Foreword

Objectives and principles of standardization in Russian Federation established by the Federal Law of December 27, 2002 No. No. 184-FZ"On technical regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004“Standardization in the Russian Federation. Basic provisions "

Information about the standard

1 DESIGNED Open joint stock company"All-Russian Scientific Research Institute of Certification" (JSC "VNIIS")

2 INTRODUCED by the Technical Committee "Quality Management and Conformity Assessment" (TC 079)

3 APPROVED AND PUT INTO EFFECT by Order of the Federal Agency for Technical Regulation and Metrology No. 615-st dated November 30, 2010

4 INTRODUCED FOR THE FIRST TIME

5 This standard implements the norms Federal law"On technical regulation" (Articles 2, 25, 26, 28, 34)

Information on changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments- v monthly published information indexes "National Standards". In case of revision (replacement) or cancellation of this standard, the corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notice and texts are also posted in information system general use - on the official website of the national body of the Russian Federation for standardization on the Internet

Introduction

National Standard of the Russian Federation “Conformity Assessment. Inspection control of certified products "is included in the System of Conformity Assessment Standards, which is similar in purpose and principles the international system ISO / IEC series standards 17000.

Under the conformity assessment in the international standard ISO / IEC 17000: 2004 “Conformity assessment. Dictionary and general principles»Means evidence that specified requirements for a product, process, system, person or body are met.

National standards included in the System of Conformity Assessment Standards are harmonized with the relevant international standards ISO / IEC 17000 series to the extent that their effective application in the territory of the Russian Federation is possible.

This national standard has been developed taking into account the provisions Federal law"On technical regulation", the Procedure for conducting certification in the Russian Federation, Recommendations for the inspection control of certified products R 50-601-43-94, ISO / IEC Guide 67: 2004 "Conformity assessment - Basics of product certification", ISO / IEC Guide 28 : 2004 "Conformity Assessment - Guidelines for a Third Party Product Certification System".

This national standard develops the provisions of the national standard GOST R 53603-2009“Conformity assessment. Product certification schemes in the Russian Federation "in terms of the element of the certification scheme - inspection control.

It aims to create general approach to the procedures of inspection control over certified products, contributing to the achievement of constant compliance of the manufactured products with the requirements, confirmed by the certificate of conformity.

The standard can be used in mandatory and voluntary certification.

NATIONAL NEW STANDARD OF THE RUSSIAN FEDERATION

Conformity assessment

INSPECTION CONTROL OF CERTIFIED PRODUCTS

Conformity assessment. Certified products surveillance

Date of introduction - 2012-01-01

1 area of ​​use

This International Standard establishes the rules for conducting inspection control of certified products and making decisions based on its results.

The standard applies to mandatory and voluntary certification.

The standard is intended for developers of technical regulations, developers of voluntary certification systems and for use in the practice of certification bodies, testing laboratories (centers) and applicants.

2 Normative references

This standard uses normative references to the following standards:

5.5 The scope of the inspection check by the decision of the certification body can be established within the scope of the previous checks (during certification, during the previous inspection check) or can be adjusted taking into account the following factors:

The stability of the characteristics and the margin of their values ​​in relation to the maximum permissible ones revealed in previous checks;

The laboriousness of determining each product characteristic;

The results of an earlier audit of the functioning of the quality system or analysis of the state of production;

Results state control(supervision) of products covered by the certificate of conformity;

The results of the production tests of products carried out by the applicant (acceptance, periodic, typical);

Data received from the applicant about claims for defects identified by the purchasers of the products.

5.6 Unscheduled inspections are carried out by the decision of the certification body in cases of receipt of information about a violation or the possibility of violations of the requirements for manufactured products, which necessitate an inspection before the scheduled date for the next inspection.

5.6.1 The basis for making a decision to conduct an unscheduled inspection can be information about claims to the quality and safety of products from consumers, trade organizations, from the media, as well as bodies and organizations exercising public or state control over the products for which the certificate is issued. compliance, including the information received by the certification body from the state control (supervision) authorities on the violations identified and the need to suspend or terminate the validity of the certificate of conformity.

Unscheduled inspections can also be carried out upon receipt of information from the holder of the certificate of conformity about the changes made to the technical documentation and technological process production of certified products.

5.6.2 The certification body analyzes the information received. Based on the results of the analysis, he can make decisions in accordance with the section or assign an additional check in accordance with the section of this standard.

5.7 The scope of an unscheduled inspection is determined based on the information received and the nature of the violations of the established requirements noted in it.

6 Preparation and performance of work on inspection control

6.1 Inspection control consists of the following stages:

Collection and analysis of information on certified products;

Development and approval of the inspection program;

Formation of an inspection team;

Inspection check;

Registration of the results of the inspection;

Decision-making based on the results of inspection control.

6.2 Collection, systematization and analysis of information on certified products is carried out by the certification body constantly during the validity period of the certificate in order to obtain additional information for inspection or direct decision-making.

