Integrated EQMS for Plastic and Rubber Industry
Explore how the next-generation, AI powered EQMS integrates seamlessly with your workflows, enabling real-time tracking, root cause analysis, and data-driven decision-making. Whether you're producing food-safe plastics or automotive-grade rubber, we ensure your processes align with the highest standards for safety, sustainability, and excellence. With us, you gain the confidence to deliver excellence in every product and process.
Ensuring Quality and Safety Across Every Touchpoint
The Plastic and Rubber industry stands at the crossroads of innovation and responsibility, shaping everything from automotive components to medical devices. With rising regulatory demands, environmental sustainability goals, and complex supply chains, achieving excellence in quality, safety, and compliance has never been more critical. At Qualityze, we empower the Plastic and Rubber industry to meet these challenges head-on with cutting-edge quality management solutions. From ensuring material consistency and reducing defects to navigating standards like ISO 9001, REACH, and 21 CFR Part 820, we provide the tools and insights you need to deliver superior products while fostering sustainability and regulatory compliance. Let us help you create a resilient future for your business and the environment.
Video
The Qualityze Difference Empowers You To:
Ensure Material Consistency and Quality
Achieve product consistency by managing material variability in polymers, resins, and additives. Our EQMS provides real-time monitoring, centralized data management, and configurable workflows to ensure high-quality output, even with recycled or bio-based materials.
Achieve Precision in Manufacturing
Streamline extrusion, molding, and vulcanization processes with built-in quality checks and predefined templates. Our solution ensures tight tolerances and adherence to specifications for critical applications in automotive, medical, and other industries.
Mitigate Environmental Stress Cracking Risks
Leverage advanced analytics and monitoring tools to identify and mitigate risks of environmental stress cracking. Our EQMS enables proactive quality management to prevent failures caused by chemical or stress exposure.
Address Surface Defects Effectively
Proactively manage and reduce defects like sink marks, weld lines, or flash with automated defect tracking and root cause analysis. Qualityze EQMS helps you maintain the aesthetic and functional quality of your plastic and rubber products.
Streamline Compliance in a Complex Regulatory Environment
Stay ahead of emerging regulations, such as microplastic restrictions, while supporting sustainability initiatives like recycled content mandates and single-use plastic reduction. Ensure material traceability, manage waste effectively, and align with extended producer responsibility (EPR) frameworks to meet environmental and safety standards with confidence.
Enhance Product Reliability and Customer Satisfaction
Leverage robust quality workflows, automated testing, and centralized tracking to meet stringent safety standards and deliver superior products for critical applications.
| Standard/Regulation | Description |
|---|---|
| ISO Standards | |
| ISO 9001 | Quality Management System Requirements Applicable to All Industries, Including Plastic and Rubber Manufacturing |
| ISO 14001 | Environmental Management Systems for Sustainability and Compliance in Plastic and Rubber Production |
| ISO 45001 | Occupational Health and Safety Management Systems for Mitigating Workplace Hazards |
| ISO 13485 | Quality Management System Requirements for Medical Devices, Applicable to Plastic and Rubber Components Used in Healthcare |
| ISO 14971 | Risk Management for Medical Devices, Addressing Risks in Plastic and Rubber Components |
| ISO 11469 | Generic Identification and Marking of Plastic Products for Recycling and Traceability |
| ISO 1043 | Abbreviations for the Basic Polymers and Their Characteristics |
| ISO 177 | Determination of Migration of Plasticizers and Other Compounds in Plastic Materials |
| ISO 868 | Plastics and Rubber Hardness Testing for Material Consistency and Reliability |
| ASTM Standards | |
| ASTM D638 | Standard Test Method for Tensile Properties of Plastics |
| ASTM D790 | Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| ASTM D412 | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| ASTM D2000 | Classification System for Rubber Materials |
