ISO 13485

Medical Devices

ISO 13485 Medical devices  Quality management systems — Require for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Benefits

  • Increased quality of product/services.
  • Decreased operational cost.
  • Decreased production loss rate.
  • Increased customer satisfaction.
  • Increased efficiency.
  • Minimize mistakes.

ISO Certifications and Standards

Quality Management System

Environmental Management System

Occupational Health & Safety

ANSI/ASIS PSC1:2012

Quality Management system for Private Securities companies

Food Safety Management System

Hazard Analysis Critical Control Point

Information technology Service Management

Business continuity management systems

Information Security Management System

Energy Management System

Risk Management System

IMS

Integrated Management System

ISO 29001:2020

Guidance on project management

ISO 37001:2016

ISO 13485:2016

ISO 39001:2012

Quality management – Customer Satisfaction Standard

Halal Food/Meat-Islam base-Slaughtering

Testing and Calibration Laboratories-Board Accreditation