Sources of information about certified products are:

Information provided by the certificate holder about the changes made to the technical documentation and the technological process for the production of certified products;

Information from the bodies of state control (supervision), messages in the press, on radio and television, on the Internet.

The information received and the results of their analysis are reflected in reports, certificates and other documents. Forms of documents and the procedure for their preparation are recommended to be established in the quality manual of the certification body.

6.3 The inspection program is developed by the certification body. The program, depending on the certification scheme, must contain (in addition to general information about the enterprise, certified products, the timing of the inspection) inspection tasks, including:

Product identification;

Tests;

Checking the status of production or monitoring the quality (production) system;

Verification of the application of the mark of circulation on the market or the mark of conformity;

Verification of purchaser complaints about the products received;

Registration of test results.

6.3.1 Specific tasks are formed on the basis of operations carried out during product certification, taking into account information obtained from the results of certification or previous verification.

In the event that certification deficiencies are identified that are included in the corrective action plan, but have not been verified in the certification process, the inspection program provides for monitoring the implementation of such corrective actions.

6.3.2 Tasks for testing include the establishment of the verified parameters of the product, information about the selection of samples (samples) and the place of testing, the possibility of offsetting the results of tests carried out by the manufacturer or other organizations.

6.3.3 Tasks for checking the state of production include the objects of check: technical documentation, technological processes, the state of technological equipment, a system of control and testing, metrological support.

6.3.4 Tasks for quality system control are formed based on the requirements GOST R ISO 9001 and GOST R ISO 19011.

6.3.5 Tasks for the analysis of the state of production or control of the quality system can be formalized in the form of independent programs.

6.3.6 The inspection program, approved by the head of the certification body, is communicated in advance to the applicant and other participants in the inspection.

6.4 Product identification is carried out by checking the current regulatory and technical documentation on products for the absence of significant changes in them that affect the preservation of the type in relation to the samples that have passed certification tests, as well as checking the nature of changes made to the regulatory documents for which the products were certified. In addition, the selected product samples are compared for homogeneity, the marking is checked, including the conformity mark (mark of circulation on the market).

6.5 Sampling is carried out according to the method used for certification, depending on the certification scheme at the manufacturer and (or) in trade organizations (wholesale bases). The selection is carried out by the inspection team or on behalf of the certification body by the testing laboratory. The selection of samples is formalized by the act of sampling.

Selected and sealed samples are sent to an accredited testing laboratory. The organization of delivery of samples to the test site, the scope and conditions of testing are agreed with the testing laboratory and the certificate holder. With a considerable remoteness of the testing laboratory and the presence of a proper testing base at the inspection site, by the decision of the certification body, inspection tests can be carried out on this base in the presence of a representative of the certification body or testing laboratory.

6.5.1 The results of the inspection tests carried out shall be recorded in a protocol. In justified cases, by decision of the certification body, instead of inspection tests, the results of previously conducted periodic or type tests may be used in full or in part, unless otherwise provided by the certification rules.

6.5.2 The results of inspection and other tests are recommended to be compared with the results of certification tests to identify trends in the characteristic values ​​during the verification period.

6.6 Verification of production (quality system) during certification is carried out:

When using the procedure for analyzing the state of production - a product certification body;

When using the quality system assessment procedure - a quality system certification body or a product certification body in the presence of an expert on quality systems certification;

When using the procedure for certification of a quality system or production, a certification body for quality systems that issued a certificate of conformity for this quality system or production.

6.7 Inspection of production (quality system) and registration of its results is carried out in accordance with programs and methods developed by certification bodies that carry out inspection control over certified products.

In all cases, the analysis of claims and complaints of consumers, as well as an analysis of the shortcomings identified by the state control (supervision) bodies, is provided.

6.8 Verification of compliance with the conditions for the use of the mark of conformity (mark of circulation on the market) should begin with checking the presence and correctness of the application of this mark on products (containers, packaging, accompanying and technical documentation). The check is carried out at the manufacturer and (or) in trade organizations if provided for by the surveillance program.

The results of the inspection are drawn up in separate documents for each operation provided for by the certification scheme: test reports, an act based on the results of an analysis of the state of production, an act of quality control, etc.

The documents based on the results of the inspection must contain sufficient information and conclusions, allowing, on their basis, to make an unambiguous conclusion about the validity of the certificate of conformity. On the basis of these documents, an act is drawn up, which provides an assessment of the test results of samples, the stability of product quality and a general conclusion on the state of its production.

7 Adoption and execution of decisions based on the results of inspection control

7.1 The results of the inspection control are drawn up in an act, which gives an assessment of the results of testing samples and other checks, a conclusion is made about the possibility (impossibility) of maintaining the validity of the issued certificate. The form of the inspection control report is given in the appendix.

If deficiencies in the act are identified, they indicate the need to develop corrective measures to eliminate them.