| ASTM F963 | Safety Requirements for Toys, Including Plastic and Rubber Materials |
| ASTM D395 | Compression Set Testing for Rubber |
| ASTM D573 | Heat Aging Testing for Rubber |
| FDA Regulations | |
| 21 CFR Part 177 | Indirect Food Additives and Requirements for Plastic Materials in Contact with Food |
| 21 CFR Part 175 | Adhesives and Components of Coatings in Contact with Food |
| 21 CFR Part 174-179 | Food Contact Substances and Specific Requirements for Plastic and Rubber Materials |
| 21 CFR Part 801 | Labeling Requirements for Rubber and Plastic Components in Medical Devices |
| 21 CFR Part 820 | Quality System Regulation for Plastic and Rubber Medical Components |
| EU Directives and Regulations | |
| EU REACH | Registration, Evaluation, Authorization, and Restriction of Chemicals Used in Plastic and Rubber Production |
| EU RoHS | Restriction of Hazardous Substances in Plastic Materials |
| EU 10/2011 | Regulations for Plastic Materials and Articles Intended to Come into Contact with Food |
| EU MDR | Medical Device Regulation for Plastic and Rubber Components in Healthcare Products |
| Environmental and Sustainability Standards | |
| ISO 14040/14044 | Life Cycle Assessment Standards for Analyzing the Environmental Impact of Plastic and Rubber Materials |
| California Proposition 65 | Regulation of Chemicals in Plastic and Rubber Materials to Ensure Safety |
| EPR Frameworks | Extended Producer Responsibility Mandates for Recycling and Waste Management of Plastic Products |
| GxP Guidelines | |
| GMP | Good Manufacturing Practices Ensuring Consistency in Plastic and Rubber Production |
| GLP | Good Laboratory Practices for Testing and Validation of Plastic and Rubber Materials |
| GDP | Good Documentation Practices for Accurate Record-Keeping for Materials and Processes |
| Automotive Industry-Specific Standards | |
| IATF 16949 | Quality Management Systems Specific to the Automotive Sector, Including Rubber and Plastic Parts |
| ISO 7620 | Guidelines for Vulcanized Rubbers Used in Automotive Applications |
| Testing and Performance Standards | |
| UL 94 | Flammability Standards for Plastic Materials |
| ISO 37 | Determination of Tensile Stress-Strain Properties for Rubber Materials |
| ISO 11357 | Differential Scanning Calorimetry (DSC) for Analyzing Thermal Properties of Plastics |
| Packaging and Labeling Standards | |
| ISO 11607 | Packaging for Terminally Sterilized Medical Devices, Applicable to Plastic Materials |
| ISO 19712 | Surface Materials Used in Plastics for Labeling and Identification |
Reasons to choose Qualityze EQMS for Plastic and Rubber Industry Industry
Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Plastic and Rubber Industry industry because it has
User-Friendly Interface
Simplifies usability with an intuitive design, requiring no technical expertise.Seamless Integration
Fits perfectly with your existing systems to enhance operational efficiency.Cloud-Based Platform
Provides secure, flexible, and anywhere-accessible data management.Automated Upgrades
Keeps you up-to-date effortlessly with automatic version upgrades.Configurable workflows and Fields
Adapts to your unique business processes with configurable options.Low Implementation Costs
Delivers a cost-effective solution without compromising on performance.Minimal Maintenance Needs
Eliminates hardware dependencies, offering easy access from any location.Flexibility and Security
Combines robust security with cloud-based flexibility to meet dynamic needs.AI-Powered Assistant
Offers intelligent support for proactive decision-making and streamlined workflows.The Start of Something Amazing.
Request Demo
Products
All Qualityze ProductsNonconformance ManagementCAPA ManagementDocument ManagementChange ManagementTraining ManagementAudit ManagementSupplier Quality ManagementComplaints ManagementCalibration ManagementMaintenance ManagementInspection ManagementPermit ManagementMaterial Compliance ManagementForms ManagementField Safety & Recall ManagementAdverse Events ManagementIncident ManagementRisk ManagementBatch Records Management8D Process
Industries
LifesciencesFood & BeveragesHealthcareManufacturingMedical DevicesPharmaceuticalsBiologicsBiotechnologyNutraceuticalsCannabisCompounded DrugsBlood & TissueAutomotiveAerospace & DefenseElectric VehiclePlastic and RubberElectronics and AppliancesChemical & AgrochemicalOil & GasEnergy & UtilitiesMetals & Mining
© 2025 Qualityze™ | All rights reserved. | Privacy Policy
