Prepared by the Ministry of Industry and Technology; The Communiqué on Basic Criteria to be Based on the Appointment, Monitoring and Inspection of Notified Bodies was published in the Official Gazette No. 30898 on September 24, 2019.

The entire regulation is as follows;

Goal

ARTICLE 1 - (1) The purpose of this Communiqué is to determine the basic criteria for the assignment, monitoring and supervision of notified bodies that will operate under the technical regulations under the authority and responsibility of the Ministry of Industry and Technology.

Scope

ARTICLE 2 - (1) This Communiqué deals with the qualifications required by notified bodies to operate within the scope of the technical regulations falling within the responsibility of the Ministry of Industry and Technology, the criteria to be assigned based on their assignments, the obligations and notifications of notified bodies, and the implementation of administrative sanction decisions. It covers the procedures and principles.

Rest

ARTICLE 3 - (1) This Communiqué;

a) Article 7 of the Law on the Preparation and Application of the Technical Legislation on Products dated 29/6/2001 and numbered 4703,

b) Article 388 of the Presidential Decree on the Presidential Organization No. 1, published in the Official Gazette No. 30474 dated 10/7/2018,

c) Regulation on Conformity Assessment Bodies and Notified Bodies enacted by the Council of Ministers Decision dated 16/12/2011 and numbered 2011/2621,

prepared on the basis of.

Definitions and abbreviations

ARTICLE 4 - (1) In this Communiqué;

a) EU: European Union,

b) Ministry: Ministry of Industry and Technology,

c) Information System: Software infrastructure created by the Ministry for notified body activities,

ç) Extending the scope: Adding new conformity assessment methods to the conformity assessment methods in the relevant technical regulation in which the notified body is assigned,

d) Notified bodies: Conformity Assessment Bodies by the competent authorities to file a technical regulation within the scope of conformity assessment activities and Notified Bodies Regulations and appointed in accordance with the principles set out in the relevant technical regulations and the names of the Commission reported that the built-conformity assessment bodies in Turkey

e) Technical arrangement: Any legislation that complies with the qualifications, processing or production methods of a product or related terminology, symbol, packaging, marking, labeling or conformity assessment processes one by one or more,

f) Technical regulatory officer: Personnel planning the inspection and audits to be carried out within the scope of conformity assessment activities to be carried out by the notified body in accordance with the relevant technical regulation, checking and reporting the inspection and inspection results before the certification decision,

g) Technical expert: Personnel carrying out the examinations and / or inspections planned within the scope of conformity assessment activities to be carried out by the notified body in accordance with the relevant technical regulation and presenting the inspection and / or inspection results to the technical regulatory officer,

ğ) TÜRKAK: Turkish Accreditation Agency,

h) conformity assessment bodies: calibration, testing, certification and inspection that performs conformity assessment activities including organizations located in Turkey,

express.

SECOND PART

General Principles and Qualifications to be Required in Notified Bodies

General principles

ARTICLE 5 - (1) The conformity assessment institution applying to the Ministry to perform the conformity assessment activities of the products that fall under the technical regulations under the authority and responsibility of the Ministry, is evaluated within the framework of the Law No. 4703, the Conformity Assessment Bodies and Notified Bodies, the relevant technical regulation and the principles specified in this Communiqué. and if their applications are deemed appropriate, they will be assigned as the notified body by the Ministry.

Qualifications to be sought in notified bodies

ARTICLE 6 - (1) The conformity assessment body, conformity assessment bodies and notified bodies that apply to the Ministry to be a notified body, have the qualifications set out in article 7 of the Regulation of Conformity Assessment Bodies and Notified Bodies, and fulfill the provisions of this Communiqué.

