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ISO and GRC certification consulting in Romania
Achieve ISO and GRC certification in Romania with Sterling: 8,100+ client engagements in 60+ countries, 20+ years.
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Sectors that ask for certification in Romania
Clients include
ISO and GRC certification in Romania at a glance
Romania's certification market is shaped by an export-heavy manufacturing base, a regulated financial and digital sector, and a cyber security framework that arrived through Emergency Ordinance no. 155/2024. The Ordinance, published in the Official Gazette of 31 December 2024 and approved with amendments by Law no. 124/2025, makes DNSC, the National Cyber Security Directorate, the competent authority for NIS2. ANSPDCP, the National Supervisory Authority for Personal Data Processing, enforces the GDPR alongside Law no. 190/2018, which also routes accreditation of GDPR certification bodies to RENAR. RENAR, the Romanian Accreditation Association, is the national accreditation body and says it is an EA multilateral agreement signatory for management system certification, laboratories, inspection, and product and person certification. The European Commission's 2026 country report puts automotive at about one third of goods exports, and knowledge-intensive export services led by ICT reached 7.1% of GDP in 2025. Certificates come from accredited certification bodies, never from Sterling. Sterling serves Romanian clients from its Frankfurt office, backed by 8,100+ client engagements in 60+ countries and 20+ years of experience, with Effivity and Sterling Academy included.
ISO and GRC standards Sterling delivers in Romania
Each card opens Sterling's guide to the standard: what it requires, how certification or compliance works and what sets the time and cost.
Quality & operational excellence
Information security, cyber & cloud
Privacy & data protection
AI governance & digital trust
Environment, energy & climate
Health & safety
Governance, risk & resilience
Financial services, payments & AML
Food safety & agriculture
Healthcare, medical devices & life sciences
Laboratories, inspection & accreditation
Automotive, aerospace, rail & defence
Construction, energy, oil & gas
Regulators and laws that drive certification in Romania (11)
| Law or regulator | What it asks for | Standards it cites |
|---|---|---|
| General Data Protection Regulation (GDPR) and Romania's Law no. 190/2018 ANSPDCP (Autoritatea Națională de Supraveghere a Prelucrării Datelor cu Caracter Personal, the National Supervisory Authority for Personal Data Processing) — set up under Law no. 102/2005 as an autonomous and independent public authority | The Law sets national rules for genetic, biometric and health data, for the national identification number (with listed safeguards), for employee monitoring and video surveillance, for processing in the public interest, for journalistic, academic, artistic and literary expression, for archiving and research, and for data protection officers. It also deals with accreditation of certification bodies and with corrective measures. | |
| Accreditation of GDPR certification bodies RENAR, as the national accreditation body, with the supervisory authority setting additional requirements | The Law says accreditation of the certification bodies provided for in the GDPR is carried out by RENAR under Regulation (EC) No 765/2008 and the national accreditation ordinance, and that those bodies are accredited to ISO/IEC 17065 plus the additional requirements set by the National Supervisory Authority. | |
| Whistleblower protection Each public authority and entity runs its own reporting mechanism under the Law; the Ministry of the Interior publishes its mechanism as an example | The Ministry of the Interior's guidance lists the areas covered, including public procurement, financial services and anti-money-laundering, product and food safety, environmental protection and data protection, and says the Law applies to workers and the self-employed who report breaches learned in a professional context. | |