The inspection control report is submitted for review to the head of the manufacturer (certificate holder). One copy of the act remains with the certificate holder. Another copy of the act is kept by the certification body

7.2 An inspection control report containing a positive assessment for all tasks of the inspection program means the decision of the certification body to confirm the validity of the certificate of conformity. In the event of a negative assessment, the certification body draws up a corresponding decision.

7.3 The certification body may decide to suspend or terminate the validity of the certificate of conformity in case of non-conformity of products to the established requirements, as well as in the following cases:

Changes regulatory document for products or test methods;

Changes in the design (composition) and completeness of products;

Changes in the organization and (or) production technology;

Changes (non-fulfillment) of technology requirements, methods of control and testing, quality system;

Refusal of the certificate holder to carry out or pay for the inspection control;

Lack of certificate holder necessary conditions to conduct an inspection in set time, according to .

The form of the decision to suspend the validity of the certificate of conformity is given in the appendix, the form of the decision to terminate the validity of the certificate of conformity is in the appendix.

7.4 The decision to suspend the validity of the certificate of conformity is taken if, by means of corrective measures agreed with the certification body, the certificate holder can eliminate the detected causes of non-conformity and confirm the conformity of the product to the established requirements. Otherwise, the certificate is terminated.

7.5 In case of suspension of the certificate of conformity, the certificate holder, together with the certification body, develops corrective measures to eliminate the identified deficiencies. The certification body sets the deadline for the implementation of corrective measures and checks their implementation.

7.6 In case of positive results of verification, the validity of the certificate of conformity is restored, in case of negative results, the certification body decides to terminate the validity of the certificate of conformity. The form of the decision to renew the validity of the certificate of conformity is given in the appendix.

7.7 Information on the suspension or termination of the certificate of conformity in accordance with the current procedure is brought by the certification body to the attention of the certificate holder, territorial bodies of state control and supervision at the location of the manufacturer (seller), customs authorities(for imported products) to take appropriate action.

Inspection control report form

ACT No. inspection control of certified products "__" __________ 200_ Certification body ____________________________________________________ Name in the period from _____________ 200_ to ______________ 200_ conducted an inspection in accordance with the approved program product control, product name and designation manufactured by ______________________________________________________________ Manufacturer's name on _________________________________________________________________________ Name and designation of the regulatory document certified for compliance with ___________________________________________ The name and designation of the regulatory document (technical ___________________________________________________________________________ regulations) When checked, it was found: _____________ 1 Column 1 indicates the sections of the program containing tasks. 2 Column 2 gives conclusions on specific tasks of the corresponding section of the program. ___________________________________________________________________________ ___________________________________________________________________________ Conclusion ________________________________________________________________ General assessment of the conformity of products to the established requirements, ___________________________________________________________________________ the state of its production, the possibility (impossibility) of maintaining the validity of the certificate of conformity ___________________________________________________________________________ Applications: _______________________________________________________________ Test reports, ___________________________________________________________________________ conclusions on the state of production, etc. Head of the certification body ________________ _____________________ Signature initials, surname Product Certification Expert ______________ _______________________ Signature initials, surname Acquainted with the act Manufacturer's manager (certificate holder) _________________ ________________________ Signature initials, surname

Form of decision to suspend the validity of the certificate of conformity ___________________________________________________________________ name and registration number of the certification body SOLUTION NO. from ___________________________ on the suspension of the certificate of conformity Based on the reviewed documents: ___________________________________________________________________________ ___________________________________________________________________________ suspend the certificate of conformity ______________________________, No., date of issue ___________________________________________________________________________ or full name of an individual entrepreneur from ______________________ to ____________________ For the holder of the certificate of conformity to carry out corrective actions by ________________________________ name and details of documents ___________________________________________________________________________ terminate the certificate of conformity __________________________________, No., date of issue issued by _________________________________________________________________ Applicant's organization name ___________________________________________________________________________ With ______________________ Notify the present decision ___________________________________________________________________________ names of organizations M.P. Head of the body By certification ________________________ _________________________ Signature initials, surname

Form of decision to renew the validity of the certificate of conformity __________________________________________________________________ name and registration number of the certification body SOLUTION NO. from ______________________________ on renewal of the certificate of conformity In connection with the fulfillment by the certificate holder of corrective measures to eliminate the non-conformity of products with the established requirements, renew the validity of the certificate of conformity No. _________________________ from ________________. No., date of issue issued by _________________________________________________________________ Applicant's organization name ___________________________________________________________________________ or full name individual entrepreneur which was suspended by Decision No. ______________________ 09/21/1994, No. 15 and registered by the Ministry of Justice of Russia on 04/05/1995, No. 826 (with amendments and additions) Keywords: confirmation of conformity, certification scheme, inspection control, testing, analysis of the state of production, certification body, applicant, certificate of conformity, mark of circulation on the market, mark of conformity

Inspection control of certified products is carried out during the entire period of validity of the certificate and license to use the conformity mark - at least once a year in the form of periodic and unscheduled inspections, including tests of product samples and other checks necessary to confirm that the products sold continue to comply with the established requirements confirmed during certification.

