Certifications and International Standards

Technical compliance, global confidence

Our approach combines technical expertise with regulatory commitment, ensuring that every deliverable meets or exceeds global industry standards.

Razzell Certificaciones y Normativas Internacionales

International Engineering and Manufacturing Standards

All equipment and systems developed by Razzell are designed and manufactured in accordance with the guidelines of:
• ASME (American Society of Mechanical Engineers) – design and fabrication of pressure vessels and industrial components.
• ISO (International Organization for Standardization) – quality management, energy efficiency, and operational safety.
• AWS (American Welding Society) – qualified welding procedures and traceability of critical joints.
• CE / PED (Pressure Equipment Directive) – European compliance for the safety and design of pressurized equipment.
• FDA & cGMP (Good Manufacturing Practices) – sanitary design and validation for the pharmaceutical and cosmetics industries.

Razzell Certificaciones y Normativas Internacionales

National Regulatory Compliance

Razzell’s projects and systems in Mexico are developed in accordance with the applicable Mexican Official Standards (NOM) in environmental, sanitary, and water-quality regulation:
• NOM-001-SEMARNAT – maximum permissible limits of contaminants in wastewater discharges to receiving bodies.
• NOM-002-SEMARNAT – wastewater discharges into municipal sewer systems.
• NOM-003-SEMARNAT – requirements for the reuse of treated wastewater.
• NOM-052-SEMARNAT – identification and management of hazardous waste.
• NOM-127-SSA1 – drinking water quality standards and permissible limits for human consumption.
• NOM-141-SEMARNAT – management of waste generated from mining and metallurgical processes.
• NOM-201-SSA1-2015 – sanitary specifications, materials, and testing methods for water-treatment devices and products intended for human consumption.

Razzell Certificaciones y Normativas Internacionales

Validation and Quality Assurance

Every system developed by Razzell undergoes a structured, comprehensive validation process based on internationally recognized protocols such as DQ, IQ, OQ, and PQ, ensuring full functionality, safety, and reproducibility of the system under real operating conditions.

It consists of the technical and documentary evaluation of the design prior to manufacturing.
The project is reviewed to ensure compliance with the user’s specifications, engineering criteria, selected materials, and applicable standards (ASME, ISO, FDA, NOM).
This step ensures that the design foundation is solid, verifiable, and audit-ready.

Stage in which all equipment, connections, and auxiliary systems are verified to have been installed correctly according to drawings, manuals, and technical standards. It includes physical inspection, electrical testing, initial calibration, and verification of critical components.
The result is the certification of the installation, ensuring mechanical and sanitary integrityof the system.

Stage in which the operation of the system is verified under controlled conditions, simulating real operating parameters.
Automatic sequences, alarms, safety functions, flows, pressures, temperatures, and digital controls are validated.
The objective is to confirm that the system operates within the design specifications and responds appropriately to deviations.

It is the final verification of the sustained performance of the system under normal working conditions.
During this phase, operational data is collected over a defined period to ensure that results are repeatable, stable, and compliant with customer or regulatory requirements.
This qualification guarantees that the system is capable of operating continuously, safely, and efficiently.

Each stage of the qualification process is documented through technical reports and signed conformity records, allowing the client to maintain full traceability from design to operation.
This process not only supports the overall quality of the system but also enables its use in regulated industries such as pharmaceutical, food, cosmetics, and biotechnology without requiring additional external validations.

Razzell Certificaciones y Normativas Internacionales

COMMITMENT TO SUSTAINABILITY AND SAFETY

Razzell integrates principles of energy efficiency, emissions reduction, and resource reuse into every project.
We also implement strict occupational safety and environmental guidelines based on ISO 45001, ISO 14001, and the EPA Clean Water Act, ensuring regulatory compliance in both national and international developments.