



Head: Shandova Nadezhda Pavlovna
tel./fax: (495) 502-88-81, 502-88-82, 502-888-9
cell phone.: (495) 101-14-55
E-mail: 1011455@mail.ru  ICQ 355-244-011
Address: ul. Sosnovaya alleya, 6, Korolev, Moscow region, 141075
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