Unscheduled inspections can be carried out in cases of receipt of information about claims to the quality of products from consumers, trade organizations, as well as bodies exercising public or state control over products for which a certificate has been issued.

Inspection control, as a rule, contains the following types of work:

- analysis of incoming information about certified products;

- creation of a commission to conduct control;

- conducting tests and analyzing their results;

- registration of control results and decision making.

The results of the inspection control are drawn up in an act, which gives an assessment of the results of testing samples and other checks, a conclusion is made on the state of production of certified products and the possibility of maintaining the validity of the issued certificate.

Based on the results of the inspection control, the certification body can suspend or cancel the validity of the certificate (in this case, it suspends or revokes the license to use the conformity mark) in case of non-compliance of the product with the requirements of regulatory documents controlled during certification, as well as in the following cases:

- changes in the normative document for the product or the test method;

- changes in the design (composition), completeness of products;

- changes (non-fulfillment) of technology requirements, methods of control and testing, quality assurance system, if the listed changes can cause non-conformity of products to the requirements controlled during certification.

When carrying out corrective actions, the certification body:

- suspends the validity of the certificate and the validity of the license for the use of the conformity mark;

- informs interested participants of certification;

- sets the deadline for the implementation of corrective actions.

Manufacturer (seller):

- determines the scale of the identified violations: the number of products produced in violation, model, number and size of the batch;

- notifies consumers, the public, interested organizations about the dangers of using (operating) products.

After corrective actions have been taken and the results are satisfactory, the certification body:

- indicates to the manufacturer (seller) the need for a new marking to distinguish the product before and after corrective measures, while in each case it determines the nature and type of marking;

- informs interested participants of certification.

If the manufacturer (seller) fails to comply with the corrective measures and their ineffectiveness, the certification body cancels the certificate and revokes the license to use the conformity mark.

1 AREA OF USE

This document contains recommendations for organizing, conducting inspection control of certified products and making decisions on its results. The recommendations have been developed in relation to the GOST Certification System. The provisions of the document can be used in other certification systems, taking into account their peculiarities.

2. LINKS

This document has been developed taking into account the following documents: "Rules for certification in the Russian Federation" "GOST R certification system. Procedure for certification of products." The provisions of this document comply with the Laws of the Russian Federation "On Protection of Consumer Rights" and "On Certification of Products and Services".

3. DEFINITIONS

The terms and definitions used in the document correspond to the document "Rules for certification in the Russian Federation" and GOST 16504 "Testing and product quality control. Basic terms and definitions". The document also uses the term: Certificate holder - an enterprise, organization, institution or citizen-entrepreneur, in whose name the certificate of conformity was issued.

4. GENERAL PROVISIONS

4.1. Inspection control of certified products is carried out in order to establish that the manufactured products continue to meet the requirements for which they were certified, and the certificate holder fulfills the terms of the license * for the use of the conformity mark. The need for and the procedure for conducting inspection control is determined by the certification scheme adopted for this product. 4.2. Inspection control over certified products is carried out by the body that issued the certificate of conformity, inviting, if necessary, the territorial bodies of the Gosstandart of Russia, others government bodies management, public organizations or individual specialists. 4.3. When planning work on inspection control in order to avoid duplication, it is advisable to link the timing of their implementation with the work carried out by the bodies of state control and supervision over the compliance of products with mandatory requirements of standards. 4.4. The basis for the inspection control is the certification agreement ( supplementary agreement to him). If the stage of the inspection control is not specified in the certification contract, then a separate contract for the inspection control is concluded. The contracts establish the types of work, the timing and payment terms for the inspection control. Participation in the inspection control of third-party organizations is carried out on the basis of agreements between the certification body and these organizations or directly by their specialists. 4.5. Inspection control is carried out during the entire validity period of the certificate of conformity in the form of a systematic analysis of information on certified products and inspection checks. 4.6. The result of the inspection control serves as the basis for the certification body to make appropriate decisions on the possibility of maintaining (suspending or canceling the validity) of the issued certificate of conformity and license, for the application of the conformity mark. 4.7. Appeals in case of disagreement with the results of inspection control, the certificate holder can submit to the appeal commission of the certification body, the central body of the relevant certification system for homogeneous products or the Gosstandart of Russia. 4.8. The work on inspection control is paid by the holder of the certificate. * In case of voluntary certification - conditions of the contract

