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.

AML Christensen’s service

At AML Christensen we have the experience to develop Standard Operating Procedures (SOPs) that align with your Quality Management System (QMS). This may include SOPs such as (non-exhaustive):

SOP for Clinical Evaluations
SOP for Post Market Surveillance (PMS)
SOP for Post Market Clinical Follow-Up (PMCF)
SOP for Risk Management
SOP for Clinical Development
SOP for Clinical Investigations

These SOPs can help your organization to comply with legal and regulatory standards by documenting procedures that meet the regulatory requirements. This can be essential for passing audits and inspections. Moreover, the SOPs ensure that tasks are performed consistently and correctly, leading to uniformity in product or service quality.

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Standard operating procedure (SOP)

What is a Standard Operating Procedure?

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