Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels

ANNEX IV

Module C: Conformity to type 1. This module describes that part of the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the appliances concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of this Directive that apply to them. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each appliance and draw up a written declaration of conformity. 2. The manufacturer must take all measures necessary to ensure that the manufacturing process assures the conformity of the manufactured appliances with the type as described in the EC type-examination certificate and with the efficiency requirements of the Directive. 3. The manufacturer or his authorized representative must keep a copy of the declaration of conformity for a period of at least 10 years after the last date of manufacture of the product concerned. Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the Community market. 4. A notified body chosen by the manufacturer must perform or have performed examinations of the product at random intervals. A suitable sample of the finished products, taken on the spot by the notified body, is examined and appropriate tests, defined in the applicable standard or standards referred to in Article 5 (2) or equivalent tests are carried out to check the conformity of the product with the requirements of the corresponding Directive. In the event of one or more samples of the products examined not conforming, the notified body must take the appropriate measures. Module D: Production quality assurance 1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the appliances concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of this Directive. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each appliance and draw up a written declaration of conformity. The CE marking is accompanied by the identification number of the notified body responsible for the checks referred to in section 4. 2. The manufacturer must operate an approved quality system for production, final appliance inspection and testing as specified in section 3. He is subject to the checks referred to in section 4. 3. Quality system 3.1. The manufacturer lodges an application for assessment of his quality system with a notified body of his choice, for the appliances concerned. The application must include: — all relevant information for the appliance category envisaged, — the documents concerning the quality system, — the technical documents pertaining to the approved type and a copy of the EC type-examination certificate. 3.2. The quality system must ensure conformity of appliances with the type as described in the EC type-examination certificate and with the requirements of this Directive that apply to them. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documents must permit a consistent interpretation of the quality programmes, plans, manuals and quality records. It must contain in particular an adequate description of: — the quality objectives and the organizational structure, responsibilities and powers of the management with regard to appliance quality, — the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, — the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, — the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc., — the means of monitoring the achievement of the required appliance quality and the effective operation of the quality system. 3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in section 3.2. It must presume conformity with those requirements in respect of quality systems that implement the relevant harmonized standard. The auditing team must have at least one member with experience of assessing the relevant product technology. The assessment procedure includes an inspection visit to the manufacturer's premises. The decision is notified to the manufacturer. The notification must contain the conclusions of the examination and the duly substantiated assessment decision. 3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level. The manufacturer or his authorized representative must keep the notified body that has approved the quality system informed of any proposed change in the quality system. The notified body must assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether reassessment is required. It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the substantiated assessment decision. 4. Monitoring under the responsibility of the notified body 4.1. The purpose of monitoring is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer must allow the notified body access for inspection purposes to the manufacturing, inspection, testing and storage premises and provide it with all necessary information, in particular: — the quality system documents, — the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.. 4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and provides an audit report to the manufacturer. 4.4. Additionally the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report. 5. The manufacturer must, for a period of at least 10 years after the last date of manufacture of the product, keep at the disposal of the national authorities: — the document referred to in the second indent of 3.1, — the updating referred to in the second paragraph of 3.4, — the decisions and reports from the notified body which are referred to in the final paragraph of 3.4, and in 4.3 and 4.4. 6. Each notified body must give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn. Module E: Product quality assurance 1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the boilers and appliances are in conformity with the type as described in the EC type-examination certificate. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each boiler and appliance and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for the checks referred to in section 4. 2. The manufacturer must operate an approved quality system for final boiler and appliance inspection and testing as specified in section 3. He must be subject to the checks referred to in section 4. 3. Quality system 3.1. The manufacturer lodges an application with a notified body of this choice for the assessment of the quality system for his boilers and appliances. The application must include: — all relevant information for the boiler or appliance category envisaged, — the quality system's documentation, — the technical documents pertaining to the approved type and a copy of the EC type-examination certificate. 3.2. Under the quality system, each boiler or appliance is examined and appropriate tests as defined in the relevant standard(s) referred to in Article 5 or equivalent tests are carried out in order to verify its conformity with the relevant requirements of the Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must enable the quality programmes, plans, manuals and records to be interpreted in a uniform manner. It must in particular contain an adequate description of: — the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality, — the examination and tests that will be carried out after manufacture, — the means of monitoring the effective operation of the quality system, — quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. 3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. It must presume conformity with these requirements in respect of quality systems that implement the relevant harmonized standard. The auditing team must have at least one member with experience of assessing the relevant product technology. The assessment procedure must include an inspection visit to the manufacturer's premises. The manufacturer must be notified of the decision. The notification must contain the conclusions of the examination and the substantiated assessment decision. 3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level. The manufacturer or his authorized representative must keep the notified body which has approved the quality system informed of any proposed change in the quality system. The notified body must assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required. It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the substantiated assessment decision. 4. Monitoring under the responsibility of the notified body 4.1. The purpose of monitoring is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer must allow the notified body access for inspection purposes to the inspection, testing and storage premises and provide it with all necessary information, in particular: — the quality system documentation, — the technical documents, — the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. 4.3. The notified body must periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer. 4.4. Additionally, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified body must provide the manufacturer with a visit report and, if a test has been carried out, with a test report. 5. The manufacturer must, for a period of at least 10 years after the last date of manufacture of the boiler or appliance, keep at the disposal of the national authorities: — the documents referred to in the third indent of 3.1, — the changes referred to in the second paragraph of 3.4, — the decisions and reports from the notified body which are referred to in the final paragraph of 3.4, and in 4.3 and 4.4. 6. Each notified body must forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.