Certification ISO

Certification in Russia

Certification in Russia started in 1993 according to the Law of the Russian Federation “About protection of the rights of consumers” establishing the necessity of certification of consumer goods safety.

During the next 10 years the legislative basis for confirmation of conformity of different kinds of production has been forming, and in December, 2002 for the purpose of the introduction of Russia in the World Trade Organization (WTO) the Federal Law “About technical regulation” (further the Law) was adopted thus cancelling operation of the laws “About certification of production and services” and “About standardization”. The Law is that the principle of obligatory engineering standards compliance should be replaced by a principle of standards compliance on a voluntary basis.

According to the Law, the Certification is an obligatory or voluntary acknowledgement of that the goods or all system of organization of work correspond to certain standards. The inventory, production and services subjected to obligatory certification are presented in the Governmental Decision of the Russian Federation of August, 13,1997 № 1013 and the Decision of Gosstandart of the Russian Federation of July, 30, 2002 № 64. If the goods or rendered service do not require obligatory certification the manufacturer can voluntary confirm its quality by receiving a corresponding certificate.

Why voluntary certification is necessary

ISO 9000 certified systems of quality management are not necessary. However voluntary certification of the enterprise for compliance with ISO 9000 international standards is essential for creation of favorable conditions in activity of enterprises, organizations and businessmen in the market of goods and services in the Russian Federation territory, as well as possibility to participate in the international economic, scientific and technical cooperation and international trade with weighty proof of a solvency and competitiveness of organization. The urgency of ISO certification is caused by that consumers take into count not a cost of goods or service, but their quality. The order of voluntary certification is practically identical to obligatory one, but at the given kind of certification the organization has the right to define the parameters (standards) of its production independently.

How to receive the certificate

There are three ways to certify systems of quality management.

  • The First is according to ISO 9000—2000 international standards when the certificate is issued by sertifying company accredited by authorized foreign structure.
  • The Second is according to State Standard GOST Р when the conformity certificate is issued by sertifying company accredited at Federal agency on technical regulation and metrology (Rostekhregulirovanie).
  • The Third is on the basis of ISO 9000:2000 standards and corresponding GOST Р by private companies or self-regulated associations of firms.

Bodies on certification in the System carry out following functions:

  • certify production, works and services, systems of management (manufactures) and experts of system;
  • issue conformity certificates;
  • carry out the inspection control of their certificated objects;
  • authorize the applicant to apply a mark of conformity;
  • stop or cancel the action of the issued certificates of conformity;
  • participate in working out of organizational-methodical documents of the System.

Certification stages of quality system

In the course of certification of quality system two stages are distinguished:

  • preliminary check and estimation of quality system;
  • final check, estimation and issue of certificate of conformity of quality system for the enterprise of the corresponding standard.

Certificate preparation term is 2 weeks, working out of normative and technical documentation (NTD) is 1—2 months.

Documents for preparation of the certificate of conformity according to ISO 9000 and all its versions:

  • Constituent documents — copies;
  • Copies of acting licenses with a list of legal kinds of activity;
  • Positive characteristics of organization (responses, certificates, diplomas of exhibitions...);
  • List of completed objects, production (with short description) or rendered services at the moment;
  • List of normative and technical documentation (GOST, specifications, SNiP) according to which the organization works and produces the goods;
  • Quality document (quality manual, policy concerning quality, and etc.);
  • Organization structure (including production units);
  • List of production units with indication of the basic functional duties;
  • Qualifying structure of the organization (engineers, education, work experience, specialty...) specifying a person responsible for quality from administration and the chief of service of quality;
  • Demand for certification.

The certificate is issued for a period of 3 years with the following prolongation. During term of validity of the certificate of conformity the body on certification annually carries out the inspection control to prove the conformity of the given System to standard requirements.

Certificates are valid everywhere in the Russian Federation.

History of ISO occurrence

The family of ISO 9000 standards started its history in 1987, when the International Organization for Standardization (International Organization for Standardization or ISO) has upheld the first version of universal standards for certification of quality systems: ISO 9000:87. When working out ISO 9000 standards, the standards used by the USA Ministry of Defense for an estimation of systems quality assurance for suppliers of defense production were assumed as a basis.

The next version of standards of ISO 9000 series appeared in 1994. Basically it repeated the structure of 1987 standards with elimination and decoding of obscure points.

The new version of the international standards of ISO 9000 (ISO 9000:2000) series of December, 15, 2000 has officially replaced the previous version of standards of 1994. Resulting from revision the new ISO 9001:2000 standard has a number of basic differences. So, for example, the complex of documents earlier consisting of 24 standards, now includes 5 basic standards:

  1. ISO 9000:2000 System of quality management. Main principles and a dictionary.
  2. ISO 9001:2000 System of quality management. Requirements.
  3. ISO 9004:2000 System of quality management. Guidelines on improvement.
  4. ISO 19011:2000 Guidelines on check of system of quality management and environment protection.
  5. ISO 10012 Providing of measuring equipment quality.

In our country the existing ISO 9000 certificate from August, 15, 2001 is represented by GOST Р ISO 9000 (9001) — 2001 recognized by Russian and a number of foreign companies. It includes the certification substantive provisions, and also the dictionary of terms.

  1. GOST Р ISO 9000—2001 describes the main provisions of the systems of quality management and establishes terminology for systems of quality management;
  2. GOST Р ISO 9001—2001 defines the requirements to systems of quality management for the cases when the organization has to show its ability to produce goods meeting the requirements of consumers and obligatory requirements, and is directed on satisfaction of consumer needs;
  3. GOST Р ISO 9004—2001 contains the recommendations considering both productivity and effectiveness of the system of quality management. The purpose of this standard is an improvement of activity of the organization and satisfaction of consumer needs and other parties concerned;
  4. GOST Р ISO 19011 contains methodical instructions on audit (check) of systems of quality management and environment protection.
  5. Standards of ISO 9000 series are applicable for the organizations of any kind of activity, regardless of branch of industry or economy sector.