Regulatory compliance: definition and how to become compliant
What regulatory compliance covers, how to run a compliance project step by step, who is responsible for it, and why digital regulation has changed the picture.
Regulatory compliance means following the laws, regulations and standards that apply to your business, and being able to prove it. Once confined to banking and legal teams, it has become everyone's business with the GDPR, NIS 2, DORA, the AI Act and the Cyber Resilience Act. This article sets out the definitions, a six-step approach to becoming compliant and who does what. For day-to-day management once the project is over, see our article on cybersecurity compliance management.
What is compliance?
In an organisation, compliance is the set of means that ensure its activity follows the rules that apply to it. Those rules come from several sources:
- laws and regulations, national and European: this is regulatory compliance in the strict sense;
- professional standards and industry frameworks, imposed by a supervisor or a sector;
- contractual commitments, increasingly security clauses required by customers;
- internal rules: code of conduct, policies, procedures.
French banking regulation offers one of the most precise definitions. The order of 3 November 2014 on internal control in banks and investment firms describes compliance risk as the risk of a judicial, administrative or disciplinary sanction, a significant financial loss or reputational damage arising from failure to follow the rules specific to the business. The definition works in any sector: non-compliance is paid for in fines, lost contracts and lost trust.
There is also an international standard to organise the subject: ISO 37301, published in 2021, sets out the requirements for a compliance management system. It is designed for any organisation, whatever its size, and can be certified. Among other things, it requires you to identify your obligations, assess compliance risks and secure leadership commitment. Compliance is the "C" in GRC (governance, risk and compliance).
The main areas of regulatory compliance
Each area has its own texts and supervisor. The most common ones for a company operating in France:
| Area | Example texts | Supervisor in France |
|---|---|---|
| Banking and financial internal control | Order of 3 November 2014, DORA regulation | ACPR, AMF |
| Anti-corruption | Sapin II law, Article 17 | French Anti-Corruption Agency (AFA) |
| Personal data | GDPR, French Data Protection Act | CNIL |
| Cybersecurity | Military programming law, NIS 2 | ANSSI |
| Digital products and AI | Cyber Resilience Act, AI Act | Market surveillance authorities |
Thresholds vary from one text to another. Article 17 of the Sapin II law, for example, only covers companies with at least 500 employees and turnover above €100 million, or belonging to such a group: they must deploy an eight-measure anti-corruption programme, supervised by the AFA. The GDPR, by contrast, applies to any organisation that processes personal data, whatever its size.
Compliance and digital: what has changed
For a long time, IT compliance in France boiled down to the GDPR and, for a few hundred operators, the military programming law. Three shifts have changed the scale of the subject.
Texts piling up
Since 2022, the European Union has adopted NIS 2, DORA, the AI Act and the Cyber Resilience Act, each with its own security requirements, reporting deadlines and penalties. One company may fall under three or four of them. Our article on compliance management reviews them one by one; the one on cybersecurity frameworks presents the standards to build on.
Accountability moving up to the board
Article 20 of NIS 2 requires management bodies to approve cybersecurity measures and oversee their implementation; Article 5 of DORA gives them ultimate responsibility for managing ICT risk. Digital compliance is no longer something you can delegate entirely to IT.
Requirements flowing down the supply chain
A company covered by none of these texts may still have to comply through its contracts. Customers subject to NIS 2 or DORA pass their obligations on to suppliers through questionnaires and clauses (see what NIS 2 and DORA require regarding providers). For many smaller companies, this is how cyber compliance arrives.
Becoming compliant step by step
A compliance project takes an organisation from a non-compliant state to a compliant, demonstrable one. Whatever the text, it follows the same six steps.
1. List the applicable requirements
Which texts apply, to what scope (entities, sites, activities, products, processing) and by when? Include contractual requirements and your own rules. This work then continues as an organised regulatory watch, otherwise the list will be wrong within six months.
2. Assess the gaps
Compare your practices with each requirement. Interviews, questionnaires, document reviews and technical checks complement each other; a cybersecurity audit can be the starting point. Each requirement gets a status (compliant, partly compliant, non-compliant) and a justification.
3. Prioritise and plan
Not all gaps are equal. Rank them by the risk they create, using your risk analysis, and by regulatory deadlines. The action plan sets a measure, an owner, a deadline and a budget for each gap. Senior management approves it, since it decides on resources.
4. Implement
Measures are organisational (governance, procedures, training, supplier clauses) and technical (access management, logging, backups, encryption). Internal rules are written into policies, such as the information security policy for the cyber side.
5. Document and prove
The GDPR set the principle in 2018: the controller must comply and be able to demonstrate compliance (Article 5(2)). The same logic applies to other texts. Attach dated, current evidence to each requirement: register, minutes, test report, configuration screenshot, training record.
6. Maintain
A compliance project that stops at the final report starts degrading the next day: new texts, new systems, staff turnover, changing suppliers. The project must lead to an ongoing activity of controls and updates, compliance management, which automating some checks turns into continuous compliance.
