ISO 13485:2016
Medical Devices

ISO 13485:2016

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

ISO 9001:2015 QMS

Quality Management System

ISO 14001:2015 EMS

Environmental Management System

ISO 45001:2018 OH&S

Occupational Health & Safety

ANSI/ASIS PSC1:2012

Quality Management System

ISO 18788:2015

Quality Management system for Private Securities companies

ISO 22000:2018

Food Safety Management System

HACCP

Hazard Analysis Critical Control Point

ISO 20000

Information technology Service Management

ISO 22301:2019

Business continuity management systems

ISO 27001:2013

Information Security Management System

ISO 50001:2018

Energy Management System

ISO 31000:2018

Risk Management System

IMS

Integrated Management System

ISO 29001:2020

Quality Management System for Oil & Gas Companies

ISO 21500:2012

Guidance on project management

ISO 37001:2016

Anti-Bribery Management System

ISO 13485:2016

Medical Devices

ISO 39001:2012

Road Traffic Safety Management System

ISO 10002:2018

Quality management - Customer Satisfaction Standard

Halal Food

(Halal Food / Meat-Islam base-Slaughtering/ IFS: International Featured Standards

Global GAP /OC

Good Agricultural Practices / Organic Certification

UL / CE Mark

Product Certification

ISO 17025

Testing and Calibration Laboratories-Board Accreditation

15189:2012

Medical Laboratories Accreditation

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