5. TYPES, TERMS AND SCOPE OF INSPECTION CHECKS

5.1. During inspection control, periodic and, if necessary, unscheduled inspections are carried out. 5.2. The frequency of inspections should be sufficient to provide confidence that during the inter-inspection period the products will continue to meet the requirements for which they have been certified. 5.3. Frequency of inspections and organizational forms they are recommended to be established taking into account the following criteria: - the specificity of the product and the degree of its potential hazard; - volume and duration of production; - the presence of a quality system at the manufacturer, including confirmed by a certificate of conformity, or the presence of a production certificate; - production stability; - reputation of the manufacturer in relation to the quality of the products; - the cost of conducting an inspection. 5.4. The frequency of inspection checks is established during product certification, based on the conditions specified in clause 5.3. and taking into account the recommendations of the commission that certified the products, but at least once a year. 5.5. The scope of the inspection is established on the basis of the certification scheme and the range of certified characteristics, taking into account the following criteria: - the complexity of determining each characteristic; - the stability of each characteristic and the margin of their values ​​in relation to the established ones; - the results of previous inspections, including inspections carried out by state control and supervision authorities, as well as other information about certified products; - test results (periodic, typical, etc.) carried out during the inter-verification period. 5.6. An unscheduled inspection check is carried out upon detection of significant violations of the requirements for certified products and the use of a conformity mark, which necessitate an operational decision by the certification body before the next check. 5.7. The basis for an unscheduled inspection may be information that directly or indirectly testifies to violations by the certificate holder (complaints, claims and reclamations of consumers, products :, trade, consumer societies, decisions taken by bodies of state control and supervision), information on changes, included in the regulatory documentation, design, (composition), technology of its production, which may affect the certified characteristics. 5.8. The decision on the need for a specific unscheduled inspection is made by the certification body based on an analysis of the information currently available. 5.9. The scope of an unscheduled inspection is determined based on the need to verify the information received and the nature of the noted violations of the requirements.

6. ORGANIZATION AND CONDUCT OF WORKS ON INSPECTION CONTROL

6.1. Inspection control consists of the following stages: - collection and analysis of information on certified products; - development and approval of the inspection program; - formation of the inspection team; - conducting an inspection check; - registration of the results of the inspection; - making a decision based on the results of inspection control. 6.2. Collection, systematization and analysis of information on certified products is carried out by the certification body constantly during the validity period of the certificate in order to obtain additional information for inspection or direct decision-making. Sources of information about certified products are: - information provided by the owner of the certificate on changes made to the technical documentation and the technological process of manufacturing certified products; - information from the territorial bodies of the Gosstandart of Russia, other state control and supervision bodies, the central body for product certification, appeal commissions, consumer associations; - messages in the press, radio and television. The information received and the results of their analysis are reflected in reports, certificates and other documents. Forms of documents and the procedure for their preparation are recommended to be established in the quality manual of the certification body. 6.3. The inspection program is developed and approved by the certification body. It is recommended that the inspection program be drawn up simultaneously with the inspection control contract. The program should be flexible, allow for a change in the priority of the checked elements. Before the next inspection, the program can be updated taking into account the available information. The order of construction and presentation of the program is given in Appendix A. 6.4. The inspection is carried out by the certification body or, on its behalf, by another organization. The body (organization) carrying out the inspection forms an inspection team and appoints its leader. The group includes experts of the GOST R Certification System (or candidates who have undergone training in the prescribed manner), as well as representatives of the organizations specified in clause 4.2. In justified cases, by decision of the certification body, the inspection can be carried out by one expert. 6.5. The program and the timing of the audit are communicated in advance to all of its participants. The head of the inspection team acquaints the participants of the inspection with the results of the analysis of information about the certified products, distributes the work between them and decides with the management of the manufacturer (certificate holder) organizational issues related to the inspection (allocation of premises, necessary specialists , submission of documents, date and place of testing, etc.). 6.6. In the course of an inspection check, in the general case, the following is carried out: - sampling for identification and testing; - product identification; - tests; - production check; - verification of compliance with the terms of the license to use the conformity mark. 6.7. The selection of samples is carried out according to the methodology used for certification, depending on the certification scheme at the manufacturer and (or) in trade organizations (wholesale bases). The selection is carried out by an inspection team or on behalf of a certification body by a territorial body of Gosstandart of Russia or a testing laboratory. Sampling is drawn up in an act in the form of Appendix B. 6.8. Product identification is carried out by checking the current regulatory and technical documentation for products for the absence of significant changes in it that affect the retention of the type in relation to the samples that have passed certification tests, as well as checking the nature of changes made to the regulatory documents for which the products were certified. In addition, the selected product samples are compared for homogeneity, the marking is checked, including the conformity mark. 6.9. Selected and sealed samples are sent, as a rule, to an accredited testing laboratory. Organization of delivery of samples to the test site, the scope and conditions of testing are agreed with the testing laboratory and the holder of the certificate. With a considerable remoteness of the testing laboratory and the presence of a proper testing base at the inspection site, by the decision of the certification body, inspection tests can be carried out on this base in the presence of a representative of the certification body. The results of the inspection tests carried out are documented in a protocol. In justified cases, by decision of the certification body, instead of inspection tests, the results of previous periodic or type tests may be used in whole or in part. It is recommended that the results of inspection and other tests be compared with the results of certification tests to reveal the trend of changes in the values ​​of characteristics in the inter-verification period. 6.10. Production control is carried out by: - ​​product certification body (for certification schemes 2 a, 3 a, 4 a); - a certification body for quality systems (for certification schemes 5 and 6) with a certificate for the quality system; - a production certification body (for certification scheme 5) with a production certificate. According to certification schemes 2, 3 and 4, production inspection can be carried out by a product certification body in exceptional cases if there are reasons similar to those for an unscheduled inspection. Verification of quality systems (production) and registration of its results according to schemes 5 and 6 is carried out according to the methods developed by the certification bodies for quality systems (production), and according to schemes 2 a, 3 a, 4 a - according to the methods developed by the product certification body. In all cases, the analysis of claims and complaints of consumers, as well as deficiencies identified by the state, control and supervision authorities, is provided. Bodies for the certification of the quality system and production may entrust, in whole or in part, the performance of work on the verification of production to the body for certification of products. 6.11. Verification of compliance with the terms of the license to use the conformity mark should begin with checking the presence and correctness of the application of the conformity mark on products, containers, packaging, accompanying and technical documentation. Inspection is carried out at the manufacturer and in trade organizations, if provided for by the inspection program. Next, the presence of documents confirming the payment of license fees is checked. 6.12. At the end of the inspection, an act is drawn up, which gives an assessment of the test results of samples, the stability of product quality and a general conclusion on the state of its production. If deficiencies are identified in the act, they indicate the need to develop corrective measures to eliminate them. The form of the inspection report is given in Appendix B. 6.13. The inspection report, signed by all members of the inspection team, is submitted for review to the head of the manufacturer (certificate holder). One copy of the act remains with the holder of the certificate, and the rest - with the certification body.

