The Measures and Mindfulness to Ensure Quality.


BSI-KiteMark-13485-2OPERON is ISO 13485:2003 Certified
ISO 13485:2003 is an internationally recognized quality standard that specifies the requirements for a Quality Management System (QMS) for the design and development, production, installation and servicing of medical devices and the provision of related services. Based on ISO 9000, this Standard is aimed at ensuring the quality, safety, and efficacy of medical devices. Operon Resource Management is the only known staffing firm certified to ISO 13845.

At Operon, quality begins with an internal commitment to integrity, excellence, and a genuine concern for those we serve, from clients to job candidates to our clients’ end-users. Operon can guarantee medical device and health care product manufacturing clients that all our associates are screened and trained in compliance with the stringent quality requirements established by the ISO 13485 Standard.

Our commitment to quality is guided by the following core principles:


To be one of the primary reasons that best-in-class healthcare product manufacturing companies can stay and thrive in America.


To provide immediate and continual value for our clients by reducing total labor costs while increasing quality & compliance through the continuous pursuit of workforce processes and productivity enhancements.


  • Honesty, Integrity & Respect
  • Quality & Excellence
  • Team Dedication
  • Commitment
  • Reputation
  • Innovation


Like you, we also employ a host of best practices, protocols and systems to enhance and optimize our job performance. These include the mandatory use of E-Verify for every new hire, our own On-Site Management System, internal audits, Kronos, and other industry-leading technology for managing data, records, and billing.

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Quality Management System

Operon employs an internally developed, web-based Quality Management System that all Operon personnel must use when performing defined business processes. With its intuitive interface and easy navigation, users have quick access to all client-specific procedures, work forms, and other documents. Every work instruction or SOP is clearly outlined to facilitate consistent execution of The Operon Gate and to ensure the clear understanding of our client’s procedures among our entire Operon staff, from site to site, and coast to coast.

Quality Assurance