Guide to application of the ATEX 2014/34/UE directive - ANNEX IV MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

ANNEX IV

MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1.           Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.

§ 189  Conformity to type based on quality assurance of the production process

Module D “Conformity to type based on quality assurance of the production process” as Annex IV to the ATEX Directive 2014/34/EU (indicated as “Production quality assurance” in the previous Directive 94/9/EC) is one of modules that may be applied after the Module B (EU-type examination certificate, Annex III).

This conformity assessment procedure operates a quality system approved by a notified body for production, final equipment inspection and testing, and it is subject to on-going surveillance.

2.           Manufacturing

              The manufacturer shall operate an approved quality system for production, final product inspection and testing of the products concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.

§ 190  Manufacturing

The manufacturer has to implement and manage an approved quality system for his operations of production, final product inspection and testing of his products, in order to ensure compliance of the manufactured products to the approved EU-type (under module B) and the legislative requirements.

For the general obligations of manufacturers, see section § 75.

3.           Quality system

3.1.        The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

              The application shall include:

              (a)     the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

              (b)     a written declaration that the same application has not been lodged with any other notified body,

              (c)     all relevant information for the product category envisaged,

              (d)     the documentation concerning the quality system,

              (e)     the technical documentation of the approved type and a copy of the EU-type examination certificate.

3.2.        The quality system shall ensure that the products are in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to them.

              All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

              It shall, in particular, contain an adequate description of:

              (a)     the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

              (b)     the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

              (c)     the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

              (d)     the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and

              (e)     the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

3.3.        The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

              It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

              In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.1(e) to verify the manufacturer's ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

              The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.        The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.        The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

              The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

              It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

§ 191  Quality system

The quality system must include the following elements and has to be documented:

- quality objectives,

- organisational structure,

- manufacturing and quality control techniques,

- tests (carried out before, during and after manufacturing),

- quality records, and

- monitoring methods.

The manufacturer has to fulfil the obligations related to the quality system and must ensures compliance of the manufactured products to the approved EU-type (under module B) and the legislative requirements.

The manufacturer has to submit an application to a notified body to carry out an assessment of his quality system. Application forms prepared by notified bodies can be used.

The notified body performs initial and periodic audits in order to assess and survey the quality system, including:

- review of the technical documentation,

- control of the quality system,

- inspections, and

- product tests.

A quality system implemented on the basis of the standards EN ISO 9000 and EN ISO 9001 gives a presumption of conformity with the respective modules with regard to the provisions in the modules that these standards cover, provided that the quality system takes into consideration the specificities of the concerned products. However, the manufacturer is free to apply other quality system models than those based on EN ISO 9001 for the purpose of complying with these modules.

4.           Surveillance under the responsibility of the notified body

4.1.        The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.        The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

              (a)     the quality system documentation,

              (b)     the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3.        The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4.        In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

§ 192  Surveillance under the responsibility of the notified body

Surveillance under the responsibility of the notified body is limited only to the assessed area. Typically notified bodies specify the list of EU-type examination certificates covered by their surveillance. As a part of such activities, notified bodies must inform relevant bodies in case of critical findings during audits.

5.           CE marking, EU declaration of conformity and attestation of conformity

5.1.        The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

5.2.        The manufacturer shall draw up a written EU declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

              A copy of the EU declaration of conformity shall accompany every product, other than a component.

5.3.        The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

§ 193  CE marking, EU declaration of conformity and attestation of conformity

As in this conformity assessment module (D) the notified body is involved in the production phase, the CE marking must be followed by the identification number of the notified body.

CE marking should not be affixed to a component (see section § 47 on components).

A written declaration of conformity should be issued by the manufacturer (or its authorised representative) except for components. For components a written attestation of conformity must be issued.

6.           The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

              (a)     the documentation referred to in point 3.1,

              (b)     the information relating to the change referred to in point 3.5, as approved,

              (c)     the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

§ 194  Obligations for the manufacturer: retention of documentation - quality assurance

The manufacturer, or where relevant, the authorised representative or importer, shall, for a period ending at least 10 (ten) years after the product has been placed on the market, be able to make available to the national authorities:

  • the documentation of the quality system;
  • updating of the quality system;
  • audit reports and certificates of the notified body.

The provision on "10 years after the product has been placed on the market" should be understood as related to the last item of the product model placed on the market.

Larger organisations have a certified quality management system according to the ISO 9000 standards. For these manufacturers it is recognised that it is difficult to keep all quality documents and all changes to the quality system for such a long period. It is the opinion of the ATEX Committee that the requirements in Annex IV, section 6 of the ATEX Directive 2014/34/EU are fulfilled if the manufacturer keeps at the disposal of the national authorities at least the actual quality management system documents plus the following documents which have to be kept for a period ending at least 10 years after the last piece of equipment was manufactured:

  • audit reports and certificates of the ISO 9000 certifier. This will be one or two audit reports per year that include the actual state at that moment of the quality system with changes;
  • audit reports and notifications of the notified body that issued the notification of quality assurance of the production process.

The above consideration is against the background that this documentation shall always be sufficient so as to enable surveillance authorities to determine that the relevant conformity assessment procedure(s) was/were applied in a satisfactory manner and that the relevant obligations of the Directive were fulfilled.

7.           Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

              Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

§ 195  Obligations for the notified body

Notified bodies are obliged to co-operation and coordination of its activity. In particular, notified bodies have a general obligation to inform national market surveillance authorities and the other notified bodies about the assessments of quality systems they have carried out.

8.           Authorised representative

              The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

§ 196  Authorised representative

According to the mandate contractually agreed with the manufacturer, the authorised representative can be entitled to lodge the application for the assessment of the quality system and to fulfil the obligations related to information, marking, declaration or attestation of conformity, and to retaining the relevant documentation.