Certify Consulting Group
ISO 42001 implementation for companies that build or use AI, from AI and software vendors answering customer questionnaires to regulated manufacturers answering FDA and ISO auditors.
About
Certify Consulting Group is a US consultancy that helps organizations implement ISO/IEC 42001 and prepare for certification. We work with two kinds of client: companies that build AI into their products and are being asked by enterprise customers to prove it is governed, and companies that use AI inside processes a regulator or auditor already watches. For AI and software companies we build the AI management system alongside an existing ISO 27001 or SOC 2 program, including controls for model and prompt changes, data provenance, model providers and AI agents. For regulated manufacturers we build it into the ISO 9001, ISO 13485 or FDA quality system already in place. Engagements start with a fixed-fee ISO 42001 gap assessment covering every clause and Annex A control, followed by scoped implementation and certification audit preparation. Regulated sites can start with a fixed-fee review of AI-generated records and decisions. The practice is led by Jared Clark, JD, MBA, PMP, CMQ-OE, CQA, CPGP and RAC, certified in Computer System Validation, Computer Software Assurance and Pharmaceutical Validation Management, and also delivers ISO 9001, 13485, 14001, 45001 and 27001 readiness, FDA GMP compliance, R2v3 and ITAR programs. Remote across the United States. Fees and guides on cost, timeline, the Statement of Applicability, and ISO 42001 versus NIST AI RMF and the EU AI Act are published at certify.consulting.
Industry Specialization
Compliance Framework Expertise
Target Client Size
Regions Covered
Supported Languages
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