THIRD PART

Conditions Regarding Personnel, Contractor Laboratory Use and Accreditation

Personnel related conditions

ARTICLE 7 - (1) In order to maintain the inspection and / or inspections to be carried out within the framework of the conformity assessment activities to be carried out, the applicant organization shall have sufficient technical knowledge, sectoral and inspection and / or inspection experience within the scope of the technical regulations / arrangements under the application. includes the regulatory officer and technical expert.

(2) The applicant organization shall have the technical regulation officer to be assigned within the scope of the relevant technical regulation, full-time. The technical regulation officer is assigned within the scope of the technical regulations / arrangements in a group specified in Annex-1. The technical regulation officer cannot work in any other notified body appointed by the Ministry, except for the notified body.

(3) The applicant organization shall have at least two technical experts full-time within the scope of the relevant technical regulation. The technical expert is assigned within the scope of the technical arrangements / arrangements in a group specified in Annex-1. The technical expert cannot take office in another notified body appointed by the Ministry, except for the notified body.

(4) At least one-year sectoral and at least one-year inspection and / or inspection or at least two-year inspection and / or audit within the scope of technical regulations / arrangements subject to the application after completing the higher education in one of the engineering faculties or technology faculties of the technical regulation officer. or have at least three years of experience in public institutions and organizations.

(5) At least one-year sectoral or at least one-year inspection and / or audit or at least two-year public under the technical regulations / arrangements subject to the application after completing the higher education of one of the technical specialist engineering faculties or technology faculties and / or technical education faculties of universities. must have institution and establishment experience.

(6) The technical regulation officer cannot act as a technical expert.

(7) In cases where the existing workforce does not meet the workload, the notified body may use the outsourced technical specialist / specialists with whom it has contracted after receiving the Ministry's approval. The notified body determines the outsourced technical specialist, which it can use on a contract basis, without violating the technical regulation requirements, and runs it in accordance with the quality management system it has. Outsourced technical specialist provides services by signing contracts with up to two notified bodies. In case of using external technical experts, the ultimate responsibility belongs to the notified body.

(8) If the notified body leaves the job of the technical regulation officer and / or the technical specialist, he shall appoint the personnel meeting the conditions specified in the fourth and fifth paragraphs of this article and forward the documents and documents regarding the competence of the personnel to the Ministry.

(9) The notified body cannot appoint the general manager, deputy general manager, members of the board of directors and company partners as technical regulatory officers and / or technical experts.

Conditions for contractor use

ARTICLE 8 - (1) The contractor laboratory to be used by the notified body is required to be accredited according to the TS EN ISO / IEC 17025 standard.

(2) The contractor inspection institution to be used by the notified body is required to be accredited according to the TS EN ISO / IEC 17020 standard.

(3) In case the contractor laboratory and / or inspection institution is used, the ultimate responsibility belongs to the notified body.

Conditions related to accreditation

ARTICLE 9 - (1) The conformity assessment institution applying to the Ministry to become a notified body is required to be accredited for approval in accordance with the TS EN ISO IEC 17000 series standard / standards within the scope of the relevant technical regulation.

(2) The notified body applying for extension to the Ministry is required to be accredited in accordance with the TS EN ISO / IEC 17000 series standard / standards within the scope of the relevant technical regulation.

(3) Validity of accreditation for conformity assessment body or notified body, if the application was made within the scope of which technical arrangement, which product groups and / or modules, is valid for TS EN ISO / IEC 17000 series standards / standards only and / or evaluated in relation to the modules.

(4) The accreditation for approval, which the applicant organization has, must meet the requirements required by the technical regulation.

(5) Conformity Assessment Bodies and Notified Bodies in accordance with the seventh paragraph of Article 4 of the Regulation, made by TÜRKAK the accreditation of conformity assessment bodies built in Turkey. The notified body candidate conformity assessment body may apply to the national accreditation bodies of the EU member states who have successfully completed the equivalence assessment of the EU member states in areas where TURKAK does not provide accreditation services or where the equivalence assessment to which TURKAK is subject does not result in a positive assessment of the conformity requested.

