Design and development controls, outputs, and changes (ISO 9001:2015 clause 8.3)
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Design and development controls, outputs, and changes (ISO 9001:2015 clause 8.3)

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Design and development controls, outputs, and changes (ISO 9001:2015 clause 8.3) 


- Design and development control.

To ensure that design and development process will deliver intended results, certain controls must be implemented at some phases of design and development process. These controls include regular reviews to evaluate the results of design and development and determine whether they need inputs requirements.

For example, at end of each phase of design project, the manager, or some other member of design development team that responsible for the phase, can do a review to determine whether the result of the phase meets the requirements.

Beside review, validation and verification activities must be conducted at some phases of design and development to determine whether the outputs meet inputs requirements. If there is a problem during the design and development, activities should be taken to resolve those problems and the records of the activities should be retained. 

- Design and development outputs.

The 2nd section from clause 8.3 from ISO 9001:2015 required the following criteria that design, and development outputs must meet:

- The outputs must be adequate for the subsequent process for the provision of product and services.

For example, the design team may send to production department the drawings in file format is not supported by software used in production department.

The outputs must specify the key characteristics of the products and services regarding their intended purpose and safe and proper provision.

All key characteristics must be stated in product or service specification. Also, all necessary information for the customer should be defined. Such as the content of instruction Manu. 

The design and development outputs must be documented in design review minutes or some similar form. 

- Design and development changes.

Very often there is need for changes during the design and development. Those changes should be identified, reviewed, and controlled in order to prevent their adverse effect on conformity to input requirements.

For example, the customer may require change in material to be used for production to reduce the cost, but the cheaper material may not be suitable for the intended use of the product.

The design and development changes must be identified and documented. So, the design team can clearly know what is expected from them. Also, able to review the changes to determine is it possible to apply them. Record for this review must be kept because there are necessary for the next step authorization of changes.

Depending on the results of changes review, the responsible person will allow changes to be applied or not and the record of authorization of changes must be kept.

The changes in design can have some adverse effects on some other parts of the design. This required from team to remove the adverse impact of the changes also to be documented and this usually through change review record

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