Accreditation is used in both the regulated sector to meet the requirements of certain legislation and the voluntary area where there is no specific legislation.
Accreditation aims to increase trust in conformity attestation and thus reinforces the mutual recognition of products, processes, services, systems, persons and bodies across the EU.
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.
Accreditation in the EU
Regulation 765/2008, which sets out requirements for accreditation and market surveillance relating to the marketing of products, establishes the legal framework for accreditation in Europe.
The Regulation promotes a uniformly rigorous approach to accreditation across Member States – so that ultimately one accreditation certificate will be enough to demonstrate the technical capacity of a conformity assessment body.
The main principles of accreditation in the Regulation (which complement the relevant international standard for accreditation bodies) are:
- One accreditation body per Member State (but it is possible to have recourse to another Member State’s national accreditation body, should a Member State decide not to set up its own).
- Accreditation is a public sector activity.
- There is no competition between national accreditation bodies.
- Accreditation is a not-for-profit activity.
- Stakeholder representation is ensured.
- Accreditation is the preferred means of demonstrating technical capacity in the regulated area – in the appointment of notified bodies.
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).
INAB was established in 1985 and is a Committee of the Health and Safety Authority under the Industrial Development (Dissolution of Forfas) Act 2014.
In January 2010, the European Commission was notified by the Department of Enterprise, Trade and Employment (now the DETI) as being the sole accreditation body for Ireland in line with regulation EC/765/2008.
INAB has identified and analysed its relationship with related bodies within Government for its ranges of activities and within its present structure and concludes that no potential conflict of interest exists.
INAB’s Functions Include:
- Accreditation of Testing and Calibration Laboratories ISO 17025, ISO 15189
- Accreditation of Certification Bodies IS0 17021, IS0 17024, ISO 17065
- Accreditation of Greenhouse Gas Verifiers ISO 14065
- Accreditation of Inspection Bodies ISO 17020
- Accreditation of Reference Material Producers ISO Guide 34
- Accreditation of EMAS Verifiers and National Competent Body for registration of EMAS organisations
- Eco-Management and Audit Scheme (EMAS) – Council Regulation
- National Compliance Monitoring Authority for Good Laboratory Practice SI 1991 No 4 implementing EC Directive 88/320/EEC (GLP)
- Accreditation for the purposes of notification to European Product Directives.