ISO 13485 Standard Production & service Provision
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The organization is required to plan and perform production and service provision under controlled conditions. The control must be performed and achieved according to the planning requirements specified within clause 7.1 (Planning of Product Realization). The control would apply to all realization processes, and would include activities such as:
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ISO 13485 Standard - 7.5.3 Identification and Traceability E-mail

7.5.3.1 Identification

The ISO 13485 standard separates the issue and implementation of activities and means of distinction, management, and control of the medical device into three main topics: identification, traceability, and status, describing specific requirements for each. In the spirit of the standard we will discuss each in specific detail. Identification is a serious issue that does not receive enough attention throughout our daily productive lives. I have often encountered items and products in production and storage halls where it was difficult to tell what their status was, when were they were produced, and to whom they belonged. This meant that I needed to conduct investigations and interrogations, and to trouble many people in order to receive the desired answers. Fortunately the ISO 13485 standard demands the exact definition and documentation of the all activities and elements related to identification.

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