The regulatory Monitoring enables an organization to ensure that its activities, facilities, equipment, and internal procedures comply with all applicable standards and regulations.
Key Steps:
Identifying applicable texts: the essential first stage of regulatory monitoring
This initial step is critical: it involves compiling all regulatory texts applicable to the organization’s various activities.
The company must then sort through the information collected—eliminating what is irrelevant and retaining only what is essential.
Assessing compliance
Regulatory monitoring is not an end in itself but rather a necessary and preparatory stage that enables an organization to evaluate the compliance of its activities, equipment, and internal procedures.
A compliance assessment (diagnosis) is then carried out on the basis of the applicable regulatory texts identified.
Defining a compliance action plan
If a non-conformity is identified, the organization must establish a corrective (and, where appropriate, preventive) action plan, depending on the nature of the non-conformity, while respecting the internal quality procedures in place.
The action plan is managed internally by the entity’s Quality Manager, following a clear process: action initiated → responsible party → deadline → closure.
Implementing the predefined action plan: the culmination of regulatory monitoring
The implementation of the action plan represents the final stage of regulatory monitoring.
Changes within the organization—particularly in terms of its activities—or evolving regulations may impact the requirements that apply to it, and consequently its compliance with these requirements.
Regulatory monitoring must therefore remain aligned with these changes in order to adjust the action plan where necessary.
To ensure that the list of applicable requirements remains up to date, compliance audits may also be carried out by an external body.