| DNSC (Directoratul Național de Securitate Cibernetică, the National Cyber Security Directorate), which the Ordinance designates as the competent authority and national CSIRT; sector authorities such as ANCOM for digital infrastructure and postal services and ADR for trust service providers cooperate with it Essential and important entities in the sectors listed in the Ordinance's two annexes, among them energy, transport, banking, financial market infrastructure, health, digital infrastructure, ICT service management, public administration, postal services, waste, chemicals, food, manufacturing, digital providers and research | Ordonanța de urgență nr. 155/2024 privind instituirea unui cadru pentru securitatea cibernetică a rețelelor și sistemelor informatice din spațiul cibernetic național civil (Emergency Ordinance no. 155/2024), dated 30 December 2024 and published in the Official Gazette, Part I, no. 1332 of 31 December 2024. It states that it transposes Directive (EU) 2022/2555, and Parliament's texts record that it was approved with amendments and completions by Law no. 124/2025. A later bill amending it appears on the Senate's site. DNSC keeps the register of essential and important entities, risk-management measures are approved and overseen by management bodies, and the cyber security audit is carried out by auditors attested by DNSC. The text refers to relevant standards and good practice but does not name ISO/IEC 27001 or ISO 22301. | ISO/IEC 27001, ISO 22301 |
| BNR (Banca Națională a României, the National Bank of Romania) and ASF (Autoritatea de Supraveghere Financiară, the Financial Supervisory Authority), as the Ordinance names them Financial entities (banks, insurers, investment firms, payment institutions and others in DORA's scope) | Regulation (EU) 2022/2554 (DORA), which applies from 17 January 2025. The Ordinance provides that DNSC cooperates with BNR and ASF on cyber risk for banking and financial market infrastructure entities and that BNR and ASF pass DNSC information on major ICT incidents reported under DORA. ASF publishes a DORA page. These sources do not name ISO/IEC 27001. | |
| ANMDMR (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România, the National Agency for Medicines and Medical Devices) Medical device manufacturers, importers, distributors and service providers | Regulation (EU) 2017/745 (Medical Device Regulation), whose Article 10 requires manufacturers to run a quality management system. ANMDMR says it registers medical devices placed on the market and their manufacturers, authorised representatives, importers and distributors, carries out market surveillance, and issues operating approvals for import, distribution, installation and maintenance of devices. Its pages do not name ISO 13485. | |
| ANSVSA (Autoritatea Națională Sanitară Veterinară și pentru Siguranța Alimentelor, the National Sanitary Veterinary and Food Safety Authority) Food businesses | Regulation (EC) No 852/2004, Article 5, requires food business operators to maintain permanent procedures based on the HACCP principles. The EU food safety authority's country page describes ANSVSA as the regulatory authority for sanitary-veterinary matters and food safety, which monitors food activities and authorises entities in the food chain. Neither source makes a third-party certificate compulsory. | HACCP |
| ANRE (Autoritatea Națională de Reglementare în domeniul Energiei, the National Energy Regulatory Authority), whose Energy Efficiency Department works under Law no. 121/2014 Large energy users (energy management systems and energy audits) | Directive (EU) 2023/1791 on energy efficiency, Article 11, requires enterprises above a consumption threshold to implement an energy management system certified by an independent body against relevant European or international standards, and requires energy audits for smaller large users. ANRE describes Law no. 121/2014 as transposing the earlier energy efficiency directive and handling authorisation of energy auditors. Neither source names ISO 50001. | ISO 50001 |
| The Labour Inspection bodies and the ministry responsible for labour, as EU-OSHA describes the national system Occupational health and safety (employers in all sectors) | Legea nr. 319/2006 privind securitatea și sănătatea în muncă (Law No. 319 of 14 July 2006 on Safety and Health at Work), listed by EU-OSHA as the primary general-principles law. It does not name ISO 45001. | |
| EU framework; the national supervisory arrangements are for the competent Romanian authorities to confirm Providers and deployers of AI systems | Regulation (EU) 2024/1689 (Artificial Intelligence Act), which lays down harmonised rules on artificial intelligence. It is a regulation, not a certification scheme, and it does not name ISO/IEC 42001. | |
| ANMDMR (the National Agency for Medicines and Medical Devices) Medicine manufacturers and wholesale distributors | ANMDMR says its remit includes authorisation of medicines for human use and of manufacturing and wholesale distribution units, and supervision of those units and of medicine quality on the market. Its pages do not name ISO standards. |
Accreditation and recognition
- RENAR (Asociația de Acreditare din România, the Romanian Accreditation Association): National accreditation body — Law no. 190/2018 calls RENAR the national accreditation body under Regulation (EC) No 765/2008, and RENAR says it is assessed by peer evaluation organised by EA.