7. MAKING DECISION ON THE RESULTS OF INSPECTION CONTROL

7.1. Based on the inspection report, taking into account the analysis of information on certified products, the certification body, depending on the results of inspection control, takes one of the following: following decisions: - consider the certificate of conformity and the license to use the mark of conformity as confirmed; - to suspend the validity of the certificate of conformity and (or) the license to use the mark of conformity; - to revoke the validity of the certificate of conformity and the license to use the conformity mark. The first decision is made in case of positive results of verification for all tasks of the program and (or) analysis of information on certified products in accordance with clause 6.2. The second or third decisions are made in case of negative results of the inspection check at least one task of the program. The decision to suspend the validity of the certificate of conformity is made when the identified deficiencies can be eliminated by means of corrective measures within the period established by the certification body. The decision to revoke the validity of the certificate of conformity is made in the following cases: - deficiencies cannot be eliminated within a reasonable time; - corrective actions have not been performed or have not yielded results within the period established by the decision to suspend the validity of the certificate of conformity. 7.2. The adopted decision is drawn up by the certification body in one of the forms given in Appendix D and sent to the certificate holder, to the central body of the certification system for homogeneous products or Gosstandart of Russia, and for products certified according to the mandatory requirements of standards, the decision is also sent to the territorial body of Gosstandart of Russia at the location of the manufacturer.

Appendix A.
Design and presentation of a surveillance program

1. The inspection program, as a rule, includes the following sections: 1) General information 2) Purpose of inspection 3) Object of inspection 4) Product identification 5) Tests 6) Inspection of production 7) Compliance with the terms of the license for the use of the conformity mark 8) Results of the inspection. Depending on the type and purpose of the inspection, the certification scheme, the nature of the preliminary information, individual sections can be clarified, excluded or new sections introduced. 2. In the section "General information" the following is given: - details of the manufacturer of the product and the holder of the certificate; - the place and timing of the inspection; - type of inspection (periodic, unscheduled). 3. In the section "The purpose of the check" indicate: - the main purpose of the check in accordance with clause 4.1 .; - additional tasks that can be solved during inspection control (identification of reasonable comments from consumers about the quality of certified products, determination of the possibility of retaining certificates of conformity in the presence of deficiencies discovered by state control and supervision bodies, etc.). 4. In the section "Object of inspection" the following is given: - the name and designation of the certified products, OKP and TN VED codes, the normative document according to which it is issued; - number of the certificate of conformity, date of issue, validity period and name of the authority that issued it; - the volume of certified products. 5. In the section "Product identification", tasks are established to check: - keeping in the current technical documentation for the product the requirements for which it was manufactured for its certification and the conformity of the product to this documentation; - compliance of the current regulatory documents with the requirements for which the products have been tested and certified. Initial materials: certificate of conformity: Information indexes of standards; normative, design and technological documentation for products. 6. In the "Tests" section, on the basis of normative documents for test methods, tasks are established: - to determine the volume of the sample, the rules and the place of sampling (depending on the certification scheme); - to determine the scope and conditions of tests; - by determining the place of testing (accredited laboratory, manufacturer's testing base, etc.); - to determine the possibility of using, in whole or in part, the results of previously conducted tests (periodic, typical); - on the organization of delivery of samples to the test site, ensuring their safety, including the preservation of properties, exclusion, substitution, etc. Initial materials: normative documents for test methods; sampling techniques (if any); reports of previous tests; operational documentation for products. 7. In the section "Inspection of production", depending on the certification scheme, set tasks: - for the analysis of complaints, claims of consumers and deficiencies identified during inspections by the state control and supervision bodies; - to control the stability of production conditions and the functioning of the quality system (for certification schemes 5 and 6); - to assess the preservation of the production conditions of certified products, ensuring the stability of the product indicators for which it was certified (for certification schemes 2 a, 3 a, 4 a). Initial materials: design and technological documentation; claims and complaints; production verification techniques; quality systems (production) certificates; product quality management standards. 8. In the section "Compliance with the terms of the license for the use of the conformity mark", tasks are established to control: - the presence of the conformity mark on the manufactured products that meet the requirements for which it was certified; - the correctness of the application of the conformity mark on certified products; - the correctness and regularity of payments for the right to use the conformity mark and for compliance with other license conditions. Initial materials: license for the right to use the conformity mark; inspection control contract; documents confirming payment for the use of the license; technical documentation for products. 9. In the section "Inspection Results", they give recommendations on summarizing the results, including drawing up an inspection report, its content, and the need to issue interim conclusions on sections of the program.

