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The ISO 13485 Standard requires defining which outputs are expected at the end of any development stage. The outputs must be supplied in a manner that would enable to verify them against the requirements of the design and development inputs.ISO 9001
ISO 9001
| ISO 13485
| The output of any milestone must meet the requirements of the next development stage.
| The output of any milestone must meet the requirements of the next development stage.
| The outputs must provide appropriate information for later purchasing, production processes and provision of services.
| The outputs must provide appropriate information for later purchasing and service provision.
| Outputs must include references for the products criteria: accepting or rejecting.
| Outputs must include conclusions for the products criteria: accepting or rejecting.
| The outputs must define accurately the products characteristics to ensure proper use of the product.
| The outputs must generate the products characteristics to ensure the proper use of the product.
| The outputs must be approved before release.
| The outputs must be approved before release.
| | | Records of the design and the development outputs must be maintain and must be submitted to the records control procedure as required in paragraph 4.2.4 – control or records.
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The design and the development outputs shall be defined and documented according to a defined method. In other words, it is required to define which outputs are expected at the end of any design and development stage. The outputs are to be verbally (yes, yes) expressed. How can one express his design and development outputs? As much as it would be a surprise to you, but with product's portfolio, master models, master product, work instructions, process specifications, instructions for assembly or disassembly, installation instructions, operation instructions, training kit. Shall we go on or is it clear enough? The requirements for outputs are to be planned to adjust themselves to the next stage of the developing process. You are developing a product according to a defined plan (paragraph 7.3.1). it is essential that by any development stage, you would generate the required output to the next stage. The ISO (both the ISO 9001 Standard and 13485) requires that. It is much logic. The next requirement of the outputs is to provide the appropriate information of the product's characteristics in order to: - Purchase the right "ingredients", so you may realize the product as designed
- To plan the right activities in order to realize the product
- To design the appropriate activities after the organization has delivered the product (the service part of the product).
The only additional requirement for design and development refer to maintaining records of the outputs. The ISO 13485 Standard requires that any output of the design and the development would be documented. Documenting the outputs may occur as the product prototype, a routing chart indicating the development stages, a documentation of changes and events throughout the development processes, as mentioned above. You are required to define the design and the development outputs as part of the quality records list. |
