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Exclusion of clause 7.3 Design and Development

ISO 9001
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Guest user Created:   Jan 12, 2016 Last commented:   Jan 12, 2016

Exclusion of clause 7.3 Design and Development

ISO 9001
 Design and development. When do you exclude design and development in your Quality Management System?
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ISO 9001 SCOPE OF THE QUALITY MANAGEMENT SYSTEM

Define the scope of the QMS and its boundaries.

ISO 9001 SCOPE OF THE QUALITY MANAGEMENT SYSTEM

Define the scope of the QMS and its boundaries.
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StrahinjaS Jan 12, 2016

Design and development can be excluded when organization doesn't perform design of new products or development of existing products. This clause can also be excluded when the design and development are outsourced.

Here is one article explaining design and development process: ISO9001 Design Verification vs Design Validation https://advisera.com/9001academy/knowledgebase/iso9001-design-verification-vs-design-validation/

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Jan 12, 2016

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