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6.0 Resource management 6.1 Provision of resources The manufacturing organization shall de...

2023-10-11T04:45:03

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Review output: The output from the management review shall include any decisions and actio...

2023-07-04T06:57:31

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(e) all personnel shall bear clean body covering appropriate to their duties. Smoking, eat...

2023-10-11T04:55:18

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5.0 Management responsibility 5.1 Management commitment Top management of the manufacturer...

2023-10-10T04:35:45

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These processes shall be managed by the manufacturer in accordance with the requirements o...

2023-10-10T04:27:15

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4. Quality management system 4.1 General The manufacturer shall establish, document, imple...

2023-10-10T04:26:41

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3.18.2 Design validation means establishing by objective evidence that device specificatio...

2023-10-09T05:45:47

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3.13 Quality audit means a systematic, independent examination of a manufacturer's quality...

2023-10-09T05:43:46

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Planning of product realization The manufacturer shall plan and develop the processes need...

2023-07-05T05:15:38

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