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As applicable to your company, make use of your organizational knowledge, lessons learned and experience with the QMS to determine the opportunities and risk that need to be addressed and that can: • Give assurance that the procedure can achieve its intended results, • Enhance desirable effects, and prevent or reduce undesired effects, • Achieve improvement. Actions to address the risks and opportunities are planned in order to integrate and implement them into the QMS processes and to evaluate the effectiveness of these actions. Quality objectives at relevant functions, levels and processes are established by the Quality team / ISO steering committee and are based on the objectives of top management. The quality objectives are consistent with the quality policy, are measurable; take into account applicable requirements, are relevant to conformity of products and services and the enhancement of customer satisfaction; The objectives are monitored, communicated, and updated as required. When changes to the QMS are needed, the Quality team leader / ISO management representative ensures that they are carried out in a planned and systematic manner with consideration is given to the purpose of the change and any of its consequences, the integrity of the QMS, the availability of resources, and the assignment of responsibilities.