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 |