| 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 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 |