Appendix B.
Sampling Certificate Form

name of the certification body

ACT
sampling
dated "___" _________ 199__

the name of the enterprise (organization) where

representative

sampling is in progress

Name

certification body (territorial body, testing

laboratory), position, surname, name, patronymic

in the presence

positions, surnames, initials

representatives of the enterprise (organization) at which the sampling is carried out

selected samples of ready-to-sell products to check for compliance with the requirements

Representative of a certification body (territorial body, testing laboratory)

initials, surname

Sampling participants

position

initials, surname

position

initials, surname

Appendix B
Inspection report form

ACT N
inspection check

for certified products				name and designation		"___" __________ 199__		G.____________________

In the period from _________ 199_. until ___________ 199_ on the basis of an inspection team consisting of: conducted an inspection in accordance with the approved program

manufactured

name of the manufacturer, holder of the certificate 1)

on

name and designation of the regulatory document

certified for compliance

name designation of a normative document

Product samples are tested

name of the testing laboratory (base)

on

name designation of a normative document for test methods

During the audit, it was established: Recommendations for eliminating the identified deficiencies and developing corrective measures to eliminate them.

Conclusion

general assessment of the conformity of products with established

requirements, the state of its production, the possibility of preserving

validity of the certificate of conformity

Applications:

reports, tests, conclusions on the condition

production

1) if the manufacturer is not the owner of the certificate of conformity 2) in column 1 indicate the sections, programs containing tasks 3) in column 2, conclusions are given on specific tasks of the corresponding section of the program

Appendix D
Forms of decisions based on the results of inspection control

Form 1

SOLUTION N

product name and designation

"___" __________ 199__

G.____________________

Form 2

SOLUTION N
based on the results of inspection control over certified products

product name and designation

"___" __________ 199__

G.____________________

Based on the inspection report (N ... from ...) and the results of the analysis of information about

DECIDES

1. To suspend the validity of the certificate of conformity N… dated "___" ___________ 199__. until "___" _________ 199__ 2. To suspend the license to use the conformity mark N… dated "___" __________ 199__. until "___" _________ 199_year 3. Take corrective measures to eliminate the identified deficiencies by "___" ___________ 199__. implementation of corrective measures from "___" ____________ 199__.

Form 3

SOLUTION N
based on the results of inspection control over certified products

product name and designation

"___" __________ 199__

G.____________________

Based on the inspection report (N ... from ...) and the results of the analysis of information about

DECIDES

1. To revoke the validity of the certificate of conformity N ... from ... and the license to use the conformity mark N ... from ... from "_" ______ 199_g. 2. Publish information about the cancellation of the certificate of conformity in

8. INFORMATION DATA

1. DEVELOPED BY THE VNIIS OF THE STATE STANDARD OF RUSSIA DEVELOPERS M.V. Averin and E.I. Taver, A.L. Terkel (scientific advisor), S.Kh Roshko (executive officer), Yu.A. Kiyashev, V.P. Sipitsyn. 2. APPROVED by the Order of VNIIS dated 9.05.94 No. 793. DEVELOPED FOR THE FIRST TIME

Inspection control of certified products carried out by the Body for Confirmation of Conformity (Certification) of Products (OS), which issued the certificate of conformity. CB conducts inspection control, if it is provided for by the certification scheme, during the entire validity period of the certificate of conformity.

The purpose of the inspection control is to establish that the manufactured products continue to meet the requirements for which they have been certified. Inspection control is carried out, as a rule, at least once a year in the form of periodic and unscheduled inspections, including tests of product samples and other checks necessary to confirm compliance, i.e., that the products sold continue to meet the established requirements, confirmed by certification. Inspection control can be planned and unscheduled.

