Geschäftserfolg ermöglichen

Operation

Wir stellen sicher, dass Ihre Qualitäts-,Gesundheits-, Sicherheits- und Umweltanforderungen (QHSE) erfüllt werden. Wir lösen geschäftliche Herausforderungen für kleine und mittlere Unternehmen in drei Phasen: Unternehmens Auswertung, Implementierung und Operation. Wir konzentrieren uns in jeder Phase darauf, Ihrem Unternehmen einen unmittelbarenMehrwert zu bieten.

Operation

N’Ginie Platform: Einfache, intuitive und integrierte EQMS Desktop und mobile Anwendung.
Die Elemente des Managementsystems werden vom Teamauf natürliche Weise ohne zusätzliche Ressourcen erreicht.
  1. Basic: Wir bieten N'Ginie, unser Tool zur Digitalisierung von Geschäftsprozessen, das Online-Beratung zu Qualität und Compliance enthält. Ihr Unternehmen wird 85% der Anforderungen an das ISO-Managementsystem erfüllen, indem Sie einfachunser Tool verwenden. Wir bieten auch Online-Support in Fragen zu Qualität,Gesundheit und Sicherheit.
  2. Professionelle Ebene: Zusätzlich zu den grundlegenden Qualitäts- und Compliance-Tools, die inder Basisebene angeboten werden, überprüfen unsere Experten mit derprofessionellen Lösung, ob Ihr Unternehmen die geltenden Qualitäts- und Compliance-Anforderungenerfüllt. Wir stellen sicher, dass Ihr Unternehmen die Erwartungen erfüllt, führenIhre internen Audits durch, überprüfen die Überprüfung des Managements undbewerten Ihre Korrekturmaßnahmen.
  3. Premium Level: Wir bieten eine Komplettlösung, die die Verantwortung für den BetriebIhrer Qualitäts-, Gesundheits-, Sicherheits- und Umweltfunktion übernimmt. Wirsind Teil Ihres Unternehmens, indem wir Ihr Team unterstützen, um Complianceund kontinuierliche Qualitätsunterstützung sicherzustellen. Zusätzlich zurLösung auf professioneller Ebene überwachen wir Ihr Unternehmen, entwickelnIhre Managementüberprüfung, verwalten Ihr Korrekturmaßnahmenprogramm understellen Ihre technische Dokumentation, um die Anforderungen des Systems zuerfüllen.

eQMS and Collaboration Platform​

The N’Ginie Platform has the ISO elements embedded in the methods used in Organizational Infrastructure. Collaboration Platform to document company’s processes and structure activities and documentation. Business Dashboard, Project Management, Knowledge Management, Resource Management and Allocation, Documentation and Change Control, Professional development and history.

Quality Online Support​

We support your team with questions related to quality, health, safety and environmental questions and if need with ways to maximize the use of N’Ginie, our online management tool.

Business Risk Management​

We review the context of the organization in relationship to the the organization’s mission, vision and strategic direction. We maintain the company’s SWOT analysis. We keep track of the strategic initiatives supporting the higher impact relevant internal and external business factors for the improvement the company’s business and management systems.

Business Monitoring​

We monitor the performance of the company as required by the business and the international standards. We provide a new set of eyes, we prepare performance measurements, customer satisfaction surveys, business and conduct management reviews.

Internal Audit Program​

We manage your audit program as required for the international standards and to assure your company is performing. We prepared detailed reporting findings to constructively improve the operation and the organization’s compliance to standard and regulatory requirements.

Create Management Review​

We work with the team to compile all required information and company performance to meet the standard requirements for management review in alignment with the business needs. We made this activity a management tool to support the strategic direction and company improvement.

Evaluation of Management Review​

We work side to side with the company’s leadership to evaluate the company’s performance and assess their overall compliance to the quality, health, safety and environmental requirements.

Corrective Action Management​

We execute specific savings and/or risk mitigation projects including the development of new processes due to new business initiatives. Technical, quality and regulatory support the validation and documentation of new products and services.

Evaluation of Corrective Actions​

We drive the corrective action process following disciplined methods for: proper non-conformance identification, root cause analysis, implementation plan and effectiveness review.

Technical Writing​

We maintain any required standard operating procedures, work instructions to keep your company’s processes meeting changing requirements to your team, your customers, country regulations, that are simplified and adapted to the needs and conditions of the organization.

Registration Support​

We assume full responsibility for the registration process with the notifying bodies. We maintain contact, supply information and assure a successful process with the surveillance and recertification audits. We follow up with the required information for the company questions and resolution of any nonconformances.

KERNDIENSTLEISTUNGEN

Unsere Methode

Assessment

Identify your operational opportunities, compliance risks, and a road plan for implementation.

Implementation

Structure your business processes to assure sustainability and growth.

Operation

Resolve your immediate, proactive and reactive quality and compliance needs.​

References

CO2 refrigeration control units, 4 employees, Sønderborg, DK, Recertification, revamp and operation of ISO9001:201 management system

Desinfection water generators, 8 employees, Sønderborg, DK, Implemention of ISO9001:2015 from scratch

Design, Assembly and service of control panels, 65 employees, Esbjerg, Hobro, Ikast, Sønderborg DK, Recertification, revamp and operation of ISO9001:201 management system

Testing Automated Equipment, 12 employees, Sønderborg, DK, Implemention of ISO9001:2015 from scratch

Insulin pump for Diabetes II patients, 8 employees Nordborg, DK, Quality Sytems and validation of production process to ISO13485:2009

HiRel Division – Power semiconductors, 200 employees, Leominster MA USA, Merge quality systems for four sites in compliance to AS9001C

Operating room equipment (Surgical beds, boom and lights), 22 employees, Charleston, SC, USA, Established management system to meet ISO13485:2009

 Aerospace repair station – 6 employees, Commercial aircraft electric generators, Miami FL USA, Reestablished qmanagement system to CFR 141 to regain contract with Air Canada