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SUBSTANTIAL change


jalomahe

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Our lab is having a discussion concerning what constitutes a SUBSTANTIAL/SIGNIFICANT change to a policy or procedure that would then require the director to review and approve the change.:confused:

If you have defined these terms for your lab would you be willing to share. Are your definitions included in a procedure concerning document control. I've seen several document control procedures on various websites that mention the terms but no where do I see the terms actually defined.

Thanks for your help

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CAP's definitions of Minor / Substantial revision......

Minor revision: A revision that does not affect the nature of a policy or the way in which a procedure is conducted. The revision would not affect patient results or patient outcomes. For example, a spelling or grammatical correction would be a minor revision.

Substantial revision: A change that affects the nature of a policy or the way in which a procedure is conducted that could impact patient test results or patient outcome.

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