ISO 9001 Quality Management System

Defined by ISO publishes the standard; certificates are issued by accredited certification bodies

Standard

Audit 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. IAF CertSearch participation is voluntary: absence from the database does not prove a certificate is invalid.

How Vendors Report It

You may see this listed as:

ISO 9001:2015ISO 9001ISO Compliant

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Vendors Listing This Certification

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Related Certifications

Current Good Manufacturing Practice (cGMP)

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