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| Chapter | /Section | Title |
|---|---|---|
| 1 | 7 | PRODUCT REALIZATION |
| 7.10 | Planning of Product Realization | |
| 7.10 Planning of Product Realization (QMS 7.1) Processes for product development and for the manufacture of products and service activities, including changes of these processes and activities, shall be defined during quality planning under the responsibility of the Process Owner responsible. All planning activities related to manufacturing and or service shall be conducted in close cooperation with Manufacturing or Technical Service, as applicable. The planning for product realization shall be consistent with clause 4.1 of this standard, and shall include as applicable: quality objectives and requirements for the product, as well as manufacturing plans which shall include necessary resources, documents, inspection and acceptance criteria, and records. As required, Process Owners are responsible for the development of additional documents and procedures, and their implementation. | ||
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