ANNEX V — Management system for assessing conformity
(referred to in Article 8(2))
- This Annex describes the procedure whereby the manufacturer who satisfies the obligations of point 2 ensures and declares that the product satisfies the requirements of the applicable implementing measure. The EC declaration of conformity may cover one or more products and must be kept by the manufacturer.
- A management system may be used for the conformity assessment of a product provided that the manufacturer implements the environmental elements specified in point 3.
- Environmental elements of the management systemThis point specifies the elements of a management system and the procedures by which the manufacturer can demonstrate that the product complies with the requirements of the applicable implementing measure. 3.1. The environmental product performance policy The manufacturer must be able to demonstrate conformity with the requirements of the applicable implementing measure. The manufacturer must also be able to provide a framework for setting and reviewing environmental product performance objectives and indicators with a view to improving the overall environmental product performance. All the measures adopted by the manufacturer to improve the overall environmental performance of, and to establish the ecological profile of, a product, if required by the implementing measure, through design and manufacturing, must be documented in a systematic and orderly manner in the form of written procedures and instructions. These procedures and instructions must contain, in particular, an adequate description of: (a) the list of documents that must be prepared to demonstrate the product’s conformity, and, if relevant, that have to be made available; (b) the environmental product performance objectives and indicators and the organisational structure, responsibilities, powers of the management and the allocation of resources with regard to their implementation and maintenance; (c) the checks and tests to be carried out after manufacture to verify product performance against environmental performance indicators; (d) the procedures for controlling the required documentation and ensuring that it is kept up-to-date; and (e) the method of verifying the implementation and effectiveness of the environmental elements of the management system. 3.2. Planning The manufacturer must establish and maintain: (a) procedures for establishing the ecological profile of the product; (b) environmental product performance objectives and indicators, which consider technological options, taking into account technical and economic requirements; and (c) a programme for achieving these objectives. 3.3. Implementation and documentation 3.3.1. The documentation concerning the management system must, in particular, comply with the following: (a) responsibilities and authorities must be defined and documented in order to ensure effective environmental product performance and reporting on its operation for review and improvement; (b) documents must be established indicating the design control and verification techniques implemented and processes and systematic measures used when designing the product; and (c) the manufacturer must establish and maintain information to describe the core environmental elements of the management system and the procedures for controlling all documents required. 3.3.2. The documentation concerning the product must contain, in particular: (a) a general description of the product and of its intended use; (b) the results of relevant environmental assessment studies carried out by the manufacturer, and/or references to environmental assessment literature or case studies, which are used by the manufacturer in evaluating, documenting and determining product design solutions; (c) the ecological profile, where required by the implementing measure; (d) documents describing the results of measurements on the ecodesign requirements carried out including details of the conformity of these measurements as compared with the ecodesign requirements set out in the applicable implementing measure; (e) the manufacturer must establish specifications indicating, in particular, standards which have been applied; where standards referred to in Article 10 are not applied or where they do not cover entirely the requirements of the relevant implementing measure, the means used to ensure compliance; and (f) copy of the information concerning the environmental design aspects of the product provided in accordance with the requirements specified in Annex I, Part 2. 3.4. Checking and corrective action 3.4.1. The manufacturer must: (a) take all measures necessary to ensure that the product is manufactured in compliance with its design specification and with the requirements of the implementing measure which applies to it; (b) establish and maintain procedures to investigate and respond to non-conformity, and implement changes in the documented procedures resulting from corrective action; and (c) carry out at least every three years a full internal audit of the management system with regard to its environmental elements.