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Applicability in laboratory

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Guillermo Created:   Oct 30, 2017 Last commented:   Nov 04, 2017

Applicability in laboratory

Hi. I work in a laboratory. We do not design the exams we do to patients. However, we have plans for users who want it (for example preference in care, more coverage, more exams). Would this make the design and development have applicability?
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ISO 9001 PROCEDURE FOR DESIGN AND DEVELOPMENT

Define the design & development process for smaller companies.

ISO 9001 PROCEDURE FOR DESIGN AND DEVELOPMENT

Define the design & development process for smaller companies.

Expert
Strahinja Stojanovic Nov 04, 2017
Hi Diego,

Actually no, the design and development requirements would be applicable only if you would design and develop new kinds of tests or methodologies for testing and examination.

Best regards,

Strahinja
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Oct 30, 2017

Nov 04, 2017

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Clause 8.3. applicability