SECTION FOUR

Application, Evaluation, Notification, Assignment, Monitoring and Audit

Application

ARTICLE 10 - (1) An application is made to the Ministry through the Information System with a form containing the information of the personnel authorized by following the procedures regarding the establishment so that the applicant organization can be identified in the Information System.

(2) The following information and documents are included in the Information System within the scope of the application. Requirements regarding the quality of the information and documents requested for the application are included in the Information System.

a) Scope of the application;

1) Name and reference number of the technical arrangement,

2) Defining the module or modules to be preferred as the conformity assessment method together with the attachment specified in the technical arrangement,

3) Product groups covered by the application and covered by the relevant technical regulation.

b) The general condition of the technical staff employed in accordance with the conditions laid down in Article 7;

1) Detailed staff list explaining the name, surname, field of duty and authority of the full-time staff,

2) Documents proving the educational status, sectoral or inspection and / or auditing or experience of public institutions and organizations of full-time staff.

c) The original or a notarized copy of the professional liability insurance policy made in accordance with the conditions specified in Article 20,

ç) English version of the accreditation certificate or certificates issued by TÜRKAK for approval for approval, certified by Turkish and sworn translation agencies or issued by TÜRKAK,

d) Registered electronic mail (REM) address.

(3) The application is submitted to the Ministry through the Information System in accordance with the conditions specified in this Communiqué. The application, which is not made in accordance with this condition, is rejected by the Ministry.

(4) If an application is made to perform only a part of any of the modules used in the conformity assessment to be carried out within the scope of the technical regulation subject to the application, the application in question is not evaluated and rejected by the Ministry.

(5) Applications for becoming a notified body and all work and transactions performed in accordance with notified body activities are carried out through the Information System.

Evaluation

ARTICLE 11 - (1) The application is examined by the Ministry in accordance with the relevant technical regulation and the criteria specified in this Communiqué. If a non-conformance is detected in the application, the application is rejected.

(2) The Ministry carries out the necessary inspections in the head office of the conformity assessment institution and on the field in order to make determinations and evaluations regarding the adequacy of the applicant organization. In addition, the Ministry carries out the necessary inspections in the head office of the notified body, which requests extension if necessary. In case of non-compliance in the evaluation report prepared as a result of the audit, the application is rejected due to the absence of assignment conditions.

(3) For the conformity assessment activities to be carried out within the scope of the relevant technical regulation, for the first time the applicant conformity assessment institution is taken into consideration, taking into consideration the requirements of the country's industry and the notified body of the producer, technical and legal compliance, sustainability and competition conditions, and the potential, experience and accumulation of the notified institution candidate. The Ministry shall make the final decision regarding its appointment as a notified body or a request for extension of the notified body.

(4) The application of the conformity assessment body or notified body whose investigation has been initiated due to any strong suspicion is not evaluated by the Ministry until the necessary investigation is completed.

Notification

ARTICLE 12 - (1) The term of office of the notified body is determined by the Ministry on the basis of the most recent validity date of the accreditation for the approval of the applicant organization. If there is more than one accreditation regarding the scope of application, the term of office of the notified body is determined according to the accreditation, the validity period of which will expire soon.

(2) Applicant organizations that are appointed as notified bodies or whose scope extension is deemed appropriate by the Ministry are notified to the Ministry of Commerce for their publication in the EU New Approach Notified Bodies Information System.

commission

ARTICLE 13 - (1) The applicant institution is first assigned an institution identification number registered by the European Commission, or the scope extension is included in the EU New Approach Notified Bodies Information System.

(2) The applicant organization gains the status of the notified body upon its publication by the Commission in the EU New Approach Notified Bodies Information System.

(3) The Ministry transmits the notification containing the new term determined by the Ministry of Commerce to be published in the Information System of the New Approach Notified Bodies, in order to ensure the continuity of the status of the notified body under the relevant technical regulation due to the expiration of the term of office.

