Assessment and verification systems (AVS)
ANNEX IXSupplementary provisions
ANNEX IX Assessment and verification systems (AVS) The manufacturer shall, in accordance with Article 22(1), correctly determine the product type and apply the corresponding product category on the basis of the applicable harmonised technical specification or European assessment document. Where a notified body is involved in assessment and verification, the notified body shall, in accordance with Article 55(1), verify that the product type was correctly determined and the corresponding product category was correctly applied. 1. System 1+ Full notified body control including audit sample testing (a) The manufacturer shall carry out: (i) factory production control; (ii) further testing of samples taken at the manufacturing plant in accordance with the prescribed test plan; (iii) the drawing up of technical documentation containing proof of the correct application of this Regulation with regard to the assessment of performance; (iv) the drawing up of technical documentation containing proof of conformity with the applicable product requirements under this Regulation. (b) The notified body shall decide on the issuing, restriction, suspension, or withdrawal of the certificate of constancy of performance and of conformity of the product on the basis of: (i) confirmation that the product type and the product category were correctly determined; (ii) an assessment of the performance of the product on the basis of type-testing (including sampling of the items to be taken as representative of the type), type calculation or tabulated values or documentation describing the product; (iii) initial inspection of the manufacturing plant and of factory production control; (iv) continuing surveillance, assessment and evaluation of factory production control including periodic inspections to the manufacturing plant; (v) audit-testing of samples taken before placing the product on the market; (vi) verification of the tasks under points (a) (iii) and (iv). 2. System 1 Full notified body control without audit sample testing (a) The manufacturer shall carry out: (i) factory production control; (ii) further testing of samples taken at the manufacturing plant by the manufacturer in accordance with the prescribed test plan; (iii) the drawing up of technical documentation containing proof of the correct application of this Regulation with regard to the assessment of performance; (iv) the drawing up of technical documentation containing proof of conformity with the applicable product requirements under this Regulation. (b) The notified body shall decide on the issuing, restriction, suspension, or withdrawal of the certificate of constancy of performance and of conformity of the product on the basis of: (i) confirmation that the product type and the product category were correctly determined; (ii) an assessment of the performance of the product on the basis of type-testing (including sampling of the item or items to be taken as representative of the type), type calculation or tabulated values or documentation describing the product; (iii) initial inspection of the manufacturing plant and of factory production control; (iv) continuing surveillance, assessment and evaluation of factory production control including periodic inspections to the manufacturing plant; (v) verification of the tasks under points (a) (iii) and (iv). 3. System 2+ Notified body focusing on the factory production control (a) The manufacturer shall carry out: (i) an assessment of the performance of the product on the basis of testing (including sampling of the item or items to be taken as representative of the type), type calculation, tabulated values or documentation describing that product; (ii) factory production control; (iii) testing of samples taken at the factory in accordance with the prescribed test plan; (iv) the drawing up of technical documentation containing proof of the correct application of this Regulation with regard to the assessment of performance; (v) the drawing up of technical documentation containing proof of conformity with the applicable product requirements under this Regulation. (b) The notified body shall decide on the issuing, restriction, suspension or withdrawal of the certificate of conformity of the factory production control on the basis of: (i) confirmation that the product type and the product category were correctly determined, and that the performance of the product was correctly assessed on the basis of the review of the documentation of the product; (ii) initial inspection of the manufacturing plant and of factory production control; (iii) continuing surveillance, assessment and evaluation of factory production control, including periodic inspections to the manufacturing plant; (iv) verification of the tasks under points (a) (iv) and (v). 