For manufacturers evaluating ISO certification for the first time, or assessing gaps before a customer deadline. This phase gives leadership a clear picture of where you stand and what it will take to get certified.

What we do:

• Conduct a structured gap assessment aligned to your target certification standard
• Brief leadership on readiness exposure, system maturity, and risk areas
• Evaluate existing documentation and process capability against clause requirements
• Define a phased implementation roadmap with realistic investment and timeline expectations

For manufacturers actively working toward certification. This phase builds the policies, procedures, documentation, and process controls your registrar will expect to see.

What we do:

• Align your system clause by clause to your target standard
• Develop documented procedures and operational standards
• Map processes and validate readiness through internal audit preparation
• Facilitate management reviews and provide hands-on implementation coaching

For certified manufacturers approaching surveillance or recertification audits. This phase protects the customer approvals and contract eligibility you have already earned.

What we do:

• Conduct independent internal audits using qualified lead auditors
• Validate corrective action root cause analysis and support closure
• Prepare your team for surveillance audit expectations and identify risk areas
• Provide on-site support during external certification audits

Tennessee MEP supports ISO 9001, AS9100, IATF 16949, ISO 14001, ISO 45001, ISO 50001, ISO 13485, and NQA-1 certification efforts. We also assist with additional quality, environmental, energy, safety, and industry-specific management system requirements. Contact Tennessee MEP to discuss a standard not listed here.

Timeline depends on your current system maturity and the standard you are pursuing. A manufacturer with no existing quality system typically needs 6 to 12 months for initial ISO 9001 certification. Manufacturers with existing systems pursuing additional certifications like IATF 16949 or AS9100 may need 3 to 9 months of additional work. Tennessee MEP provides a phased implementation roadmap during the initial assessment.

ISO 9001 is the international standard for quality management systems applicable to any industry. IATF 16949 builds on ISO 9001 with additional automotive-specific requirements including APQP, PPAP, FMEA, MSA, and SPC. Automotive suppliers typically need IATF 16949 to qualify as tier suppliers to OEMs.

Certification is not legally required, but it is often a practical requirement for doing business. Many OEMs, prime contractors, and regulated industries require suppliers to hold specific certifications. ISO 9001 is the most common across industries. AS9100 is required for aerospace. IATF 16949 for automotive. ISO 13485 for medical devices. Even without customer requirements, certification demonstrates quality discipline that opens new markets and reduces operational risk.

Cost depends on the scope, the standard being pursued, and your current system maturity. Tennessee MEP provides an initial consultation at no cost to assess your situation, define scope, and provide investment expectations. Engagements are project-based and scaled to your operation. Contact a Tennessee MEP Solutions Consultant for a specific estimate.