Quality Assurance

Focus On Quality

SRC has an unparalleled commitment to quality, continuous improvement, and regulatory compliance—implementing customer-focused quality management systems.

 

SRC is an ISO13485 certified company. We are compliant to the requirements of the Food and Drug Administration (FDA) for both Medical Devices and Pharmaceuticals, and are certified to the requirements of European regulations for CE (European Conformity) Marking.

Regulatory Compliance

  • Registered with the FDA as a Contract Manufacturer
    • Registration #1218347
  • Compliant to 21 CFR Part 820 Quality System Regulation
  • Certified to EN ISO 13485:2016 Quality System
    • Certificate Number FM 82720
  • CE certified for metrology—manufacturing of reusable, graduated, vaginal cream applicators.
    • Certificate number CE 80534
  • Product inspections based on ANSI/ASQC Z1.4:2003 sampling
  • Support to 21 CFR Part 210/211 with our Pharmaceutical customers

Customer-Focused

Our Mission is to meet our Customers’ expectation through Maintaining the Quality Management System as well as through the Products and Services we provide.

 

Our goal is to deliver quality products at competitive prices while providing outstanding customer service. We will work with our customers to bring an idea from a prototype to a finished product ready for ordering, manufacturing, inspection, and shipping phases. We are committed to meeting all customer requirements, insuring a successful outcome to all projects.

 

Our dedication, responsiveness, problem-solving, and sense of urgency are hallmarks of building long-term partnerships with our customers and suppliers.

Continuous Improvement

SRC utilizes a system-based approach to management and a risk analysis/fact-based approach to problem solving and decision making.

 

We take a process approach to manufacturing and conduct continual improvement to insure we exceed all quality objectives, including validations of the equipment process.

 

SRC takes great pride in our ability to do the job right the first time and have consistently maintained a facility-wide, less than 2% scrap rate for several years. This translates into cost savings for our valued customers.