Quality Management System

FlexBiosys Inc. has developed a Quality Management System (QMS) to standardize company procedures, continually improve product quality and customer satisfaction, prevent nonconformances, and improve profitability. The Quality Management System complies with the requirements of ISO 9001:2015 and as appropriate, the FDA Quality System Regulation 21CFR820. The QMS is fully defined, and includes processes related to:

QUALITY MANAGEMENT SYSTEM

  • General Requirements
  • Documentation and Records

MANAGEMENT RESPONSIBILITY

  • Management Commitment
  • Customer Focus
  • Quality Policy
  • Quality System Planning
  • Organization and Communication
  • Management Review

RESOURCE MANAGEMENT

  • Provision of Resources
  • Competence, Awareness and Training
  • Infrastructure and Work Environment

PRODUCT REALIZATION

  • Planning of Product Realization
  • Customer-related Processes – Order Processing
  • Design and Development
  • Purchasing
  • Production and Service Provision
  • Control of Monitoring and Measuring Devices

MEASURMENT, ANALYSIS AND IMPROVEMENT

  • Planning of Monitoring and Measurement
  • Monitoring and Measurement
  • Control of Nonconforming Product
  • Analysis of Data
  • Continual Improvement

What's New

We are proud to announce that as of June 15, 2017, our management system has been assessed and registered by Intertek as conforming to the requirements of ISO 9001:2015.

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