4. System 3+ Notified body’s control of environmental sustainability assessment (a) The manufacturer shall carry out: (i) the assessment of the performance of the product on the basis of data collection for input values, assumptions and modelling; (ii) factory production control. (b) The notified body shall decide on the issuing, restriction, suspension or withdrawal of the validation report on the basis of: (i) validation of the input values, assumptions made and compliance with applicable generic or product category specific rules; (ii) validation of the manufacturer’s assessment; (iii) validation of the process applied to generate that assessment; (iv) validation of the correct usage of software appropriate for the assessment; (v) initial inspection of the manufacturing plant to validate any company-specific data. 5. System 3 Notified body focusing on the determination of the product type (a) The manufacturer shall carry out: (i) further assessment of the performance of the product on the basis of testing (including sampling of the items to be taken as representative of the type), type calculation, tabulated values or documentation describing that product; (ii) factory production control; (iii) the drawing up of technical documentation containing proof of the correct application of this Regulation with regard to the assessment of performance; (iv) the drawing up of technical documentation containing proof of conformity with the applicable product requirements under this Regulation. (b) The notified body shall decide on the issuing, restriction, suspension or withdrawal of the certificate of performance and of conformity of the product on the basis of: (i) an assessment of the performance on the basis of testing performed by a notified testing laboratory (based on sampling carried out by the manufacturer), calculation, tabulated values or documentation describing the product; (ii) confirmation that the product type and the product category were correctly determined. 6. System 4 Manufacturer’s self-verification and self-certification (a) The manufacturer shall carry out: (i) an assessment of the performance of the product on the basis of testing (including sampling of the items to be taken as representative of the type), type calculation, tabulated values or documentation describing that product; (ii) determine the product type and the product category on the basis of type-testing, type-calculation or tabulated values; (iii) factory production control; (iv) the drawing up of technical documentation containing proof of the correct application of this Regulation with regard to the assessment of performance; (v) the drawing up of technical documentation containing proof of conformity with the applicable product requirements under this Regulation. (b) There is no task for the notified body. 7. The following horizontal rules pertaining to some or all of the systems above shall apply: (a) When a system includes an inspection of the manufacturing plant by a notified body, those inspections shall cover all locations at which significant manufacturing processes take place and shall at least include verification of the following elements: (i) the factory production control specifying the measures and frequencies foreseen to ensure constancy of performance, including the critical to performance parameters; (ii) an outline of the intended factory production control. (b) When a system includes factory production control, those controls shall cover the production process from the moment when the raw materials and components were received to the dispatch of the product (‘gate to gate’ approach) once that production has started, and shall at least include the following elements: (i) ensuring that the products conform to the product type and therefore attain the performance declared in the declaration of performance and conformity, and are compliant with the requirements set out in or adopted in accordance with this Regulation; (ii) application of the technical details necessary for the implementation of the assessment and verification system or systems, as defined in harmonised technical specifications, European assessment documents and voluntary harmonised standards, including, as a minimum, those parameters that are critical to performance. (c) When a system includes further testing of samples, the following shall apply: (i) tests shall include testing of an adequate number of products, as defined in harmonised technical specifications, European assessment documents and voluntary harmonised standards, with regard to conformity with the product type; (ii) where tests are not suitable for the product, the product type may be defined using the applicable extended application rules referred in harmonised technical specifications, European assessment documents and voluntary harmonised standards, where available, and notified bodies confirming that the product type was correctly determined shall also confirm that the relevant extended application rules were correctly applied; (iii) results from tests undertaken by another manufacturer or notified body may be used in accordance with Articles 59 and 62. (d) In the case of systems dealing with environmental sustainability, the validation shall consist of the validation of calculations and input data, in which context the notified body shall validate whether the modelling and input data applicable in accordance with the harmonised technical specification or European assessment document reflect the performance of the product, as well as the use of the software provided by the Commission, along with any data used, and in particular shall validate the reliability of any company-specific data used. (e) Notified bodies and manufacturers shall consider the European technical assessment issued for the product as the assessment of the performance of that product. Manufacturers finding evidence or informed by the notified body that the performance of the product is not in conformity with the European technical assessment shall bring that product into conformity with that assessment, including, when relevant, by fulfilling of obligations set out in Article 22(11).