ISO 13485 Standrad Resource Management requirement
ISO 13485 Standard - Provision of Resources E-mail

The organization must determine and provide the resources needed to implement a quality management system, to maintain its effectiveness continually, and to meet customers' requirements as well as regulatory requirement.

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ISO 13485 Human Resources Requirements E-mail

The importance of training as part of a quality management system

ISO 13485 trainings requirements
The employees are the ones who produce the medical devices. The employees are the ones who are sitting in front of the machines, in front of the computers, in front of your customers, or assembling the products in the manufacturing halls. Industries and services today are becoming more and more different than before. The products and services supplied to customers are more complex. The organization must combine the two together: the human resources and the knowledge. The purpose of the training is to give your employee the opportunity to perform his job like it is planned.

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ISO 13485 Infrastructures requirements E-mail

Like we said before in our recent articles: the ISO organization doesn't like to leave anything open for any debate! Every aspect is taken care of. The ISO 13485 Standard requires that the organization shall manage its infrastructures, resources and the working environment which are directly related to the realization process and the medical device.

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ISO 13485 Work Environment requirements E-mail
ISO 13485 Work environment

The ISO 13485 Standard requires that the organization will manage its infrastructures, resources and the working environment which are related to the realization process and the product. Like we said before in our recent articles: the ISO organization doesn't like to leave anything open for any questions!


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