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The Certification Body for Product Certification (Notified Body 1781)

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The Certification Body for Product Certification (Notified body 1781 ) operates at the Slovak Institute of Metrology and its activities are in accordance with the criteria and requirements:

  • standard STN EN ISO/IEC 17065:2013 "Conformity assessment. Requirements for organizations certifying products, processes and services (ISO/IEC 17065:2012)" (referred to in the text only as ISO/IEC 17065),
  • Act No. 56/2018 Coll. on product conformity assessment, making a designated product available on the market and amending and supplementing certain acts
    • Regulation of the Government of the Slovak Republic No. 145/2016 Coll. on making measuring instruments available on the market as amended by Regulation of the Government of the Slovak Republic No. 328/2019 Coll. and
    • Regulation of the Government of the Slovak Republic No. 126/2016 Coll. on the making available of non-automatic weighing instruments on the market as amended by the Government Regulation of the Slovak Republic No. 330/2019 Coll.

Authorized and notified body

The Slovak Institute of Metrology is listed as notified body 1781 in the European Commission's NANDO information system

The Slovak Institute of Metrology is:

  • a notified body with the assigned identification number 1781 (resp. Authorized body SKTC-102) for conformity assessment of measuring instruments according to Directive of the European Parliament and of the Council No. 2014/32/EU of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments , as amended by Regulation of the Government of the Slovak Republic No. 145/2016 Coll. on the making available on the market of measuring instruments , as amended by Regulation of the Government of the Slovak Republic No. 328/2019 Coll.

The authorized and notified body (SMÚ) updates the database of measuring instrument types and approved quality management systems of measuring instrument manufacturers issued by the Slovak Institute of Metrology,  available at https://certifikaty.unms.sk/.

 

Notified body 1781 performs conformity assessment and certification of products/measuring instruments within the specified scope.

Scope of notification / authorization

No. Product Standards, regulations Procedures/ Modules
1. Water Meters Directive 2014/32/EU – Annex No. I, Annex No. III (Government of the Slovak Republic No. 145/2016 Coll. - Annex No. 1 and Annex No. 3);
EN 14154-1; EN 14154-2; EN 14154-3;
EN ISO 4064-1; EN ISO 4064-2; EN ISO 4064-3; EN ISO 4064-4; EN ISO 4064-5;
OIML R 49-1; OIML R 49-2; OIML R 49-3;
PP 01/CV; PP 06/CV; PP01/CQM;		 Modules
B, F, D, H1
2. Gas Meters and Volume
 Conversion Devices		 Directive 2014/32/EU, Annex No. I, Annex No. IV (Government of the Slovak Republic No. 145/2016 Coll. - Annex No. 1 and Annex No. 4);
EN 1359; EN 1359/A1; EN 12480; EN 12480/A1; EN 12261; EN 12261/A1; EN 12261/AC;
EN 12405-1/A2; EN 14236; OIML 137-1;
PP 01/CV; PP 05/CV; PP 01/CQM;		 Modules
B, F, D, H1
3. Active Electrical
 Energy Meters		 Directive 2014/32/EU, Annex No. I, Annex No. V (Government of the Slovak Republic No. 145/2016 Coll. - Annex No. 1 and Annex No. 5);
EN 50470-1; EN 50470-2; EN 50470-3; EN 62053-52; EN 62058-11; EN 62058-21; EN 62058-31;
EN 62059-32-1;
PP 01/CV; PP 08/CV; PP 01/CQM;		 Modules
B, F, D, H1
4. THERMAL ENERGY METERS:
 - Flow sensor (heat meter
 subassembly)
 		 Directive 2014/32/EU, Annex I, Annex VI (Government of the Slovak Republic No. 145/2016 Coll. - Annex 1 and Annex 6);
EN 1434-1; EN 1434-2; EN 1434-4; EN 1434-5;
OIML R 75-1; OIML R 75-2;		 Modules
B, F, D
5. Measuring Systems for the Continuous and Dynamic Measurement of Quantities of Liquids Other than Water Directive 2014/32/EU, Annex I, Annex VII (Government of the Slovak Republic No. 145/2016 Coll. – Annex 1 and Annex 7);
OIML R 117-1; OIML R 117-2; OIML R 118; OIML D 11;
PP 01/CV; PP 07/CV; PP 01/CQM;		 Modules
B, F, G, D
6. Material Measures -
 Capacity serving  measures		 Directive 2014/32/EU, Annex No. 1, Annex No. X, Chapter II (Government of the Slovak Republic No. 145/2016 Coll. – Annexes No. 1 and
Annex No. 10 Chapter II);
OIML R 138;
PP 01/CV; PP 16/CV; PP 01/CQM;		 Module
D1

 

Conformity assessment procedures

Government Regulation of the Slovak Republic No. 145/2016 Coll. on the making available on the market of measuring instruments as amended by Government Regulation of the Slovak Republic No. 328/2019 Coll.

