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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 NQA 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

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Path-Tec specimen management business logo

 
Path-Tec has been delivering innovative specimen and client management solutions since 2005, and we understand the challenges that laboratories encounter with their pre-analytical processes. Our client support solutions include supply and kit management, inventory management, specimen and supply logistics, and client management technology.

Tel: 706.569.6368
Fax: 706.569.6369
E-mail: customerservice@path-tec.com

 

ISO 13485 accreditation seal

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