sääntelyauditointi

Sääntelyauditointi, or regulatory audit, is a systematic assessment of an organization’s compliance with applicable laws, regulations, and standards. The audit examines policies, procedures, and controls that govern operations in regulated sectors such as finance, healthcare, environmental protection, and food safety. Companies undertake sääntelyauditointi to demonstrate accountability to regulators, identify gaps in compliance, and mitigate legal or financial risks.

The audit process typically begins with a scoping phase that defines the regulatory framework and the specific requirements applicable to the entity. Auditors collect evidence through document review, interviews, and observation of processes. Risk‑based sampling is often employed to prioritize areas with the highest regulatory exposure. Key audit criteria include the adequacy of governance structures, the existence of up‑to‑date compliance manuals, the effectiveness of internal control systems, and the timeliness of reporting obligations.

Findings from a regulatory audit are compiled in a report that outlines strengths, weaknesses, and actionable recommendations. Remediation plans are usually developed collaboratively with management to close identified gaps. Follow‑up audits ensure that corrective actions have been implemented and that compliance has improved over time.

Regulatory audits are commonly required by national authorities such as the Finnish Financial Supervisory Authority (FIN-FSA) and European bodies like the European Medicines Agency (EMA). In many jurisdictions, auditors are certified professionals licensed by professional bodies or regulatory agencies. By maintaining transparent compliance records, organizations can avoid penalties, safeguard their reputation, and support continuous improvement of governance practices.

References

[1] Finnish Financial Supervisory Authority – Guidelines for Regulatory Audits

[2] European Medicines Agency – Audit Manual for Pharmaceutical Producers

[3] International Standards for the Professional Practice of Internal Auditing (IIA, IFAC)