2 resultados para Compliant cannula
em Doria (National Library of Finland DSpace Services) - National Library of Finland, Finland
Resumo:
This Master’s thesis examines the implementation of management system standard requirements as integrated in the organization. The aim is to determine how requirements from management system standards ISO 14001:2015 and ISO 9001:2015 can be integrated and implemented into the existing ISO 9001:2008 compliant management system. Research was executed as action research by utilizing an operating model about the integrated use of management system standards created by the International Organization for Standardization. Phases of the operating model were applied to the target organization. The similarity and integration potential of relevant standards were assessed by using comparative matrices. Allocation of the requirements and conformity assessment of the processes was executed by gap analysis. The main results indicate that the requirements of the relevant standards are principally equivalent or have the same kind of purpose. The results also show the most important processes of the target organization in terms of requirement compliance, as well as the requirements which affect the process the most. Prioritizing the compliance achievement of the most important processes and implementation of those requirements that have the most effect create an opportunity for organizations to implement the integrated requirements effectively.
Resumo:
When a dominant undertaking holding a standard-essential patent uses its exclusive right to the IP to seek injunctions against those wishing to produce either de jure or de facto standard compliant products, it creates a conflict between the exclusive right to the use of the IP on the one hand and the possible abuse of dominance due to the exclusionary conduct on the other. The aim of the thesis is to focus on the issues concerning abuse of dominance in violation of Article 102 TFEU when the holder of the standard-essential patent seeks an injunction against a would-be licensee. The thesis is mainly based on the most recent ECJ case law in Huawei and the Commission’s recent decisions in Samsung and Motorola. The case law in Europe prior to those decisions was mainly focused on the German case law from Orange Book Standard which provided IP holders great leverage due to the almost automatic granting of injunctions against infringers. The ECJ in Huawei set out the requirements for when a de jure standard-essential patent holder would not be violating Article 102 TFEU when seeking an injunction, requiring that negotiations in good faith must take place prior to the seeking of the injunction and that all offers must comply with FRAND terms, thus limiting the scope of case law derived from Orange Book Standard in Germany. The ECJ chose not to follow all of the reasoning the Commission had laid out in Samsung and Motorola which provided a more licensee-friendly approach on the matter, but rather chose a compromise between the IP holder friendly German case law and the Commission’s decisions. However, the ECJ did not disclose how FRAND terms themselves should be interpreted, but rather left it for the national courts to decide. Furthermore, the thesis strongly argues that Huawei did not change the fact that only vertically integrated IP holders who have made a FRAND declaration are subject to the terms laid out in Huawei, thus leaving non-practicing entities such as patent trolls and entities that have not made a FRAND declaration outside its scope. The resulting conclusion from the thesis is that while the ECJ in Huawei presented new exceptional circumstances for when an IP holder could be abusing its dominant position when it seeks an injunction, it still left many more questions answered, such as the meaning of FRAND and whether deception in giving a FRAND declaration is prohibited under Article 102 TFEU or not.