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ISO 13485 vs. ISO 9001 - The documents control requirements |
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What a standard The ISO 13485. It's almost fascinating. We can assure you one thing: it requires a lot of work to get the certification even if you are already certified for the ISO 9001 Standard. The ISO 13485 documents control requirements are tougher, traceability is much more complex and not to mention the training requirements. |
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Digital documents control - The requirements, basics, problem and solutions! |
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Ever happened to you that your employee used the wrong document and caused a mess? Ever happened to you that classified information reach the wrong hands and embarrassed you? Ever happened to you that you lost an important document and knew that your boss would get angry? For no reason? If do, please pay attention! |
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Records control procedure - The ISO 9001 Standard requirements and clarifications |
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In God we trust! all others require a review. In a direct association to the documents control, we will deal now with the records control requirements. The ISO 9001 Standard requires a definition of what records we must preserve as part of our quality system in order to realize our product. |
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Documents control procedure and solutions for the ISO 9001 Standard requirements |
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The job's not over until the paperwork's done. The ISO 9001 standard cares for us. It cares for us from several aspects. One of these aspects regards our documentation. The ISO 9001 Standard requires that we will document our quality management system by all means. |
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