EU Regulation (EC No 765/2008) sets out requirements for accreditation and market surveillance relating to the marketing of products. The Regulation lays down common rules for accrediting bodies that ensure that non-food products in the European Union (EU) conform to certain requirements. There are separate regulations in relation to food safety.
The Regulation establishes a surveillance system to guarantee a high level of safety of those products and in general their compliance with applicable requirements. It also sets rules in regard to controls on imports from outside the EU. It establishes the general principles for CE marking.
National Accreditation Bodies
EU countries must:
- appoint a single not-for-profit national accreditation organisation;
- ensure the organisation has sufficient finance and staff to carry out its duties;
- monitor the organisation to ensure it fulfils the requirements given;
- communicate the relevant details to the European Commission which draws up a publicly available list of the various national organisations.
National accreditation bodies must:
- determine whether individual conformity assessment organisations are competent to do their work and monitor their performance;
- restrict, suspend or withdraw accreditation certificates for assessment organisations that become unable to carry out their duties;
- be objective and impartial with efficient management and appropriate internal controls in place;
- agree to peer evaluation;
- inform other national accreditation bodies of their conformity assessment activities;
- make available information on their work to the public on a regular basis.
The European co-operation for Accreditation (EA) manages the peer evaluations to ensure the quality of the services the national accreditation bodies provide.
CE marking may only be attached to a product by a manufacturer, or someone mandated to operate on their behalf, provided it satisfies all the conformity standards. CE marking is used to indicate that the item meets EU legal conformity standards.
The CE marking is a conformity marking consisting of the letters “CE”. CE is an abbreviation for ‘Conformité Européenne’, French for ‘European Conformity’. CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the European technical regulations (“Directives”), related to European health, safety and environmental protection legislation, and that the product compliance has been established using the appropriate conformity assessment procedure(s).
CE marking is obligatory for any product covered by one or more of the European technical regulations requiring the affixing of the CE marking. Without the CE marking, these products are not allowed to be placed or to be put into service in Europe. In this regard, the CE marking sometimes is called a ‘trade passport’: like carrying a passport when entering a country, the CE Marking is required for market access.
Irish National Accreditation Board
The Irish National Accreditation Board is a committee of the Health and Safety Authority. It is the national accreditation body for the purposes of the Accreditation Regulation. The Accreditation Board is independent in the performance of its functions.
The Irish National Accreditation Board (INAB) is the national body with responsibility for the accreditation of laboratories, certification bodies and inspection bodies. It provides accreditation in accordance with the relevant International Organisation for Standardisation ISO 17000 series of standards and guides.
It is the statutory body responsible for Good Laboratory Practice (GLP) and is the competent body for EMAS (European Eco-Management and Audit Scheme).
Accreditation of conformity assessment bodies is based on harmonised standards, which define competence criteria for the national accreditation body and for each category of conformity assessment body (such as laboratories or certification bodies), sector specific requirements and guidance documents drawn up by regional and international organisations of accreditation bodies.
INAB’s Functions Include:
- the accreditation of Testing and Calibration Laboratories ISO 17025, ISO 15189
- the accreditation of Certification Bodies IS0 17021, IS0 17024, ISO 17065
- the accreditation of Greenhouse Gas Verifiers ISO 14065
- the accreditation of Inspection Bodies ISO 17020
- the accreditation of Reference Material Producers ISO Guide 34
- the accreditation of EMAS Verifiers and National Competent Body for registration of EMAS organisations under the Eco-Management and Audit Scheme (EMAS) – Council Regulation
- National Compliance Monitoring Authority for Good Laboratory Practice
- accreditation for the purposes of notification to European Product Directives.
The Authority must establish an Appeals Board and appoint 3 people to the Appeals Board. The Authority shall appoint a chairperson of the Appeals Board from among the members of the Board, and that chairperson shall regulate the procedure of the Board.
A conformity assessment body may make an appeal to the Appeals Board in respect of a decision of the Accreditation Board in respect of accreditation in relation to the body, or a failure by the Accreditation Board to make a decision in respect of accreditation in relation to the body.
The Appeals Board shall determine an appeal within 90 days from the making of an appeal affirming or) quashing the decision of the Accreditation Board and directing the Accreditation Board, for stated reasons, to reconsider its decision.