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ISO 13485 Improvement requirements |
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While the ISO 9001 Standard requires to continually improving the effectiveness of the quality management system with use of elements such as Quality policy, quality objectives, performing audits, data analysis, CAPA and management reviews, his younger cousin, the ISO 13485 Standard, specifically describes how he expects the organization to perform continual improvement… |
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ISO 13485 Corrective Action requirements |
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In this article we will review the additional requirements for corrective actions (chapter 8.5.2 - corrective action) as specified by the ISO 13485 Standard with reference to the ISO 9001 Standard. The corrective action requirements within the ISO 13485 Standard are not so complex. The main differences regard the documentation requirements. |
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ISO 13485 Preventive Action requirements |
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In this article we will review the additional requirements for preventive actions (chapter 8.5.3 - preventive action) as specified by the ISO 13485 Standard with reference to the ISO 9001 Standard. |
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