Look for a certification body whose accreditation scope covers your standard and sector, from a national accreditation body recognised under the international arrangements of Global ACI (Global Accreditation Cooperation Incorporated, formerly the IAF MLA). Sterling does not certify.
Tenders and procurement
- Public procurement under the EU public procurement directives as applied by Romanian contracting authorities (Contracting authorities): Each contracting authority sets its own conditions in the tender documents. Where it asks for certificates from independent bodies on quality assurance, Directive 2014/24/EU, Article 62, directs it to systems based on the relevant European standards and certified by accredited bodies, and for environmental management to EMAS or other standards certified by accredited bodies. Equivalent certificates from bodies in other Member States must be recognised.
Economic zones
- Customs free zones reported by Romania to the European Commission: logistics and port-linked industry, manufacturing, trade
- Romanian automotive manufacturing base: automotive, components, industrial equipment
- ICT and export-oriented services: ICT, software and IT services, shared services
- Foreign-owned manufacturing clusters: pharmaceuticals and chemicals, electronics, aviation components
Sterling in Romania
Sterling delivers in Romania from its Frankfurt office: one team from scoping to certificate, with Effivity ISO & GRC software and Sterling Academy access included. Sterling does not certify; certification decisions stay with independent bodies.
Questions Romania clients ask
Which language will a Romanian audit run in?
Plan for Romanian, English or a mix. The certification body fixes the audit language with you at application: Romanian is the official language and English is commonly used in business. What matters is which language the auditors must read in your procedures and records, and whether a customer contract or regulator procedure overrides your preference.
Does the Romanian NIS2 Ordinance reach foreign groups?
It covers entities in the annex sectors that are established and registered in Romania. As published, it also reaches public electronic communications providers serving Romania wherever they are established, and digital infrastructure and service providers whose main EU establishment is in Romania. Foreign public administration bodies fall under their own state. Check your establishment facts with counsel.
Which authority supervises the GDPR in Romania?
ANSPDCP, the National Supervisory Authority for Personal Data Processing, which Law no. 102/2005 set up as an autonomous and independent public authority. Law no. 190/2018 supplements the GDPR with national rules on health and biometric data, identification numbers, employee monitoring and data protection officers. For a specific processing activity, ask the authority or your counsel.
Which body accredits certification bodies in Romania?
RENAR, the Romanian Accreditation Association. Law no. 190/2018 names it the national accreditation body, and its own communiqué lists EA multilateral agreement signatory status for management system certification, laboratories, inspection, and product and person certification. Recognition is by scope, so check the exact scope of the certification body you choose for your standard.
Do Romanian public buyers ask for ISO certificates?
Sometimes. Romanian tenders follow EU procurement rules in which the buyer writes its own qualification conditions. Under Directive 2014/24/EU, Article 62, a request for quality or environmental certificates must point to systems certified by accredited bodies and accept equivalent certificates from other Member States. Your bid team should study the specific notice.
Does ISO/IEC 27001 satisfy the Romanian cyber security audit?
Not by itself. As published, Emergency Ordinance no. 155/2024 requires essential and important entities to undergo a cyber security audit by auditors holding a DNSC attestation, at a frequency set by a DNSC order. An ISO/IEC 27001 certificate can support your evidence, but DNSC decides what counts. Confirm with DNSC or your counsel.
Start with a free discovery call
A Sterling consultant goes through your entities, your regulators and your target date with you. No proposal until the scope is agreed.
