Medical Standard operating procedure (SOP)

What is a Standard Operating Procedure?
A Standard Operating Procedure (SOP) is a documented set of step-by-step instructions created by an organization to help workers carry out routine operations. The purpose of an SOP is to ensure consistency and quality in the performance of specific functions by providing detailed guidelines that must be followed. SOPs are essential for maintaining safety, efficiency, and compliance with regulatory requirements, e.g. during clinical investigations.
AML Christensen’s service
At AML Christensen we have a broad experience in developing SOPs such as (non-exhaustive):
  • SOP for Clinical Evaluations
  • SOP for Clinical Development
  • SOP for Clinical Investigations
These SOPs ensure that your medical/clinical tasks are performed consistently and correctly, leading to uniformity in product or service quality. This can be essential for passing audits and inspections.
In addition, we can help you create regulatory SOPs that comply with your Quality Management System as described here.