Who does what: compliance officer, DPO and CISO
In most organisations, three functions share the subject under senior management's responsibility. Their missions overlap without merging.
| Function | What it covers | Framework |
|---|---|---|
| Compliance function | Mapping obligations, assessing compliance risk, advising and alerting management, often anti-corruption and ethics too | Mandatory in the financial sector; elsewhere, an organisational choice |
| Data protection officer (DPO) | Informing and advising, monitoring GDPR compliance, advising on impact assessments, cooperating with the supervisory authority | GDPR, Articles 37 to 39; mandatory in three cases |
| Chief information security officer (CISO) | Security measures, digital risk analysis, meeting NIS 2, sector or ISO 27001 requirements | No general legal status; role defined by the organisation |
The DPO enjoys specific protection: they cannot be dismissed or penalised for performing their tasks, and the organisation must give them the resources to act (GDPR Articles 37 to 39, explained in the CNIL's practical guide). They may hold other roles provided they do not end up marking their own homework: the CNIL considers, for instance, that the DPO should not decide the purposes and means of the processing they monitor. A CISO can therefore be appointed DPO only if, as CISO, they have no decision-making power over the processing.
The CISO and the DPO work on shared topics such as personal data security, data breaches or impact assessments, but from different angles: the former protects the organisation and its information, the latter the rights of individuals. The compliance function, where it exists, ensures overall consistency and reports to management. In a small company, two or three people often wear all these hats; what matters is that every requirement has a named owner. The detailed day-to-day split is in our article on compliance management.
Pitfalls of a compliance project
- Paper compliance. Well-written policies that nobody follows. Auditors and regulators ask for proof that a rule works, not just that it exists.
- One text, one project. Handling the GDPR, then NIS 2, then DORA as three separate projects means assessing the same measures three times. A common set of controls, for example built around an ISO 27001 ISMS, works better.
- A vague scope. Without a written scope, the gap assessment has no baseline and the project has no end.
- Forgetting suppliers. Part of your obligations rests on your providers: hosting, managed services, software vendors. Assessing them is part of the work (see third-party risk management).
- Stopping at the report. Without an owner and regular controls after the project, the level reached erodes within months.
How Phinasoft helps
Phinasoft is a French governance, risk and compliance platform dedicated to cybersecurity. For a compliance project, it lets you:
- start from the texts: a catalogue of more than twenty frameworks, including ISO 27001/2, NIS 2, DORA and the GDPR, to which you add your security policy or any other framework, with requirements linked to each other (frameworks module);
- assess the gaps through assessment campaigns across your entities, with evidence uploads;
- prioritise with risk analyses, then follow the action plan with deadlines and reminders;
- stay compliant with recurring controls and dashboards for management.
The DPO and the CISO work from the same base, each with their own access rights. To see how to move from gap assessment to action plan on your own scope, book a demo.
Summary
Meeting the rules, and proving it
Being compliant means following the rules that apply to your business and being able to demonstrate it. Without evidence, compliance does not exist in the eyes of a regulator or a customer.
A project, then an ongoing activity
A compliance project closes gaps in six steps: requirements, gap assessment, action plan, implementation, evidence, maintenance. Ongoing compliance management then takes over.
Distinct roles
The compliance function, the DPO and the CISO do different jobs. Senior management remains accountable: NIS 2 and DORA say so in black and white.
Frequently asked questions
What is regulatory compliance?
Regulatory compliance means that an organisation follows the laws, regulations and professional standards that apply to its business, and can demonstrate it. It covers many areas: personal data protection, cybersecurity, anti-corruption, and sector rules in finance or healthcare.
What is the difference between a compliance project and compliance management?
A compliance project starts from a gap assessment, closes the gaps and produces evidence, often ahead of a regulatory deadline or an audit. Compliance management is the ongoing activity that follows: monitoring new texts, regular controls, handling new gaps and keeping evidence up to date.
How long does it take to become compliant?
No text sets a duration: it depends on the number of requirements, the size of the gaps and the resources available. The gap assessment shows the size of the job; the action plan then sets realistic deadlines, dealing first with the gaps that expose the organisation most.
Who is responsible for compliance in a company?
Ultimate responsibility lies with senior management. Recent EU texts make this explicit: NIS 2 requires management bodies to approve and oversee cybersecurity measures, and DORA gives them ultimate responsibility for ICT risk. The compliance function, the DPO and the CISO each organise and monitor their own area.
Can the DPO be responsible for compliance?
The DPO monitors GDPR compliance and advises the organisation, but responsibility for compliance remains with the controller. The DPO may hold other roles provided they do not create a conflict of interest: the French data protection authority, the CNIL, considers for instance that the DPO should not decide the purposes and means of the processing they monitor.
Is there a standard for compliance?
Yes. ISO 37301, published in 2021, sets the requirements for a compliance management system for any type and size of organisation. It can be certified. For information security, ISO 27001 plays a comparable role.
Sources (8)
- Légifrance — Arrêté du 3 novembre 2014 relatif au contrôle interne des entreprises du secteur de la banque, des services de paiement et des services d'investissement
- ISO/TC 309 — ISO 37301:2021, Compliance management systems — Requirements with guidance for use
- Agence française anticorruption — Acteurs économiques (article 17 de la loi Sapin II)
- EUR-Lex — Règlement (UE) 2016/679 (RGPD), articles 5, 37 à 39
- EUR-Lex — Directive (UE) 2022/2555 (NIS 2), article 20
- EUR-Lex — Règlement (UE) 2022/2554 (DORA), article 5
- CNIL — Guide pratique RGPD : délégués à la protection des données
- CNIL — Délégué à la protection des données : identifier et gérer les conflits d'intérêts
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