Quality System Registration
While the EU legislation focuses on product approval, there are many instances in which the independent assessment of a manufacturer’s design and/or production process is also an important factor in marketing in the EU. Process approval in Europe generally means registration by an independent third party to the relevant standard in the ISO 9000 series (quality management and quality assurance standards). ISO 9000 registration is require in EU markets, both in legal terms and as a competitive factor. Compliance with ISO 9000 standards is referenced in specific EU product safety directives as a component of the product approval process. In a growing number of sectors, European purchasers may require suppliers to attest that they have an approved quality system in place as a condition for purchase. ISO 9000 registration may also be a competitive factor in product areas where safety or liability is a concern.