ISO 13029 is a guideline standard designed to help organizations implement a systematic approach to assessing and controlling risks associated with viral contamination during the manufacturing of biological products. It complements quality management systems like ISO 9001 and ISO 13485 and enhances the risk-based perspective in line with ICH Q9 (Quality Risk Management).
Biotechnological products, especially those involving mammalian cell cultures, are vulnerable to viral contamination, which may result in product recalls, health hazards, and regulatory penalties. ISO 13029 offers a globally accepted methodology to:
Implementing ISO/IEC 27701:2019 helps your business:
✅ Achieve GDPR and other global privacy regulation compliance
✅ Reduce data privacy risks through a structured, auditable PIMS
✅ Demonstrate commitment to data responsibility in B2B and B2C markets
✅ Build a competitive edge through trust and transparency
✅ Support digital transformation with strong privacy governance
✅ Attract clients and investors who demand high privacy standards
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