Innovative Product Market Entry Through Standardization and Conformity Assessment
Discover how standardization and conformity assessment play crucial roles in introducing innovative products to the market. Learn about the accreditation activities of DAkkS in Germany and the process of accreditation in the EU. Explore the significance of ISO standards and the steps involved in accreditation and notification.
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Presentation Transcript
Standardization and conformity assessment as tools for enter of innovative products to the market Dr. Stephan Finke Deutsche Akkreditierungsstelle GmbH 26.04.2017 |
DAkkS in brief DAkkS is Germany s national accreditation body Legal mandate: accreditation of CABs Operational since 1stJanuary 2010 DAkkS is subject to supervision by the Federal Government Delegation of public service tasks by entrustment DAkkS is operating on a non-profit basis 26.04.2017 2 |
Accreditation activities of DAkkS Testing and Calibration Laboratories ISO/IEC 17025 Laboratories Medical Laboratories ISO 15189 Inspection Bodies ISO/IEC 17020 for Persons ISO/IEC 17024 for Management Systems ISO/IEC 17021 Certification Bodies for Products ISO/IEC 17065 (old: EN 45011) Validation and Verification Bodies ISO 14065 Providers of Proficiency Tests ISO/IEC 17043 01/2013 Producers of Reference Materials ISO Guide 34 (17034) 26.04.2017 4 |
Accreditation in the EU performed by NABs appointed by Member States as required by EU Regulation 765/2008 Regulated area: accreditation required by law qualifies certain products/services which can be put onto the market only after undergoing conformity assessment against the applicable standards (notification) Voluntary area: no specific legislation CABs seek accreditation to provide the market with an impartial attestation of their competence 5 26.04.2017 |
Accreditation in the EU performed by NABs appointed by Member States as required by Regulation (EC) 765/2008 Regulated area Voluntary area accreditation required by law qualifies certain products/services which can be put onto the market only after undergoing conformity assessment against the applicable standards (notification) no specific legislation CABs seek accreditation to provide the market with an impartial attestation of their competence 6 26.04.2017 |
Accreditation and notification ISO standards (17000 series) 2. step: notification from national authority CAB offers conformity assassment in this area to the market 1. step: accreditation from DAkkS proof of competence (with regard to technical abilities) legal authorization DE: 208 NBs in total 7 26.04.2017 |
Strengthening of Accreditation Decision No 768/2008/EC (38) ... Since accreditation is an essential means of verifying the competence of conformity assessment bodies, its use should also be encouraged for the purposes of notification. (DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a common framework for the marketing of products) 26.04.2017 8 |
Overview Innovative Technologies IEC 62443 Industrial Automation and Control Systems Security Critical Infrastructures (Energy distribution) Energy Act Code of PLM Openness (CPO) Realizing IoT Trust Services EU Regulation 910/2014 - eIDAS electr. IDentification And trust Service for el. Transactions Financial Services Directive 2014/92/EU General Data Protection Regulation Regulation 2016/679 9 26.04.2017 |
