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Resource management 6.1 Provision of resources The manufacturing organization shall determ...

2023-05-25T05:48:06

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

2023-07-04T04:36:51

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General The manufacturer shall establish, document, implement and maintain a quality manag...

2023-05-25T05:04:20

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Management commitment Top management of the manufacturer shall provide evidence of its com...

2023-07-04T04:47:00

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Finished device means any device or accessory to any device that is suitable for use or ca...

2023-06-28T10:42:43

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Product realisation 7.1 Planning of product realization The manufacturer shall plan and de...

2023-05-25T06:42:10

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Control of records: Records shall be established and maintained to provide evidence of con...

2023-05-25T05:10:06

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