Scheduled inspection control is carried out, as a rule, no earlier than 6 months from the date of issuance of the certificate. Subsequent inspection controls shall be carried out no later than 12 months from the date of the previous inspection control. The criteria for determining the frequency and scope of inspection control are:

• the requirements of the Technical Regulations of the Customs Union;
• the degree of potential hazard of the product;
• stability of production, production volume, availability of a quality management system in production, etc.

INSPECTION CONTROL AS A RULE INCLUDES 5 STEPS:

• First stage- formation of an inspection commission, with the appointment of the chairman of the commission. The chairman of the commission draws up a plan for conducting an inspection control. Forms a commission. Coordinates with the manufacturer the time of the inspection control.
• Second phase- includes the analysis of incoming information about the certified products of the enterprise.
• Third stage- departure of the commission to the enterprise and verification of compliance with the production conditions necessary for the release of products of stable quality.
• Fourth stage- selection of samples, testing of products in an accredited testing laboratory and analysis of test results.
• Fifth stage- includes the registration of the results of control by an act in which an assessment of the test results of samples, other verification issues is given and a conclusion is made on the state of production of certified products and the possibility of maintaining the validity of a previously issued certificate of conformity.

The act is stored in the OS in the "file" of the certificate of conformity, and is also sent to the manufacturer of the product.

Based on the results of the inspection control, the CB can suspend or cancel the validity of the certificate of conformity, in case of non-compliance of the certified products with the requirements of regulatory documents, in the following cases:

• negative product test result;
• changes by the manufacturer of the regulatory document for products, without notifying the OS;
• changes in design, completeness of products, production technology without notifying the OS;
• non-fulfillment of product test methods, without agreement with the CB.

Unscheduled inspection control is carried out in the following cases:

• receipt of information on claims to the quality of certified products from consumers, executive authorities, public associations consumers, etc .;
• when the applicant applies for an inspection control due to changes in his activities related to certification requirements and restrictions on the scope of the certificate of conformity.

The results of unscheduled inspection control are also formalized in an act.

Foreword

The goals and principles of standardization in the Russian Federation are established by the Federal Law of December 27, 2002 No. 184-FZ "On technical regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic provisions "

Information about the standard

1 DEVELOPED by the Open Joint Stock Company All-Russian Scientific Research Institute of Certification (JSC VNIIS)

2 INTRODUCED by the Technical Committee "Quality Management and Conformity Assessment" (TC 079)

3 APPROVED AND PUT INTO EFFECT by Order of the Federal Agency for Technical Regulation and Metrology No. 615-st dated November 30, 2010

4 INTRODUCED FOR THE FIRST TIME

5 This standard implements the norms Federal law"On technical regulation" (Articles 2, 25, 26, 28, 34)

Information on changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments - in the monthly published information indexes "National Standards". In case of revision (replacement) or cancellation of this standard, the corresponding notice will be published in the monthly published information index "National Standards". The relevant information, notice and texts are also posted in the public information system - on the official website of the national body of the Russian Federation for standardization on the Internet

1 area of ​​use 3 Terms and definitions 4 General 5 Types, timing and scope of inspections 6 Preparation and performance of work on inspection control 7 Adoption and execution of decisions based on the results of inspection control Bibliography

Introduction

National Standard of the Russian Federation “Conformity Assessment. Inspection control of certified products "is included in the System of Standards for Conformity Assessment, which is similar in purpose and principles to the international system of standards ISO / IEC 17000 series.

Under the conformity assessment in the international standard ISO / IEC 17000: 2004 “Conformity assessment. Vocabulary and General Principles ”is understood as evidence that specified requirements for a product, process, system, person or body are met.

The national standards included in the System of Standards for Conformity Assessment are harmonized with the corresponding international standards ISO / IEC 17000 series to the extent that their effective application on the territory of the Russian Federation is possible.

This national standard has been developed taking into account the provisions of the Federal Law "On Technical Regulation", the Procedure for Conducting Certification in the Russian Federation, Recommendations for Inspection Control of Certified Products R 50-601-43-94, ISO / IEC Guide 67: 2004 "Conformity Assessment - Fundamentals Product Certification ”, ISO / IEC Guide 28: 2004“ Conformity Assessment - Guidelines for a Third Party Product Certification System ”.

This National Standard develops the provisions national standard GOST R 53603-2009 “Conformity assessment. Product certification schemes in the Russian Federation "in terms of the element of the certification scheme - inspection control.

It is aimed at creating a common approach to the inspection control procedures for certified products, contributing to the achievement of constant compliance of manufactured products with the requirements confirmed by the certificate of conformity.

The standard can be used in mandatory and voluntary certification.

GOST R 54010-2010

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

Conformity assessment

INSPECTION CONTROL
FOR CERTIFIED PRODUCTS