Quality Management Systems (QMS) Prevent Errors and Help Achieve Compliance for Healthcare Packaging
How can healthcare, pharmaceutical and medical device products manufacturers avoid packaging errors that can lead to patient harm and legal ramifications? A robust Quality Management System (QMS) for packaging is essential to produce safe and quality healthcare products.
QMS is Indispensable in Healthcare Packaging
The advantages of a robust QMS for healthcare product manufacturers include:
Minimization of Errors: Establishing standardized procedures and rigorous quality checks reduces the likelihood of packaging errors that could compromise patient safety.
Regulatory Compliance: Adherence to international standards helps avoid costly fees and penalties.
Transparency and Traceability: Detailed documentation and process monitoring that enables full healthcare supply chain traceability of materials and processes. This transparency is vital for regulatory audits and product recalls.
Consistency: QMS can standardize processes to create a uniform look and feel for your brands.
Packaging Suppliers with World-Class QMS
You shouldn’t have to stress over regulatory requirements and technical expertise. Your packaging provider’s QMS should be designed to help you achieve the best results:
Reduced Risks: Adherence to high-quality standards to minimize the risk of packaging defects.
Enhanced Efficiency: Streamlined processes meet tight production schedules.
Protected Reputation: High-quality packaging maintains your reputation for safety and reliability in the market.
With the right systems in place, you can focus on innovation and growth, knowing your packaging is handled by a true partner that prioritizes patient safety, compliance and quality.
How Certifications Help Your Business Succeed
Imagine having access to detailed documentation and traceability systems that help you sail through audits in minutes instead of weeks. ISO certifications ensure those processes are already in place and verified so that your packaging meets the stringent requirements of regulatory bodies, protects patients and gives you peace of mind.
• ISO 9001:2015: Certified manufacturing and fulfillment spaces that satisfy requirements through detailed documentation, process monitoring and communication of results.
• ISO 13485:2016: The quality management system standard for medical device manufacturers and suppliers.
• ISO 15378:2017: Standard for GMP compliance in medicinal products packaging.
• ISO 9008:2015: Specifies requirements for a QMS with a focus on risk-based thinking.
Additionally, current Good Manufacturing Practice (cGMP) certifications detail quality standards, including:
• GMI for process control validation
• G7 for color management expertise
• SGS, the global benchmark for sustainability, quality and integrity
• UL Authorized Label Supplier, meeting all the requirements of the UL quality assurance organization
With unique unit identification methods like barcodes, QR codes or RFID, it is easier to comply with the Drug Supply Chain Security Act (DSCSA) and simplifies your packaging compliance audits. This technology allows pharmaceutical products to be validated at all points in the supply chain where custody changes.
With RLG Healthcare’s sophisticated, certified QMS system, you gain a trusted partner dedicated to safeguarding your reputation, enhancing patient safety and ensuring compliance every step of the way. We collaborate with you every step of the way, reviewing the first article of each production process and every sequential step at quality control checkpoints. Have confidence in your packaging solution.
