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. 2021 May 25;35(6):e23804. doi: 10.1002/jcla.23804

TABLE 2.

Differences between protocols and SOPs.

Protocol SOP
Terminology usage Generic use or exclusive abbreviation Peer‐consensus standard
Purpose Aim for individual experiment design under specific application conditions Ensures the quality of all analytical phases
Document formation Separate file Composed by one or more relevant protocols or other controlled documents
Applicability Scientific medical research or unaccredited tests Clinical routine or accredited tests
Files compiler Manufacturer, designers, and developers Clinical laboratory managers and peer experts
Revision procedures Depend on each developer for individual experiments If revisions are required, re‐authorization is needed
Description scope Often described for specific operation step sonly Detailed normative description for the entire procedure
Personnel requirements Professionals or scientists Clinical laboratory staff or peers
Feasibility of implementation Options or references Mandatory implementation once approved