ISO 9001:2015 & Regulatory Compliance Integration Services
Seamlessly Align ISO 9001:2015 with Regulatory & Trade Requirements
Operating an ISO 9001-certified facility and navigating regulatory compliance? Our integration services bridge the gap between ISO 9001:2015 and regulatory frameworks, enabling you to meet all requirements without duplicating systems or documentation.
We help you:
✓ Harmonize ISO 9001:2015 with applicable regulatory and industry standards into one efficient system
✓ Simplify external audits and inspections through audit-ready documentation and protocols
✓ Navigate complex trade, import/export, and compliance requirements for global operations
Our Compliance Integration Services
1. ISO 9001 & Regulatory Alignment Program
-
• Perform a comprehensive gap analysis between your QMS and regulatory requirements (e.g., product safety, labeling, trade compliance)
• Create a unified documentation system that satisfies both ISO 9001 and regulatory expectations
• Integrate risk-based controls into existing QMS processes for seamless compliance
2. Inspection Preparedness
-
• Conduct mock inspections and audit simulations led by regulatory and certification experts
• Assist with corrective action responses to audit findings, regulatory citations, or notices
• Provide tailored inspection playbooks aligned with ISO 9001 and applicable regulations
3. Import/Export & Trade Compliance
-
• Develop and maintain supplier verification and import/export compliance programs
• Implement strategies to prevent customs delays and regulatory nonconformities
• Support documentation for cross-border trade and foreign market compliance
Service Options & Pricing
| Service | Description | Fee | Action |
|---|---|---|---|
| Basic Alignment | Documentation harmonization for facilities adding regulatory compliance | $4,500 | Subscribe |
| Full Integration | Comprehensive system alignment with team training | $10,000 | Subscribe |
| Trade Compliance | Import/export program development and documentation | $6,000 | Subscribe |
