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7.5.2 The manufacturer shall validate any processes for production and service provision w...

2023-10-19T07:17:46

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The manufacturer shall establish arrangements for these processes including, as applicable...

2023-10-17T05:36:04

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If the product is cleaned in accordance with clause (a) or clause (b) above, the requireme...

2023-10-17T05:28:57

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7.4 Purchasing 7.4.1 Purchasing process: The manufacturer organisation shall establish doc...

2023-10-13T05:24:17

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7.3.3 Design and development outputs: The outputs of design and development shall be provi...

2023-10-13T05:19:00

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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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4.2.2 Quality manual: The manufacturer shall establish and maintain a quality manual that ...

2023-10-10T04:30:57

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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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