  • Module B - EU-type examination
  • Module F - Conformity to type based on product verification
  • Module G - Conformity based on unit verification
  • Module D - Conformity to type based on quality assurance of the production process
  • Module D1 - Quality assurance of the production process
  • Module H1 - Conformity based on full quality assurance plus design examination

 

Documents on compliance with requirements

Testing laboratory of the Slovak Institute of Metrology

Information on carrying out conformity assessment

The notified body is independent in relation to customers and the adopted product assessment procedures ensure independent and impartial assessment in a non-discriminatory manner.

In order to ensure the above requirements, including their updating, and to monitor compliance with the established principles in accordance with the criteria of EN ISO/IEC 17065 and EN ISO/IEC 17021-1, the following principles for assessing product conformity have been adopted by the notified body (NB):

  • The general principles of the organization, assessment procedures and criteria for the evaluation of products and the manufacturer's management system are set out in the quality manual of the certification body for product certification.
  • Particular attention is paid to the procedures adopted for the assessment and certification of products and the certification of the production process management system. The aim is to ensure independent and impartial assessment of products, the application of assessment procedures in a non-discriminatory manner and a comparable method of verification.
  • The staff of the NB are independent of commercial and other interests and of any current and/or previous links to the customer.
  • The notified body shall not use any procedures that make it difficult or restrict customers' access to certification and conformity assessment.
  • The notified body shall not supply or propose to the applicant for a product activities of such a kind that it certifies the product at the same time and shall not provide advice or consultancy services to the applicant on methods of resolving issues that are obstacles to its certification process.
  • The employees of the Slovak Institute of Metrology who participate in tasks related to conformity assessment are not designers, manufacturers, suppliers or users of measuring instruments. They do not offer or provide management system consultations to manufacturers.

Receiving and review of certification application, conformity assessment

The application for conformity assessment, completed in all points, shall be submitted by the manufacturer or the manufacturer's authorized representative in person or by post. Together with the application, the applicant shall submit documentation to the extent specified in the relevant conformity assessment procedure pursuant to the Government Regulation.

GO TO Documents for download

The applicant for certification shall provide at least the following information:

  • organizational affiliation, name, address and legal status,
  • definition of the products to be certified, procedure/module and standards according to which the product is to be certified,
  • information regarding the quality system.

The completed application with the relevant documentation shall be submitted in person or sent by registered mail to the address of the Slovak Institute of Metrology stated in the header of the application. The application and related documents shall be prepared in the Slovak language or a language accepted by the authorized/notified body (AB/NB).

The assessment shall be initiated only after the submission of complete documents necessary for the conformity assessment and the required number of measuring instruments within the specified deadline.

The representative of the AB/NB shall assess the potential client's application for conformity assessment and verify its material relevance in relation to the scope of the valid authorization/notification. If the institute is not authorized/notified for the requested conformity assessment, the application will be forwarded back to the client with a written justification.

Before the assessment itself, the Notified body 1781 representative will review the certification application and ensure that:

  • the information about the customer and the product for the implementation of the certification is sufficient, i.e. the certification requirements are clearly defined, documented and understood,
  • any difference in views between the certification body and the applicant has been clarified, including agreement on standards or other normative documents,
  • the scope of the requested certification has been properly defined,
  • the application has been signed by an authorized person,
  • the means are available to carry out all assessment activities,
  • the Notified body 1781 is capable of providing the service in the area of ​​the requested certification and with regard to special requirements (for example, the language used by the applicant).

If the application meets the requirements necessary for product certification and the certification body is able to provide the requested certification, the Notified body 1781 director will decide on the acceptance of the application.

If deficiencies are found during the verification of the correctness and completeness of the application and the required documentation, the representative of the AB/NB will specify them and ask the client to eliminate them. Depending on the extent of the deficiencies, the client will be given an appropriate deadline to eliminate them. If the deficiencies have not been eliminated, he may request their elimination again. If the applicant does not submit documents proving compliance with the requirements within the specified deadline, the Director of Notified body 1781 will decide to reject the application.

