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ISO 9001:2015 is the backbone of modern quality management. Its next revision explicitly incorporates AI integration for data analysis, process control and knowledge management. Our approach prepares you for that standard — not just for today's.

What you get by certifying with Tantia Consulting.
Four phases with clear deliverables and realistic timelines.
Thorough gap analysis against the target standard. Leadership and process-owner interviews. Evaluation of your current digital architecture.
Documentation development, team training, rollout of digital checklists and automated evidence from the Tantia platform.
Full internal audits with automated reports. Corrective action plan. Management review with live KPIs.
Support during the external certification body audit. Support on minor finding closure. 3-year recertification plan.
How AI is integrated specifically into this standard.
Tiered solutions based on the size and complexity of your company. Request a tailored quote.
For companies starting their certification journey with a focused scope.
For mid-sized organizations with cross-department processes and traceability needs.
For corporate groups or multi-site operations with ERP integrations and continuous compliance needs.
Between 4 and 9 months depending on size and initial maturity. With AI we cut documentation and internal audit time by ~40%.
We run a gap analysis and migrate what's usable. We don't rewrite; we modernize with digital components and automated traceability.
No. We are consultants. We prepare and support you during the external audit by accredited bodies (EMA, ANAB, UKAS).
Every sector applies the standard with its own nuances. Here are the main ones we've worked with.
Productive plants with complex processes and multiple lines.
Most relevant standardsTier 1, Tier 2 supply chain and OEM assembly operations.
Most relevant standardsFood production with COFEPRIS compliance and GFSI recognition.
Most relevant standardsMedical device manufacturers and labs with COFEPRIS/FDA requirements.
Most relevant standardsConsulting firms, IT, engineering and B2B services.
Most relevant standardsGo deeper with editorial content written by the Tantia Consulting team.
Clause 8.4 requires controlling suppliers and outsourced processes. An annual form no longer meets the bar. Here's what actually works.
Clause 8.5.2 requires identification and traceability. If you rely on Excel, you'll fail an automotive or pharma audit. Here's the replacement.
Clause 8.5.1 requires operational control. A well-written SOP is just the start. The next leap is automated recording from the ERP.
Book a no-cost diagnosis and get a clear roadmap.