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Applicability in custom plans

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Diego, Nov 2, 2017.

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  1. Diego

    Diego New Member

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    Hi. Thank you for anyone help that I can get.

    I work in a laboratory. We do not design the exams that we do to our patients. However, we have plans for users who want it (for example preference in care, more coverage, more exams).

    Do having and developing customized plans for users make it necessary to include design and development clauses?

    Would this make the design and development have applicability?

    Thank you again
     
    Diego, Nov 2, 2017
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  2. tony s

    tony s Well-Known Member

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    Who designs the exams for the patients?
     
    tony s, Nov 3, 2017
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