Work directly with Onega Ulanova, an ISO 9001 consultant, IRCA-certified ISO 9001 lead auditor and former American Petroleum Institute (API) lead auditor with 16 years in quality management systems. She performs internal audits, gap assessments, QMS development, employee training, corrective action and certification preparation for small and mid-size manufacturers across the United States and internationally. Start with a free 20-minute consultation.
ISO 9001 clause 9.2 requires internal audits at planned intervals by auditors impartial toward the work they audit, and it permits you to outsource them. An external IRCA-certified lead auditor satisfies that independence requirement outright and delivers findings the way a registrar would, before your certification or surveillance audit. This is the most common reason manufacturers hire a consultant.
Deliverables: audit programme and plan, clause-mapped checklists with the evidence sampled, findings graded major / minor / opportunity for improvement, a written internal audit report usable as clause 9.2 evidence, corrective action requests with root cause guidance, effectiveness verification, and a management review input summary.
IRCA-certified lead auditor Onega Ulanova walks through the five ISO 9001:2015 audit questions small manufacturers stumble on most, traceability from purchase order to shipped part, documented process instead of tribal knowledge, calibration status of tools in use, who owns the quality management system day to day, and producing objective evidence on the spot. Video: youtube.com/watch?v=L16bCWSTtE4.
Twenty minutes, no charge, no obligation. You describe where you are, certified or not, what customer or contract deadline is driving this, and what exists on paper. You get an honest read on scope, effort and timeline, including the parts you can do yourselves, plus a short priority list of what to fix first. If we are not the right fit, we will say so.
Based in Ruston, in north Louisiana, serving manufacturers across the United States and internationally. Document review, QMS development, training, internal audits and certification preparation are delivered remotely over video, with on-site visits for process walkdowns and mock audits. If you are searching for an ISO 9001 consultant near you, industry audit experience matters more than drive time.
An ISO 9001 consultant assesses current practice against the standard, builds or reorganizes the quality management system around how you operate, trains your team, runs internal and mock audits, and prepares you for the certification audit, transferring ownership to your people.
Yes. Clause 9.2 allows outsourced internal audits, and an external IRCA-certified lead auditor guarantees the impartiality the clause requires.
At planned intervals covering every process and clause within the audit programme cycle. In practice annually, weighted toward high-risk and previously nonconforming areas.
No. Certification does not require a consultant. Most small manufacturers hire one because it is faster and avoids rework.
Cost depends on sites, headcount, existing documentation, and whether you need ISO 9001 only or also API Q1. Engagements are quoted as a fixed project or a defined block of hours, scoped on the free call.
Four to six months is realistic for a small manufacturer starting from little documentation, including one internal audit cycle, a management review, and Stage 1 and Stage 2 audits.
No. Certification audits must be performed by an independent accredited certification body. A consultant can run your internal and mock audits but cannot issue the certificate.
IRCA (International Register of Certificated Auditors) certifies auditors against defined competence and experience criteria; a lead auditor is qualified to plan and lead full QMS audits. Onega Ulanova holds IRCA certificate no. 6014255.