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In focus - Innovation Policy

Conformity Assessment and Accreditation

Introduction

Germany is one of the most successful exporters in the world. The "Made in Germany" label is known right around the globe as a mark of entrepreneurial spirit and excellent quality. The core objective of German economic and technology policy is to sustain and modernise Germany's infrastructure so that it allows this high level of quality to be maintained and built upon. A reliable quality infrastructure not only includes standardisation and statutory metrology, but also conformity assessment (testing and certification of compliance with specified requirements for products and services) and accreditation (providing written proof of the technical expertise of conformity assessment bodies by an independent body).

Much of the legal framework, e. g. the technical harmonisation of the internal market, and many of the institutions dealing with quality infrastructure are decided upon at EU level, and by international bodies, e. g. under the Agreement on Technical Barriers to Trade (TBT) administered by the World Trade Organisation (WTO).

Conformity: Compliance of products with specified requirements

Consumers encounter products bearing certification marks, such as the CE mark or the GS mark, on a daily basis. These can be found on a wide of goods, including toys, electrical appliances, medical products, and lifts. They certify that a product complies with specified requirements - the CE mark indicating compliance with EU requirements and the GS mark compliance with the requirements set out in the German Equipment and Product Safety Act.

The term 'conformity' is used to describe the situation whereby a service, process, system, person, or unit fulfils a series of requirements that are stipulated by law, in a contract, or otherwise.

Legal requirements mostly apply in areas where government has a particular duty to protect the public, i. e. consumer and environmental protection, healthcare, and occupational health-and-safety. Private-sector firms, in turn, seek to provide proof that their product or service meets specific quality standards and look to demonstrate their own expertise in a particular area.

Within conformity assessment, it is not just specific requirements that can be stipulated by law, in a contract, or adhered to voluntarily, but also the conformity assessment itself. Conformity assessment involves such tasks as calibration, certification, inspection, and testing (e. g. tests on drinking water to check that it is free from any harmful substances). Such assessments can be conducted by the manufacturer or provider himself, by contractual partners, or by independent third-party test and calibration laboratories / inspection and certification bodies.

Conformity assessment conducted by private or public-sector bodies

Conformity assessment bodies can be private or run by the government. Well-known private conformity assessment bodies in Germany include the Technische Überwachungsvereine (TÜV), the Deutsche Kraftfahrzeug-Überwachungsverein (DEKRA), and the ship classification society Germanischer Lloyd, which also undertake a great deal of testing and monitoring on behalf of the German government. However, the government also has the means to perform high-level conformity assessment itself, for example through the science and technology institutes governed by the Federal Ministry for Economic Affairs and Energy. Examples of these include the German National Metrology Institute (PTB), which conducts conformity assessment activities in the field of statutory metrology (e. g. EC type examinations on energy measurement equipment), and the Federal Institute for Materials Research and Testing (BAM), which undertakes conformity assessment activities in areas relevant to technical safety, including dangerous-goods containers (e. g. CASTOR containers), and explosive materials.

Conformity assessments such as test reports, certificates, or declarations of conformity issued by the manufacturer are often required for a contract to be signed or before a product can be released onto the market.

Testing the assessment bodies

Accreditation provides a means to test and assess the level of expertise of conformity assessment bodies. In order to become accredited, a conformity assessment body needs confirmation from a third party that it possesses the specialist expertise to carry out specific conformity assessment activities.

Since the entry into force of EU Regulation 765/2008 (PDF, 160 KB), the accreditation of conformity assessment bodies is a sovereign task to be conducted by a single national accreditation agency in the respective member state. In Germany, this is the Deutsche Akkreditierungsstelle GmbH (DAkkS).

Accreditation enables comparability and creates trust

Accreditation makes it possible to compare conformity assessment certificates and to establish confidence in these assessments among businesses and within the public administration. It is the foundation upon which the consumer is able to reliably establish the quality of a given product or service. Accreditation precludes the need for expensive duplicate testing by enabling certificates and test reports to be mutually recognised. In this way, accreditation plays a part in reducing technical barriers to trade, thereby facilitating trade.

Accreditation may be required by law for conformity assessment bodies operating in sensitive areas, such as consumer protection, healthcare, occupational health-and-safety, and environmental protection. Where this is not the case (voluntary, non-regulated area), conformity assessment bodies use accreditation as a means to demonstrate to the market and to the customer that they possess the necessary expertise to conduct their activities.

Mutual assessment ("assessment among equals") ensures that the national accreditation bodies in Europe have the necessary level of expertise. The relevant tests are conducted by the European Cooperation for Accreditation (EA).