Art International

ISO Certification

ISO 13485:2016 provides a framework that helps medical device companies consistently meet customer and regulatory requirements while ensuring the safety and effectiveness of medical devices. It emphasizes risk management, regulatory compliance, and process control throughout the product lifecycle.

Certificate of Registration

ISO 14001:2015 provides a framework that enables organizations to identify, control, and reduce their environmental impact while ensuring compliance with environmental regulations. It supports organizations in improving environmental performance through efficient use of resources, waste reduction, and pollution prevention.

Quality Certificates

ISO 9001:2015 provides a structured framework that helps organizations consistently deliver products and services that meet customer and regulatory requirements while enhancing customer satisfaction through effective quality management practices. The standard is applicable to organizations of all sizes and industries.

IEC Certificates

The IEC is a mandatory registration for international trade in India. It allows companies to legally conduct import and export activities, clear shipments through customs, and receive or send foreign payments for trade transactions.

Our Certifications

ISO 45001:2018 provides a structured framework for organizations to identify workplace hazards, assess risks, and implement effective controls to improve occupational health and safety performance. The standard can be applied to organizations of any size, industry, or sector.

Achievements

The MD-42 declaration is used to:

• Declare that a medical device meets EU safety and performance requirements

• Support CE marking for medical devices

• Confirm compliance with the Medical Device Directive 93/42/EEC

• Allow the product to be sold in the European market

Recognition

WHO-GMP certification ensures that medicines and healthcare products are consistently produced and controlled according to international quality standards. It focuses on maintaining product safety, quality, and effectiveness during manufacturing.