ISO 28000: Security Management Systems for the Supply Chain
January 1, 20261 min readReviewed by: Global Regulatory Affairs Team
Regulatory Guidance
This content is provided for educational purposes. Always consult official regulatory sources and qualified professionals for compliance decisions.
Overview
ISO 28000 specifies the requirements for a security management system, including those critical for the global medical supply chain. It addresses potential security threats at all stages of the manufacturing and distribution process.
Why It Matters
In the pharmaceutical and device sectors, supply chain security is synonymous with patient safety. ISO 28000 helps prevent:
- Diversion: Theft of high-value pharmaceuticals.
- Counterfeiting: Introduction of fake products into the legitimate supply chain.
- Tampering: Intentional contamination or damage.
Integration with GDP
ISO 28000 complements Good Distribution Practice (GDP) by focusing specifically on security risks rather than just quality/temperature risks.