(4) Regarding the notification of the new term of office, at least 30 days before the end of the current term of office, the English copies of the accreditation certificate, which is the basis for the determination of the term in question, have been renewed and translated into Turkish and sworn translation offices, or issued by TURKAK. It must have been forwarded to the Ministry.

(5) The responsibility for not being able to initiate the necessary steps regarding the notification of the new term of office of the notified body within the scope of the relevant technical regulation under the conditions specified in this Communiqué rests with the notified body.

(6) The notified body shall notify the Ministry of any changes in its activity and structural features related to the notification regarding the status of the notified body under the relevant technical regulation. The Ministry communicates the change to the European Commission through the Ministry of Trade.

(7) The Ministry shall make the final decision regarding the notification of the new term of office of the notified body, in accordance with the requirements set out in the third paragraph of Article 11.

Monitoring and control

ARTICLE 14 - (1) The inspections related to the monitoring of the adequacy of the activities carried out by the notified body within the scope of the technical regulations or regulations to which it is assigned are carried out ex officio or by the Ministry upon complaint.

(2) The Ministry can oversee the certification process of the notified body.

(3) The Ministry transmits the administrative sanction decisions applied to the Ministry of Trade as a result of the inspections and inspections it carries out.

(4) Complaints about accreditation for the purpose of approval that the notified body has are submitted to TÜRKAK by the Ministry. The results of the operations to be carried out by TÜRKAK are notified to the Ministry. As a result of the transactions carried out by TÜRKAK, the Ministry decides whether the notified body should continue its duty or not.

(5) TÜRKAK transmits the information regarding the notified body whose scope of accreditation has been narrowed, suspended and canceled for approval as a result of surveillance or accreditation renewal audits. In the event that TÜRKAK initiates the suspension process for accreditation for approval, the Ministry shall notify the start and end dates of the suspension period in question.

CHAPTER FIVE

Obligations of the Notified Body, with the Coordination of Notified Bodies

Cooperation and Branch, Representation and Contractors and Internally Accredited Units

Obligations of the notified body

ARTICLE 15 - (1) The notified body must fulfill the obligations stipulated in Articles 4, 7 and 10 of the Regulation on Conformity Assessment Bodies and Notified Bodies.

(2) Other obligations regarding the notified body are as follows:

a) To perform the conformity assessment activities to be carried out within the scope of the technical regulation that it is authorized, in a correct, complete and continuous manner,

b) Employing a sufficient number of full-time staff in accordance with the conditions set out in this Communiqué in order to perform the conformity assessment activities to be carried out within the scope of the technical regulation it is authorized for.

c) Keeping all necessary records regarding all the transactions and the documents it gives and submitting them to the Ministry for examination, if necessary,

ç) To carry out the activities related to the certification processes to be carried out with the assignment in accordance with the procedures and principles specified in the Information System,

d) Notifying the Ministry of any structural changes that will affect their activities within the scope of the procedures and powers determined within 30 days,

e) Notification of any changes regarding the contact information to the Ministry within 30 days at the latest,

f) To take all necessary measures to ensure that all manufacturers benefit from conformity assessment service under equal conditions,

g) While providing conformity assessment service, the conditions that will force market conditions, increase production costs significantly and put producers in a difficult situation are not put forward,

i) Both Turkey, as well as ensuring participation in the activities of all kinds to increase coordination and cooperation in the EU before,

h) Participating in the work of the Notified Body Coordination Group organized at the EU and respecting the guideline documents that will come out of these studies,

ı) Establishment of a mechanism to follow the developments regarding the legislation and standards within its scope,

i) Ensuring the confidentiality of the information obtained regarding the certification activities it carries out,

j) Ensuring the impartiality of the personnel to be used in conformity assessment activities and not determining the wages to be given to the personnel according to the number of evaluations made or the results of these evaluations.