Sources
- General Data Protection Regulation (GDPR) and Romania's Law no. 190/2018 — dataprotection.ro; eur-lex.europa.eu (accessed 18 Oct 2026)
- Accreditation of GDPR certification bodies — dataprotection.ro (accessed 18 Oct 2026)
- Whistleblower protection — mai.gov.ro (accessed 18 Oct 2026)
- Ordonanța de urgență nr. 155/2024 privind instituirea unui cadru pentru securitatea cibernetică a rețelelor și sistemelor informatice din spațiul cibernetic național civil (Emergency Ordinance no. 155/2024), dated 30 December 2024 and published in the Official Gazette, Part I, no. 1332 of 31 December 2024. It states that it transposes Directive (EU) 2022/2555, and Parliament's texts record that it was approved with amendments and completions by Law no. 124/2025. A later bill amending it appears on the Senate's site. DNSC keeps the register of essential and important entities, risk-management measures are approved and overseen by management bodies, and the cyber security audit is carried out by auditors attested by DNSC. The text refers to relevant standards and good practice but does not name ISO/IEC 27001 or ISO 22301. — senat.ro; eur-lex.europa.eu (accessed 18 Oct 2026)
- Regulation (EU) 2022/2554 (DORA), which applies from 17 January 2025. The Ordinance provides that DNSC cooperates with BNR and ASF on cyber risk for banking and financial market infrastructure entities and that BNR and ASF pass DNSC information on major ICT incidents reported under DORA. ASF publishes a DORA page. These sources do not name ISO/IEC 27001. — eur-lex.europa.eu; senat.ro; asfromania.ro (accessed 18 Oct 2026)
- Regulation (EU) 2017/745 (Medical Device Regulation), whose Article 10 requires manufacturers to run a quality management system. ANMDMR says it registers medical devices placed on the market and their manufacturers, authorised representatives, importers and distributors, carries out market surveillance, and issues operating approvals for import, distribution, installation and maintenance of devices. Its pages do not name ISO 13485. — eur-lex.europa.eu; anm.ro (accessed 18 Oct 2026)
- Regulation (EC) No 852/2004, Article 5, requires food business operators to maintain permanent procedures based on the HACCP principles. The EU food safety authority's country page describes ANSVSA as the regulatory authority for sanitary-veterinary matters and food safety, which monitors food activities and authorises entities in the food chain. Neither source makes a third-party certificate compulsory. — eur-lex.europa.eu; efsa.europa.eu (accessed 18 Oct 2026)
- Directive (EU) 2023/1791 on energy efficiency, Article 11, requires enterprises above a consumption threshold to implement an energy management system certified by an independent body against relevant European or international standards, and requires energy audits for smaller large users. ANRE describes Law no. 121/2014 as transposing the earlier energy efficiency directive and handling authorisation of energy auditors. Neither source names ISO 50001. — eur-lex.europa.eu; arhiva.anre.ro (accessed 18 Oct 2026)
- Legea nr. 319/2006 privind securitatea și sănătatea în muncă (Law No. 319 of 14 July 2006 on Safety and Health at Work), listed by EU-OSHA as the primary general-principles law. It does not name ISO 45001. — oshwiki.osha.europa.eu (accessed 18 Oct 2026)
- Regulation (EU) 2024/1689 (Artificial Intelligence Act), which lays down harmonised rules on artificial intelligence. It is a regulation, not a certification scheme, and it does not name ISO/IEC 42001. — eur-lex.europa.eu (accessed 18 Oct 2026)
- ANMDMR says its remit includes authorisation of medicines for human use and of manufacturing and wholesale distribution units, and supervision of those units and of medicine quality on the market. Its pages do not name ISO standards. — anm.ro (accessed 18 Oct 2026)
- RENAR (Asociația de Acreditare din România, the Romanian Accreditation Association) — renar.ro; dataprotection.ro (accessed 18 Oct 2026)
- Public procurement under the EU public procurement directives as applied by Romanian contracting authorities — eur-lex.europa.eu (accessed 18 Oct 2026)
- Customs free zones reported by Romania to the European Commission — taxation-customs.ec.europa.eu (accessed 18 Oct 2026)
- Romanian automotive manufacturing base — economy-finance.ec.europa.eu (accessed 18 Oct 2026)
- ICT and export-oriented services — economy-finance.ec.europa.eu (accessed 18 Oct 2026)
- Foreign-owned manufacturing clusters — economy-finance.ec.europa.eu (accessed 18 Oct 2026)
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