 

Information about the product evaluation process

The procedure for certifying a measuring instrument, depending on the conformity assessment procedure, mainly includes the review of technical documentation, testing of the measuring instrument and the assessment of conformity with the relevant requirements according to the regulations and standards that apply to the product in question. The NB carries out the assessment of individual products on the basis of applicable standards and regulations. The scope, procedure and method of conducting the tests are decided by the NB employee responsible for the specific certification of the measuring instrument.

In the certification process, the NB uses the services of the accredited testing laboratory of the Slovak Institute of Metrology , which meets the requirements of the EN ISO/IEC 17025 standard and has proven traceability to national standards implementing units in accordance with the International System of Units (SI) and in accordance with the agreement on the mutual recognition of national standards and calibration certificates and measurement results issued by national metrology institutes.

The procedure for assessing the manufacturer's quality system includes, in particular, an assessment of the quality system according to the submitted documentation, an inspection visit to the manufacturer's premises and verification of the functionality of the quality system and verification of the conditions for carrying out the tests of measuring instruments. When assessing the quality system of the production process, a quality system certificate according to EN ISO 9001 may be used, or when verifying the conditions for carrying out the tests of measuring instruments, an accreditation certificate according to EN ISO/IEC 17025.

The representative of the NB shall provide the applicant with relevant information about the members of the audit team in sufficient time to allow the applicant's organization to raise objections to the appointment of any auditor or technical expert. He shall inform the client about the audit plan and agree in advance with the client's organization the audit dates.

The assessment shall only be started after the submission of complete documents necessary for the conformity assessment and the submission of the required number of measuring instruments within the specified deadline.

 

Review of assessment results and certification decision

The certification decision is made by the Notified body 1781 based on a review of the information and assessment results obtained during the assessment process and, where appropriate, other relevant information. If the decision is based on information outside the assessment source, this is communicated to the client together with information about the assessment process, with the opportunity to comment on it. The certification decision is essentially made by the Notified body 1781 alone. The review and decision are carried out by persons other than those involved in the assessment process.

 

Certificate award

In the case of a positive decision (only if all nonconformities have been eliminated and corrective actions have been verified), a certificate is issued. The certificate is issued in the name of SMÚ - an authorized/notified body (in the case of conformity assessment under Slovak legal regulations or European directives of the "New Approach"). The validity of the certificate is determined according to the relevant certification scheme or applicable regulation. The Notified body 1781 informs the client of the certification result (whether positive or negative) only after the certification decision has been made.

Supervision

In order to ensure continuous compliance with the product characteristics that are the basis of the certificate, the Notified body 1781 carries out regular surveillance assessments of production, testing facilities and quality assurance measures at the expense of the certificate holder.

The form and method of surveillance depends on the certification scheme used. The frequency is given by the relevant certification scheme.

In addition, an extraordinary surveillance may be carried out between regular surveillances:

if it is found that the client does not comply with the conditions under which the certificate was granted, or as a result of a complaint;
if the client requests a change in the scope of an already granted certification;
if the changes notified within the framework of the client's obligations are so extensive that the issued certificate no longer has any conclusive value.

The certificate holder must ensure that the certification body has the opportunity to inspect the production sites specified in the certificate, operations and warehouses (for foreign certificate holders also the warehouses of Slovak authorized representatives and branches, for importers also their warehouses) at any time, without prior notice (during normal operating hours) and to take the necessary quantity of products for which the certificate was issued free of charge for the purpose of physical assessment and testing, even if these are not its own production and operation sites.

Notified body 1781 may withdraw products for which the certificate/certification mark has been issued from the market for the purpose of inspection. If the requirements serving as the basis for the certificate are not met, e.g. as a result of inadmissible changes that are, or could be, the cause of suspension/withdrawal of the certificate, the certificate holder shall cover the costs of product assessment and/or audit of the production site.

Changes and modifications

The client must immediately inform the Notified body 1781 of any changes that affect compliance with the certification requirements (e.g. change of ownership, legal or organizational status, change of organization and management, change of product or production method, significant changes in the quality management system, change of production site or address). This circumstance may make the continuation of the certificate dependent on the manufacturer's proof of compliance with the conditions under which the certificate was granted or on an additional assessment.

Expiration, withdrawal and suspension of the certificate

The certificate expires if:

  1. the period specified on the certificate has expired,
  2. a court decision has been made to declare bankruptcy on the certificate holder's assets,
  3. the certificate holder has discontinued its business activities,
  4. the company has been taken over by another entity or a third party has taken over the rights of the certificate holder,
  5. the legal requirements, standards or other normative documents against which the product's conformity was assessed are changed or revoked.

