ISO 9001 Quality Management System
Issued by ISO
StandardAudit Scope
Organization-wide quality management system. Process documentation, continuous improvement, customer satisfaction, management review.
What It Proves
Organization has implemented a quality management system that meets ISO 9001 requirements and passed a third-party audit.
What It Does Not Prove
ISO 9001 is a GENERIC quality standard — it does not include supplement-specific requirements. A packaging company with ISO 9001 has quality processes, but this says nothing about cGMP compliance. 'ISO Compliant' without specifying which standard is essentially meaningless.
How Vendors Report It
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