Certifications & Compliance – Kerone Engineering Solutions
Quality Assurance · Global Compliance

Certifications
& Compliance

KERONE's commitment to quality excellence is validated through international certifications, rigorous testing protocols, and adherence to global industry standards — ensuring every system meets the highest requirements for safety, quality, and performance.

ISO 9001:2015
Certified Since 1995
CE Certified
EU Conformity
cGMP Compliant
Pharma Grade
ATEX Approved
Zone 1 & 2

Major Certifications

Internationally recognised quality and compliance certifications validating KERONE's engineering excellence.

European Market

CE Certification

European Conformity Marking

European conformity marking indicating full compliance with EU health, safety, and environmental protection standards for machinery and pressure equipment directives.

Valid Through 2028
Pharmaceutical

cGMP Compliant

Current Good Manufacturing Practice

Current Good Manufacturing Practice certification for pharmaceutical-grade equipment design and fabrication — including full validation documentation (DQ/IQ/OQ/PQ) support.

Certified Since 2000
Explosion Protection

ATEX Certification

Zone 1 & 2 · IECEx

Explosion protection certification for equipment used in potentially explosive atmospheres — Zones 1 & 2 for chemical, petrochemical, and hazardous material processing environments.

Valid Through 2026
Pressure Vessels

ASME Certification

U-Stamp · Pressure Vessel Design

American Society of Mechanical Engineers certification for pressure vessel design and fabrication — ASME U-stamp enabling export and installation across North American markets.

Certified Since 2005
US Market

FDA Compliance

Food & Drug Administration

Food and Drug Administration compliance for equipment used in food and pharmaceutical manufacturing — covering 21 CFR Part 11 electronic records and equipment registration requirements.

Registered 2010

Industry Standards

KERONE equipment meets international industry-specific standards across all major sectors and geographies.

HACCP

Hazard Analysis Critical Control Points for food safety management systems — compliant equipment design for all food processing applications.

OSHA

Occupational Safety and Health Administration workplace safety compliance for all industrial equipment supplied to US installations.

ISO 14001

Environmental Management System for sustainable manufacturing practices — reducing environmental impact across KERONE's production operations.

IEC Standards

International Electrotechnical Commission electrical safety standards for all control panels, drives, and electrical systems.

3-A Sanitary

Sanitary equipment standards for dairy and food processing industries — drainable geometry, polished surfaces, hygienic design throughout.

21 CFR Part 11

FDA electronic records and electronic signatures compliance for pharmaceutical PLC/SCADA control systems with full audit trail.

NFPA

National Fire Protection Association codes for industrial equipment — fire prevention, detection, and suppression system integration.

BIS Standards

Bureau of Indian Standards certification for domestic market compliance — ensuring KERONE equipment meets all Indian regulatory requirements.

100%
Compliance Rate
25+
Years ISO Certified
12+
Active Certifications
50+
Countries Approved
ISO 9001:2015

Quality Management Framework

Our ISO-certified quality management system ensures consistent excellence from initial design through delivery and long-term after-sales support. Every KERONE system undergoes rigorous quality checkpoints, validation protocols, and performance testing before leaving our Ambernath facility.

  • Document control and revision management system
  • Supplier quality audits and raw material qualification
  • In-process inspection at all critical fabrication stages
  • Final acceptance testing and performance validation (FAT)
  • Non-conformance tracking and corrective action reporting
  • Continuous improvement and Kaizen programs
  • Customer feedback integration and satisfaction monitoring
  • Internal quality audits and management review cycles

Testing & Validation Facilities

State-of-the-art testing capabilities at Ambernath ensure performance, safety, and compliance before every shipment.

Materials Testing Lab

Advanced metallurgy and material science testing for corrosion resistance, tensile strength, and weld quality validation — all contact surfaces inspected to Ra specification.

Electrical Safety Testing

Complete electrical safety testing including insulation resistance, earth continuity, hi-pot testing, and full load testing of control panels before despatch.

Performance Testing

Full-scale performance validation including temperature distribution mapping, heat transfer efficiency, evaporation rate, and energy consumption benchmarking.

Pressure & Leak Testing

Hydrostatic and pneumatic pressure testing to ensure system integrity. Vacuum and leak testing for all sealed systems and explosion-proof enclosures.

Calibration Laboratory

NABL-accredited calibration services for temperature, pressure, and flow measurement devices — traceable to national standards, with full calibration certificates.

Control System FAT

Factory Acceptance Testing (FAT) for PLC, SCADA, and automation systems — complete simulation of process sequences before site installation.

Certification Timeline

Five decades of building quality excellence — a milestone-by-milestone record of KERONE's commitment to certification and compliance.

1995

ISO 9001 Certification

Achieved first ISO 9001 certification — formalising quality management systems and establishing documented processes across design, manufacturing, and testing operations.

2000

cGMP Compliance Achieved

Received cGMP certification enabling pharmaceutical equipment manufacturing — opening the door to FDA-regulated clients and API manufacturing projects globally.

2005

ASME U-Stamp Certification

Obtained ASME U-stamp for pressure vessel design and fabrication — qualifying KERONE for high-pressure chemical and petrochemical processing equipment contracts.

2010

CE Mark & FDA Registration

Expanded certifications with CE marking for European market access and FDA establishment registration — enabling full export compliance for food and pharma clients in US and EU.

2015

ISO 9001:2015 Transition

Successfully transitioned to the updated ISO 9001:2015 standard with risk-based thinking framework — strengthening quality culture and introducing enhanced customer focus processes.

2020

ATEX & ISO 14001 Added

Added ATEX Zone 1 & 2 explosion protection certification and ISO 14001 Environmental Management System — completing the full suite of chemical processing compliance credentials.

Download Certificates

Access KERONE's certification documents and compliance reports for your project records or supplier qualification process.

ISO 9001:2015 Certificate

PDF · 2.4 MB
Download

CE Declaration of Conformity

PDF · 1.8 MB
Download

cGMP Compliance Certificate

PDF · 2.1 MB
Download

ATEX Certification

PDF · 3.2 MB
Download

ASME U-Stamp Certificate

PDF · 1.5 MB
Download

Quality Manual (ISO 9001)

PDF · 8.7 MB
Download

Quality at Scale

12+
Major Certifications

International & domestic

100%
Compliance Rate

Zero non-conformances

25+
Years ISO Certified

Continuous certification since 1995

50+
Countries Approved

Equipment accepted globally

Request Certification Documentation

Need specific certificates, compliance reports, or validation documentation for your project? Our quality team will respond within one business day.

Quality Enquiries
Supplier Qualification
Full quality pack available on request for SQA audits
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