Notified body 1781 has the right to suspend the validity of the certificate if:

  1. the supervision cannot be carried out within the due date for reasons arising from the client, and at the same time the client requests in writing to postpone the supervision and Notified body 1781 decides positively after considering the reasons. The suspension of the certificate lasts until the supervision is properly carried out, the date of which is fixed. After the expiry of the specified period, either the renewal phase occurs when the above conditions for the duration of the product certificate are met or the certificate is withdrawn;
  2. it is proven during the supervision that some of the prerequisites for product certification are no longer applied by the certificate holder, and at the same time Notified body 1781 can rightfully assume that the non-conformities will be eliminated within the specified period. If this deadline is not met for reasons arising from the client, the certificate withdrawal phase occurs;
  3. the suspension is requested by the customer (e.g. in the case of a temporary stoppage of production).

Notified body 1781 has the right to withdraw the certificate if:

  1. there is misleading or other unacceptable advertising through the certificate or its misuse, or the legal provisions are not complied with when placing the product on the market;
  2. non-conformities have been found in the product, the products no longer comply with the certified product, or the essential requirements of the certified product are no longer ensured;
  3. the certificate holder rejects in writing changes to the general terms and conditions, or these general rules for product certification or the SMÚ price list, or the possibility of familiarizing themselves with them;
  4. the product no longer meets the basic requirements, so that the consumer, user or third parties are exposed to a non-negligible risk, or the product does not fulfill the purpose specified by the manufacturer and this deficiency is not eliminated within the specified period;
  5. the assessment of production, testing facilities, warehouses or testing of products was not allowed or the products were not made available within the specified period. The same applies if it was not, or despite a written request, supervision could not be carried out for reasons arising from the certificate holder;
  6. despite written warnings, SMÚ's claims against the certificate holder were not paid within the specified period; this also applies in the case of partial non-payment of claims;
  7. the certificate holder violates the applicable General Terms and Conditions or General Rules for Product Certification, which is not just a case of slight negligence or a minor offense;
  8. corrective measures and/or suspension of certification have had no effect;
  9. the certificate holder requests cancellation or withdraws from the agreement;
  10. SMÚ is not liable to the client (certificate holder) for damages incurred by the non-grant, withdrawal, suspension or expiration of the certificate.

Applicant/ Manufacturer Obligations

The manufacturer must take all measures to ensure the conformity of the measuring instrument with the relevant requirements of the government regulation. He assumes responsibility for ensuring the conformity of the manufactured measuring instrument with the approved type and the relevant requirements of the standards and regulations.

The manufacturer is obliged to:

  • inform the NB of all planned changes to the certified product, or of the certified management system,
  • demonstrate the conformity of the certified product or certified management system only with the relevant requirements specified in legislative documents and standards,
  • refer to the certification only to the extent of the certification granted,
  • not use the certification in a manner that could damage the reputation of the NB and not make any statements that the NB could consider misleading or unauthorized,
  • in the event of suspension or withdrawal of certification, cease to exercise all certification authorizations and return the relevant NB certificate,
  • allow the NB for the purpose of certification and inspection, review of the necessary documentation, access to all premises and records,
  • keep and maintain records of all complaints submitted regarding the conformity of products with the requirements of the relevant standard,
  • take appropriate corrective measures in connection with the complaint to eliminate any deficiencies found in the products that affect compliance with the certification requirements,
  • take and document corrective actions,
  • ensure that no certificate or report or part thereof and marks of conformity are used in a misleading manner.

Complaints and Appeals

Complaint Handling Process

Notified body 1781 has a documented procedure and rules for handling complaints. The procedure for submitting, receiving, recording and handling complaints to Notified body 1781 is in accordance with the procedure set out in OS-16 Handling of Complaints and Petitions to the extent corresponding to the activities of Notified body 1781 . The rules for handling complaints and appeals are part of the application for certification.

After receiving a complaint, the Notified body 1781 Director or a person authorized by him/her will assess whether the complaint concerns certification activities for which Notified body 1781 is responsible. If the complaint is justified, further action will be taken in accordance with the procedure set out in OS-16 Handling of Complaints and Petitions to the extent corresponding to the activities of Notified body 1781 .

Notified body 1781 will confirm receipt of a formal complaint to the sender with a cover letter. The Notified body 1781 Quality Manager is responsible for the process of receiving complaints and records them in the Complaints and Appeals Register.

The Notified body 1781 Director or his/her designee is responsible for collecting and verifying all necessary information in order to proceed with the complaint for decision.

