INSIGHTS & UPDATES

Why Medical Device Companies Need Annual Supplier Audits in China

January 2025 | Supplier Audits, Compliance

For medical device manufacturers relying on China-based suppliers, annual on-site audits are not just a best practice—they're essential for maintaining regulatory compliance and product quality. ISO 13485 and FDA QSR requirements mandate that companies maintain control over their supply chain, and remote monitoring alone is insufficient.

Key benefits of annual supplier audits include:

• Early detection of quality system degradation
• Verification of corrective actions from previous audits
• Documentation for regulatory submissions and inspections
• Building strong supplier relationships through direct engagement
• Identifying process improvements and cost reduction opportunities

Our cross-functional quality expert teams ensure comprehensive coverage across engineering, quality documentation, and warehouse operations—the critical functional areas where quality issues typically originate.

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Understanding ISO 13485:2016 Requirements for Chinese Suppliers

December 2024 | ISO 13485, Quality Systems

ISO 13485:2016 represents the global standard for medical device quality management systems. When your suppliers are located in China, ensuring ISO 13485 compliance requires more than reviewing certificates—it demands on-site verification of actual practices.

Common gaps we identify during supplier audits:

• Document Control: Outdated procedures being used on the production floor while current revisions sit in the quality office
• Change Management: Engineering changes implemented without proper ECN documentation or customer approval
• Traceability: Incomplete lot traceability chains, especially for raw materials and sub-components
• Calibration: Measurement equipment past due for calibration or missing calibration records
• Training Records: Operators performing critical operations without documented training verification

Our engineering-led audit teams identify these issues before they impact your product quality or regulatory standing. We verify that suppliers actually follow the systems documented in their quality manuals.

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GMP Compliance for Pharmaceutical Component Suppliers in China

November 2024 | Pharmaceutical, GMP, Compliance

Pharmaceutical and biotechnology companies face unique challenges when sourcing components and packaging materials from China. GMP (Good Manufacturing Practice) compliance is non-negotiable, and on-site audits are your primary tool for verification.

Critical areas for pharmaceutical supplier audits:

• Contamination Control: Cleanroom classifications, gowning procedures, environmental monitoring
• Material Segregation: Proper storage and handling of different product lines to prevent cross-contamination
• Batch Records: Complete and accurate batch production and control records
• Validation: Process validation, cleaning validation, equipment qualification (IQ/OQ/PQ)
• Supplier Qualification: Raw material supplier approval and ongoing monitoring
• Stability Programs: Proper stability testing protocols and data documentation

Our quality experts conduct specialized reviews of batch record systems and documentation practices, as well as material control and storage conditions—two critical areas where pharmaceutical GMP violations commonly occur.

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