Competencies & Service Portfolio
Behind every successful market entry lies a robust foundation of documentation, liability management, and process quality. Systemic Standards provides you with the necessary expertise to not only meet regulatory requirements but also to efficiently integrate them into your business operations.
I. Strategic Market Representation (EU Economic Actor)
Taking on the role of the responsible person is much more than just providing an address. We act as your legal anchor point within the European Union and serve as the shield for your distribution.
Authorization as a Representative & Responsible Person:
We take on full legal representation in accordance with the Market Surveillance Regulation (EU) 2019/1020 and the new Product Safety Regulation (GPSR) 2023/988. This ensures that there is always an accessible contact person for your products for European regulatory authorities—a mandatory requirement for lawful trade.Active Authority Management & Customs Support:
We facilitate all communication with market surveillance authorities and customs. In case of inquiries regarding compliance or labeling, we act as your professional intermediary to clear up any misunderstandings and to proactively prevent goods seizures or distribution stoppages.Risk and Incident Management:
In the event of safety notifications, accidents, or consumer complaints, we coordinate the necessary reporting chain. We assist you in assessing risks and implementing necessary corrective measures, including support during recall actions (Recall Management).Legally Compliant Archiving:
Legislators require a 10-year retention of technical documents after the last product has been placed on the market. We ensure this archiving on highly secure, GDPR-compliant EU servers, so you remain accountable even years later.II. Product Compliance & Technical Engineering
A product is only market-ready when its safety is documented with evidence. We accompany you through the entire compliance assessment process.
What is CE? (Conformity for Specific Sectors)
The CE marking is not a quality seal but a legally required "passport" symbol for the European internal market. It documents that a product meets the specific requirements of relevant EU directives (e.g., for machinery, toys, or electronics).Our Services:
We identify the relevant directives for you (EMC, RoHS, Low Voltage, Machinery Directive, etc.) and carry out the necessary testing steps to achieve certification readiness.What is GPSR? (General Product Safety)
The General Product Safety Regulation (EU) 2023/988 acts as a safety net for almost all consumer products. It requires comprehensive traceability, risk analyses, and the appointment of a responsible person in the EU—even for products that do not carry the CE marking.Our Services:
We implement the GPSR requirements into your supply chain, check labeling obligations, and prepare the required safety analyses.Auditing & Gap Analysis:
In-depth review of your existing test reports and risk analyses for compliance with harmonized standards. We identify gaps before authorities do.Creation of technical documentation: Support in drafting precise EU declarations of conformity and technical documentation according to Annex VII/VIII of the respective regulations.
III. Management Systems & Operational Excellence (ISO)
Sustainable compliance starts within the company. We optimize your management systems so that quality and safety become an automated part of your value creation chain.
What is ISO? (International Process Standards)
ISO standards (such as ISO 9001 for quality or ISO 14001 for environment) define internationally recognized requirements for management systems. They ensure reproducible quality, risk minimization, and continuous improvement.ISO 9001 (Quality Management):
We structure your processes to minimize sources of error and prepare your organization for certification by a “Notified Body.”ISO 14001 (Environmental Management):
We assist you in implementing sustainable processes to efficiently combine ecological responsibility and regulatory requirements.Preparation for External Certifications:
We conduct internal audits, identify optimization potentials, and actively accompany you until successful audits by external certification bodies (TÜV, DEKRA, etc.).Training & Awareness:
We train your teams on compliance regulations to permanently reduce the risk of instructional and liability errors in daily practice.Your Benefit from Systemic Standards
We combine precise knowledge of ISO process structures with the operational and legal responsibility of EU representation.The result is a comprehensive compliance concept from a single source: We reduce your liability both internally and externally, accelerate your market access, and make adherence to complex EU laws a manageable success factor for your company.
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