(3) As a result of the conformity assessment activities to be carried out, the notified body to examine the objections and complaints that may arise in cases where the certification request for any product is rejected or if a product approval is not given or the certificate of a previously documented product is canceled;

a) To notify the manufacturer or his authorized representative in detail the reasons for the decision to refuse or withdraw approval.

b) To notify the producer or his authorized representative of the existing legal rights and the periods regarding the exercise of these rights,

c) By ensuring that the producer or his authorized representative can object to the decision, to ensure that this objection is examined by the person or persons who have no prior relationship with the said decision but who have sufficient knowledge and experience on the subject and can act independently,

ç) Notifying the Ministry and other notified bodies of information regarding the rejected or withdrawn approvals,

Are required.

(4) In the event that it is determined that the institution appointed as the institution approved by the Ministry does not comply with the criteria and conditions to be fulfilled, the Ministry suspends or cancels its assignment.

(5) The cancellation of the task of the notified body within the scope of the relevant technical regulation does not eliminate its responsibilities arising from the activities carried out by the said institution during its duty.

(6) The notified body plans the certification activities to be carried out in accordance with the procedures and principles specified in the Information System and ensures that it is implemented in accordance with the relevant plan.

 Cooperation with notified bodies

ARTICLE 16 - (1) A coordination meeting is organized under the leadership of the Ministry in order to ensure the unity of implementation in the conformity assessment activities to be carried out by the notified bodies, to evaluate the problems that arise and to provide the necessary cooperation between the notified bodies.

(2) In order to provide parallelism and cohesion among the notified institutions in order to provide the necessary coordination, information and experience sharing and conformity assessment processes, the working group is formed within the scope of each technical regulation and these studies are carried out in line with the procedures and principles determined by the Ministry. .

Branches, representative offices and contractors and internally accredited units

ARTICLE 17 - (1) The rules stipulated in Articles 13, 14 and 15 of the Regulation on Conformity Assessment Bodies and Notified Bodies about the transactions related to the branch, representative or contractor and internally accredited units of any notified body domestically or abroad.

(2) technical regulations within the Ministry's area of ​​responsibility covered branches of foreign origin or their representatives approved organizations operating in Turkey, which approved the scope and activities on behalf of the organization that carried out the information activities to the Ministry.

CHAPTER SIX

Miscellaneous and Final Provisions

Administrative sanctions

ARTICLE 18 - (1) If it is determined that the notified body does not comply with the Regulations on Conformity Assessment Bodies and Notified Bodies and the conditions and obligations specified in this Communiqué, the Ministry implements the necessary administrative sanctions within the scope of the Law No. 4703.

(2) The following administrative sanctions are applied by the Ministry regarding nonconformities and unfulfilled liabilities determined within the framework of the activities of the notified body:

a) In the event that any structural changes or the contact information changed are not reported to the Ministry within the period specified in this Communiqué, the administrative penalty stipulated in the paragraph (h) of the first paragraph of Article 12 of the Law No. 4703 is applied.

b) In the event that the certification processes carried out with the assignment are not carried out in accordance with the procedures and principles specified in the Information System, the administrative penalty provided for in paragraph (h) of the first paragraph of Article 12 of the Law No. 4703 is applied.

c) In the event that the conditions related to the personnel specified in this Communiqué are not met, the activities of the approved organization are temporarily suspended in accordance with the second paragraph of the article 9 of the Law No. 4703 and maximum 45 days are given for the corrective action. At the end of the period, if the conditions related to the personnel are not fulfilled, the status of the notified body is canceled in accordance with the third paragraph of the article 9 of the said Law.

