Quality management at polysciences
Our Commitment to Quality is in Every Product and Process
Quality is formulated into everything that we do.
At Polysciences, Inc., excellence is our standard. We strive to exceed customer expectations through a steadfast commitment to Total Quality Performance.
Our approach to achieving this includes:
- Building strong customer relationships to understand and fulfill their needs effectively.
- Leveraging actionable quality metrics to measure and enhance performance.
- Embracing a “Right First Time” philosophy to ensure accuracy in every step.
- Maintaining a robust quality system to uphold the highest standards.
- Fostering a culture of continuous improvement through dedicated training and innovation.
By integrating these principles into everything we do, we ensure that quality is not just a practice but a promise to our customers.
ISO 13485:2016 Certification
This certification ensures Polysciences, Inc. operates under a compliant and robust Quality Management System, guaranteeing quality and reliability. Key elements include:
- Documented procedures and training to maintain clear guidelines and standards.
- Complaint management with corrective and preventive actions to address issues effectively.
This certification reflects our commitment to excellence in product development, production, and distribution.
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Food and Drug Administration (FDA) Establishment
Polysciences, Inc. maintains active FDA registration (#2518071), ensuring compliance with Current Good Manufacturing Practices (cGMP) under 21 CFR 820.
Key aspects include:
- Facility, methods, and controls for the design, manufacturing, packaging, and distribution of in-vitro diagnostic products.
- Safety and effectiveness of finished products, meeting the standards of the Federal Food, Drug, and Cosmetic Act.
This registration underscores our commitment to delivering safe, effective, and high-quality products.
Society of Chemical Manufacturers & Affiliates (SOCMA)
Polysciences, Inc. has been recognized by SOCMA for excellence in:
- Product Stewardship: Upholding the highest standards for product responsibility.
- Employee Training & Engagement: Fostering a well-trained and engaged workforce.
Through certification in SOCMA’s ChemStewards® Management System (CSMS), we demonstrate:
- Environmental, Health, Safety & Security (EHS&S): Exceeding standards in these critical areas.
- Commitment to Continuous Improvement: Achieving Tier III Excellence for surpassing EHS&S management benchmarks.
This recognition highlights our dedication to safe, sustainable, and globally competitive operations that support a healthy economy.
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QMS
Quality
Management
System
Robust ISO 9001:2015-certified QMS ensuring consistent product quality and customer satisfaction.
Certifications
ISO 13485:2016, cGMP-compliantmanufacturing capabilities, and REACH compliance.
Facilities
State-of-the-art facilities in Warrington, PA, and other global locations, designed for innovation and scalability.
Continuous Improvement
Regular process audits, employee training programs,and customer feedback loops to enhance operations and quality.
Compliance
Standards
Adherence to global regulatory requirements, including FDA, EU, and other international guidelines.
Contact Us for Quality Solutions
Have questions about our quality standards or need assistance with your specific requirements? Our team is here to help.
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