Regulatory Support and Certifications

1. Regulatory Compliance Support

Santane ensures that projects and facilities comply with applicable legal, environmental, and occupational safety regulations at every stage of development and operation.
Our services include:

• Identification and interpretation of regulatory requirements (EU Directives, national laws, local authority guidelines).

• Preparation of compliance matrices, documentation, and regulatory registers.

• Liaison with government authorities, environmental agencies, and certification bodies.

• Support during audits, inspections, and permitting processes.

Examples of regulations supported:

• EU Machinery Directive (2006/42/EC)

• ATEX Directives (2014/34/EU and 1999/92/EC)

• Pressure Equipment Directive (2014/68/EU)

• Seveso III Directive (2012/18/EU)

• Environmental Impact Assessment (EIA) Regulations

• Occupational Health & Safety (ISO 45001) and Environmental (ISO 14001) standards

2. Certification Support

Santane assists clients in achieving the required equipment, system, and organizational certifications through coordination with accredited certification bodies and technical authorities.
Our support covers:

• Preparation of technical documentation, risk analyses, and conformity assessments.

• Guidance on CE marking and Declaration of Conformity preparation.

• Support for functional safety certifications (IEC 61508 / IEC 61511).

• Assistance in obtaining ISO management system certifications:

  • ISO 9001 (Quality)

  • ISO 14001 (Environment)

  • ISO 45001 (Occupational Health & Safety)

  • ISO 50001 (Energy Management)

• Compliance verification for safety instrumented systems (SIS) and control systems.

3. Functional Safety Certification and Verification

Building on Santane’s expertise in process safety and SIL verification, we offer:

• SIL Determination, Verification, and Validation in accordance with IEC 61511.

• Review and certification of Safety Requirement Specifications (SRS) and Safety Instrumented Functions (SIFs).

• Preparation of Functional Safety Assessment (FSA) Reports to demonstrate compliance.

• Coordination with third-party assessors or certification bodies (e.g., TÜV, DNV, Exida).

4. Environmental and Fire Safety Certification

• Support for environmental permits and emission control compliance.

• Preparation of Fire Risk Assessments and Fire Protection Philosophy documents for approval by fire authorities.

• Certification readiness for fire detection and suppression systems in accordance with EN and NFPA standards.