Regulation (EU) 2016/424 of the European Parliament and of the CouncilShow full title

ANNEX VII CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE H 1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

1. Conformity based on full quality assurance plus design examination is the 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 subsystems or safety components concerned satisfy the requirements of this Regulation that apply to them.

2. Manufacturing

The manufacturer shall operate an approved quality system for the design, manufacture and final inspection and testing of subsystems or safety components as specified in point 3 and shall be subject to surveillance as specified in point 4. The adequacy of the technical design of the subsystems or safety components shall have been examined in accordance with point 3.6.

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 subsystems or safety components 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)

all necessary information on the subsystems or safety components to be manufactured;

(c)

the technical documentation in accordance with Annex VIII for one representative type of each category of subsystem or safety component to be manufactured;

(d)

the documentation concerning the quality system;

(e)

the address of the premises where the subsystems or safety components are designed, manufactured, inspected and tested;

(f)

a written declaration that the same application has not been lodged with any other notified body.

3.2. The quality system shall ensure compliance of the subsystems or the safety components with the requirements of this Regulation 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 the design and product quality;

(b)

the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means, including other relevant technical specifications, that will be used to ensure that the essential requirements of this Regulation will be met;

(c)

the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystems or the safety components;

(d)

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

(e)

the examinations and tests to be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(f)

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

(g)

the means of monitoring the achievement of the required design and 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.

The audit shall include an assessment visit to the premises where the subsystems or the safety components are designed, manufactured, inspected and tested.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the field of cableway installations and in the technology of the subsystems or safety components concerned, and knowledge of the applicable requirements of this Regulation.

The auditing team shall review the technical documentation referred to in point 3.1 to verify the manufacturer's ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or the safety components with those requirements.

The notified body shall notify its decision to the manufacturer or his authorised representative. 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 or the authorised representative of its decision. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

3.6. Design examination

3.6.1. The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.1.

3.6.2. The application shall make it possible to understand the design, manufacture and operation of the subsystem or safety component, and to assess the conformity with the requirements of this Regulation that apply to it.

It shall include:

(a)

the name and address of the manufacturer;

(b)

a written declaration that the same application has not been lodged with any other notified body;

(c)

the technical documentation as described in Annex VIII.

3.6.3. The notified body shall examine the application and, where the design meets the requirements of this Regulation that apply to the subsystem or safety component, it shall issue an EU design examination certificate to the manufacturer. That certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. That certificate may have one or more annexes attached.

That certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems or safety components with the examined design to be evaluated and to allow for in-service control, where applicable.

Where the design does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

3.6.4. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval from the notified body that issued the EU design examination certificate in the form of an addition to the original EU design examination certificate.

3.6.5. Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the EU design examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EU design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.

3.6.6. The manufacturer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 30 years after the subsystem or safety component has been placed on the market.

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 design, 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 provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;

(c)

the quality records as provided for by the manufacturing part of the quality system, 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. The frequency of periodic audits shall be such that a full reassessment is carried out every three years.

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 check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

5. CE marking and EU declaration 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 subsystem or safety component that satisfies the applicable requirements of this Regulation.

5.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component model and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or the safety component model for which it has been drawn up and shall refer to the number of the EU design examination certificate.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. The manufacturer shall, for a period of 30 years after the subsystem or safety component has been placed on the market, keep at the disposal of the national authorities:

(a)

the technical documentation referred to in point 3.1(c);

(b)

the documentation concerning the quality system referred to in point 3.1(d);

(c)

the information relating to the change referred to in point 3.5 as approved;

(d)

the decisions and reports of the notified body referred to in points 3.3, 3.5, 4.3 and 4.4.

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 or withdrawn and, upon request, of quality system approvals which it has issued.

On request, the notified body shall provide the Commission and the Member States with a copy of the quality system approval decision(s) issued.

The notified body shall keep a copy of the quality system approval decision(s) issued, its annexes and additions, as well as the technical file, for a period of 30 years from the date of their issue.

8. Authorised representative

The manufacturer's obligations set out in points 3.1, 3.6.4, 3.6.6, 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.