The Notified body 1781 Director is responsible for evaluating complaints and making decisions. If the complaint concerns the Notified body 1781 Director, the Notified body 1781 Committee Chairman is responsible for evaluating and making decisions. Given the fact that this process concerns the complainant and the subject of the complaint, all persons involved in the process respect confidentiality requirements.

In order to avoid a conflict of interest, Notified body 1781 employees (including employees acting in managerial positions) who provided advice to the client or were used by the client in an employment relationship cannot be Notified body 1781 employees for reviewing or approving the resolution of the complaint for this client for a period of 2 years from the end of the advice or employment.

Within 10 days from the date of receipt of the complaint, the Notified body 1781 administrative employee/quality manager informs the complainant about its registration (reception, delivery). The Notified body 1781 shall investigate the complaint within 30 days of its submission and shall provide the complainant with a report on the outcome of the resolution.

The decision, which shall be communicated to the person who filed the complaint, shall be prepared or reviewed and approved by a person designated by the Notified body 1781 Director who has not previously been involved in the subject matter of the complaint. The Notified body 1781 Director shall provide the complainant with an official report on the completion of the complaint handling process.

The Notified body 1781 Director shall take the necessary follow-up action if the complaint was justified.

The costs associated with resolving the complaint shall be borne by the entity filing the complaint only if the complaint was not justified.

Appeals Process

Any client who is dissatisfied with the Notified body 1781 decision for any reason may appeal against this decision within 15 days of its delivery. The client shall address the appeal against the Notified body 1781 decision to the Notified body 1781 Director. The rules for handling complaints and appeals are part of the certification application.

The Notified body 1781 will confirm the receipt of the appeal to the sender by a cover letter within 10 days of the date of receipt of the appeal. The Notified body 1781 quality manager is responsible for the process of receiving appeals and records them in the Complaints and Appeals Register. The Notified body 1781 Director decides on the merits of the appeal and the method of handling it within 30 days of its submission. The Notified body 1781 Director will review all the facts stated in the appeal, taking into account the results of previous similar appeals.

A written decision on the appeal with justification will be prepared, reviewed and approved by the person(s) who were not previously involved in the subject of the appeal (the Notified body 1781 committee or the commission appointed by the Notified body 1781 committee - the appeal commission).

a) If the appeal was justified, the Notified body 1781 Director shall issue a new decision and cancel the previous (disputed) decision. At the same time, he shall decide on the adoption of appropriate correction and implementation of corrective actions to prevent the deficiency in question from recurring. At the same time, he shall determine the deadline and the person responsible for the implementation of corrective actions.

b) If the Notified body 1781 did not accept the appeal, the Notified body 1781 Director shall issue a negative decision.

In cases of disagreement of the client with the solution implemented by the Notified body 1781 Director, the appeal shall be reviewed by the Notified body 1781 Committee. To review the appeal, a working group - the appeal commission, whose composition shall be notified to the client. The Notified body 1781 Committee may adjust the composition of the commission based on the client's objection.

As part of the appeal procedure, which will be handled by the Notified body 1781 Director or Committee, the entity submitting the appeal shall have the opportunity to participate in the discussion regarding the resolution of its appeal.

All persons involved in the appeal process shall respect confidentiality requirements.

To avoid a conflict of interest, Notified body 1781 employees (including those in managerial positions) who provided advice to a client or were employed by the client may not be used by Notified body 1781 to investigate an appeal for that client for a period of 2 years from the end of the advice or employment.

The filing, review and decision on an appeal may not result in any discriminatory actions against the person who filed the appeal.

Prices for certification, conformity assessment

Certification prices are determined according to the valid price list of the SMU, based on individual calculation. The price is determined based on the hourly rate and time labor expressed in hours. Prices include the costs of performing tests, evaluation, performing self-certification and payment for external subcontracts (if implemented).

The agreed price may be charged for extraordinary costs associated with the transport of the standard equipment to the applicant's headquarters, actual travel costs, or other extraordinary costs. The costs will be added to the price for the service and their specification attached to the invoice.

Information about the assessment process and assessment prices can be obtained from the NB representative (tel.: +421/2/602 94 337; e-mail: mazur@smu.gov.sk).

Financing of Notified body 1781 activities

Notified body 1781 has financial resources secured from its own activities and from the budget of the SMÚ.

Certification Department contacts


Company ID Number, VAT ID number, Bank account number are identical to the organization's data. The founder of the certification body is the Slovak Institute of Metrology, Notified body 1781 is not an independent legal entity. The certification body for product certification is organizationally integrated into the Certification Department.