Quality Policy
Shah Brothers is committed to timely delivery of quality products with full regulatory compliance. Our robust Quality Management System drives continuous improvement, while structured training programs enhance employee efficiency and satisfaction. We foster strong relationships with customers, employees, and suppliers upholding the values of respect and integrity in all our interactions
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ISO 9001:2015 certified
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ISO 146441-1 Class 7 cleanroom
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Quality Management system designed as per cGMP WHO Guidelines
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USP Class VII Compliant & TSE/BSE Free Components
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Sterility Assurance Level of 10⁻⁶ – Validated as per ISO 11137 for high-level sterility.
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Gamma Irradiated with Clear Product Labels and Gamma Indicator
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Double or Triple bagged components
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Complete Lot traceability of components
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Supplied Ready to Use Or Ready to Sterilize
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Robust Change Control in place – All process, design, and supplier changes are evaluated and documented.
Quality Built into Every Step
From sourcing globally trusted components to final cleanroom assembly and post-production testing, every step is governed by rigorous quality protocols. Our cleanroom environment, documentation control, and traceability systems ensure our customers receive products that are safe, consistent, and compliant—every single time.
Your Trust, Our Responsibility
We understand that the components we deliver are not just parts—they are vital contributors to human health, safety, and well-being. That’s why we don’t just comply with quality standards—we embody them. Our mission is to ensure that every assembly, every component, and every process upholds the trust you place in us, driving your success with zero compromise.
Certifications & Accreditations
Our business was founded on three main principles – quality, pricing and service – and we pride ourselves on our commitment to these principles each day. We provide outstanding quality to every customer and are here to ensure that all of your needs are met. Our commitment to quality is backed by certifications & accreditation by industry-standard bodies & organizations. Please find them below.
