Resource Management

The provision of resources applies to the allocation of adequate resources necessary for the risk management activities. The main objective is to ensure that appropriate resources will be allocated for the effectiveness of processes and activities related to the risk management:

• Employees with appropriate qualications • Responsibilities and authorities for the activities • Tool and equipment

The rst step in establishing an effective training and certication process is the identi-cation and location of the training needs. The training and the certication of employees in a work place are a process with the purpose of assisting the members of the organization in fullling their activities and tasks better and more effectively by introducing them to skills, knowledge, and professional and organizational approaches. Training and certications may be needed in the following cases:

• Hiring and introducing new personnel • Improvement of knowledge and skills • Introduction of innovations in the organization • Supporting organizational processes

By initiating actions the organization promotes its personnel in achieving work objectives. The qualications, skills, and knowledge required for the fulllment of the product objectives need to be dened and determined according to the characters of the medical device and the nature of the activities:

• Customer requirements • The characters and features of the medical devices • The raw materials or components it is made of • The processes that operate the medical device and constitute its functionality • The processes that realize the medical device

In the organization, in each organizational structure (production, logistics, development, purchase, marketing), different workers perform different tasks and activities that promote one shared goal: realization of the medical device. For each level in each organizational structure it is necessary to dene the level of qualications and skills that the worker needs to perform their tasks. Usually the issue is managed by the function responsible for human resources. But as far as the ISO 13485 Standard is concerned, some elements and job characteristics must be dened and documented:

• Education: The level of knowledge and education required for a role will be determined: engineer, technician, programmer, biologist, certied logistician. Some roles may not require an education or external certication at all. These denitions will be the preconditions for the hiring of personnel for specic roles.