ç) In the event that the conditions related to professional liability insurance stated in this Communiqué are not met, the activities of the establishment approved in accordance with the second paragraph of Article 9 of the Law No. 4703 are temporarily suspended and maximum 30 days are given for the corrective action. At the end of the period, if the conditions related to professional liability insurance are not met, the status of the notified body is canceled in accordance with the third paragraph of the article 9 of the said Law.

d) If the accreditation based on the Ministry by the notified body is suspended by TÜRKAK, the status of the notified body is suspended within the scope of the relevant technical regulation. At the end of the suspension period, if the accreditation for approval is not maintained by the notified body, the status of the notified body is canceled within the scope of the relevant technical regulation pursuant to the third paragraph of Article 9 of the Law No. 4703.

e) In case of the cancellation of the accreditation taken as basis by the Ministry in the notification of the notified body, the status of the notified body within the scope of the relevant technical regulation is canceled in accordance with the third paragraph of the article 9 of the Law No. 4703.

f) In case of failure to achieve independence and / or impartiality, the administrative penalty provided for in paragraph (g) of the first paragraph of Article 12 of the Law No. 4703 shall be applied and the status of the notified body shall be canceled in accordance with the third paragraph of the article 9 of the said Law.

g) In case of determination of the certifications that do not comply with the technical regulation, the administrative fines stipulated in the paragraph (g) of the first paragraph of the article 12 of the Law No. 4703 are applied.

ğ) In the event that the notified body regarding the conformity assessment does not inform the Ministry that it has performed some duties to a contractor or uses a branch or agency for these works, the activities of the notified body are temporarily suspended in accordance with the second paragraph of Article 9 of the Law No. 4703 and maximum 30 days for the corrective action. time is given. In the second repetition of the same nonconformity, the status of the notified body is canceled in accordance with the third paragraph of the article 9 of the said Law.

h) The administrative fines stipulated in the paragraph (h) of the first paragraph of the article 12 of the Law No. 4703 are applied to the conformity assessment body, which acts in contradiction with the sixth paragraph of the Article 15 of this Communiqué.

(3) The administrative fines stipulated in the paragraph (h) of the first paragraph of Article 12 of the Law No. 4703 shall be applied to the conformity assessment body, which acts in contradiction with the second paragraph of Article 17 of this Communiqué.

Misuse of documents and ID numbers

ARTICLE 19 - (1) The notified body takes the necessary measures in case the identity registration number, documents and signs are used incorrectly and / or improperly.

Professional liability insurance

ARTICLE 20 - (1) Within the scope of the professional liability insurance of the conformity assessment institution that will make the application for the notified body, reference is made to the relevant technical regulation and the general financial value of the insurance policy is at least 1.000.000 TL. However, in the case of an application to be approved by the conformity assessment body within the scope of more than one technical arrangement or in the scope extension application to be made by the notified body within the scope of different technical regulations, the value of the said insurance policy is increased by at least 500.000 TL for each technical arrangement.

(2) contains all of the geography of Turkey and the EU member states in terms of minimum professional liability insurance coverage.

(3) Continuity of professional liability insurance is ensured as long as the status of the notified body continues.

Cases without provisions

ARTICLE 21 - (1) For the matters not mentioned in this Communiqué; The provisions of the Law No. 4703, the Regulation on Conformity Assessment Bodies and Notified Bodies and the relevant technical regulations are applied.

Legislation repealed

ARTICLE 22 - (1) The Communiqué on the Basic Criteria to be Based on the Assignment, Monitoring and Inspection of the Institutions Approved by the Ministry of Science, Industry and Technology, published in the Official Gazette dated 3/8/2013 and numbered 28727 (SGM: 2013/12). References to the Communiqué are deemed to have been made to this Communiqué.

Staff

PROVISIONAL ARTICLE 1 - (1) The provision regarding the company partners in paragraph 7 of article 7 cannot be appointed as the technical regulation officer and / or technical expert, does not apply until the date of 1/1/2020 for the scope and personnel of the notified bodies appointed by the Ministry.

Force

ARTICLE 23 - (1) This Communiqué enters into force on the date of publication.

Executive

ARTICLE 24 - (1) The provisions of this Communiqué are executed by the Minister of Industry and Technology.