Path-Tec Earns ISO 13485 Certification from NQA

Home Path-Tec Earns ISO 13485 Certification from NQA

Safety and quality are paramount in the healthcare industry. Regulatory requirements have become increasingly important, and whether it is providing medical products, supplies, logistics, or technology, there must be a clearly defined quality management process to guide and maintain high standards across the board. Path-Tec has achieved certification for the ISO 13485:2016 standard pertaining to quality management systems in the medical devices field.

ISO 13485:2016 puts measures in place to standardize quality control, risk management, legal compliance, traceability and recall, process improvement, product improvement, and operational efficiency. Choosing Path-Tec as your specimen management partner provides you with unparalleled quality and unmatched peace of mind.

View ISO 13485 Certificate

Features & Benefits of ISO Standard

Meets Regulatory Requirements
Improves Efficiency
Meets Customer Requirements
Develops Quality Management System
Develops Professional Culture
Improves Product Quality
Controls & Manages Changes
Improves Communications
Improves Record Maintenance
Improves Consistency of Operations
Identifies Maintenance Requirements
Establishes Procedures to Validate Software
Increases Employee Morale
Creates Structured Planning
Increases Customer Satisfaction
Outlines Document Regulation Requirements
Reduces Waste
Monitors Supply Chain Performance
International Quality Recognition
Standardizes Company Processes

“ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.” (ISO, 2016).

References:
International Organization of Standardization. ISO 13485 – Medical devices. https://www.iso.org/iso-13485-medical-devices.html