ISO 13485 / 9001 Pre-Cert Mock Audit

ISO certification or recertification audit scheduled in 30–60 days? An external lead-auditor walks your QMS the way the registrar will. Full gap report. Written corrective-action plan. Optional retainer through the actual cert visit. By the day, not the engagement.

Quality Directors With a Cert Date on the Calendar

Built for the specific situation where you have an audit scheduled, a senior second-opinion would be useful, and your registrar isn't going to give you free advice.

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First-Time ISO Certification

50–500 person manufacturers preparing for first-time ISO 13485 or 9001 certification. The QMS is documented; you want a senior auditor to find what the registrar will find before they do.

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Surveillance / Recertification

Existing ISO-certified firms preparing for surveillance or recertification audits. New observations possible if processes have drifted; mock audit catches drift before the registrar does.

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New Quality Lead Recently Hired

Companies whose Quality Director or VP is new to the role and wants senior backup before walking into their first cert audit. Confidence boost + gap closure.

Lead-Auditor Credentials in Four Standards

Cross-standard experience means we can audit the integrated QMS holistically rather than treating each standard as a silo.

ISO 9001
Quality Management Systems
General quality management for any industry. Lead auditor at Scotsman (passed 9001:2015).
ISO 13485
Medical Device QMS
QMS for medical device manufacturers and suppliers. Lead auditor at Anatomy Supply Partners (US/China).
ISO 14001
Environmental Management
Environmental management systems audit. Cross-functional with 9001 in integrated QMS environments.
OHSAS 18001
Occupational H&S Management
Occupational health & safety management. Now transitioned to ISO 45001; legacy OHSAS support also available.

What the Audit Covers, What You Receive

Standard scope; adjustable based on QMS size and standard. Initial scoping call confirms exact day count and on-site / hybrid mix.

The Audit Itself

What I'll Walk

  • Pre-audit scoping call (1 hour, free) — confirm scope, day count, on-site vs. hybrid mix
  • 3–5 day on-site audit walking the QMS the way the registrar will
  • Document review: quality manual, procedures, work instructions, records
  • Process audits: design control (DHF / DMR / DHR), CAPA, supplier quality, training, internal audit, management review
  • Floor walks: production, inspection, calibration, non-conforming material control
  • Interviews with process owners across departments
  • Daily readback at end-of-day so you see findings in real time
What You Get

Written Deliverables

  • Full gap report against the applicable standard, with each finding categorized (Major / Minor / OFI)
  • Written corrective-action plan with prioritization and effort estimates
  • Document-level findings with reference to specific clause numbers
  • Process-level findings with recommended remediation steps
  • Executive readout deck for management review
  • Optional cert-day retainer: auditor available by phone during the actual cert visit

By the Day, Not by the Engagement

Day-rate model with clear scope. No retainer minimum. Optional cert-day retainer for live support during the actual audit visit.

Engagement Structure

Day-Rate · Scoping Call First

Day-rate model with clear scope. Quote provided after the free 1-hour scoping call.

  • Pre-audit scoping call (1 hour, free) — confirms scope, day count, on-site / hybrid mix & quote
  • 50% of estimated total on engagement; 50% on gap-report delivery
  • Travel and lodging billed separately at cost
  • Optional cert-day retainer available — auditor on phone during cert visit
  • Document control / template development scoped separately if needed
  • Senior auditor on every engagement — no junior auditor handoffs
Typical engagement: 3–5 days on-site mock audit + 2–3 days follow-up document and gap report. Multi-standard integrated audits scoped at the upper end. Exact pricing confirmed during the scoping call.

What This Engagement Does NOT Include

If your situation requires one of these, it's a separate engagement or referral.

Out of scope:

  • Internal audit program development. Building your internal audit program from scratch (training internal auditors, scheduling, audit planning) is a separate engagement.
  • ISO certification body fees. Those are paid directly to your registrar — I do not handle registrar selection, contracting, or fee processing.
  • Document control / template development. If your QMS documentation needs significant rewrite or new templates, that's scoped separately. Mock audit identifies the gaps; remediation is a separate engagement (or in-house effort using the gap report).
  • Quality system implementation from zero. If you don't have a QMS yet, you need an implementation engagement, not a mock audit. Refer to specialized QMS implementation consultants.
  • Acting as the cert auditor. I am NOT your registrar's auditor and cannot perform the cert audit itself. ISO requires independence between mock auditor and cert auditor; I'm the mock side.

Senior Lead Auditor. No Junior Handoffs.

One auditor walks the floors and writes the report.

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Mark Mayeux
Lead Auditor · QESaaS

Twenty-plus years in product quality engineering across medical devices, aerospace, and consumer goods. Director of Quality at Scotsman Ice Systems (Ali Group, 2016–2017) — passed major ISO 9001:2015 certification audit, multiple UL and FDA audits, plus extensive customer-led supplier audits from McDonald's, GE, and Viking. Director of Quality at Anatomy Supply Partners (2012–2015) — ran ISO 13485 across US engineering and China manufacturing operations; led post-acquisition integration of an ISO 13485 / 9001 registered China factory.

Lead-auditor experience across ISO 9001, ISO 13485, ISO 14001, and OHSAS 18001. Personally authored process documents and work instructions across full departments. Earlier in career: built the entire quality department at a medical equipment startup from scratch — including all agency documentation and supplier quality requirements — and the company was later acquired.

ISO 9001 Lead Auditor ISO 13485 Lead Auditor ISO 14001 Lead Auditor OHSAS 18001 Lead Auditor Six Sigma Supplier Quality Auditing Customer Audits Passed (McDonald's / GE / Viking) Med Equipment Startup → Acquisition

Before You Book

How far in advance should I schedule?

Ideally 6–10 weeks before your cert audit date. That gives 3–5 days for the mock audit, 1–2 weeks for gap report delivery, and 3–5 weeks for your team to close findings before the registrar arrives. Compressed timelines (less than 4 weeks lead time) accommodated; rate may adjust for expedited turnaround.

What documents do you need before the on-site visit?

Quality manual, top-level procedures, recent management review records, recent internal audit reports, and a list of process owners by department. Document review happens before the on-site visit so the on-site days are spent walking processes, not reading PDFs.

Can you sign an NDA?

Yes. A mutual NDA can be signed before any QMS documentation is shared. Standard one-page template available; custom NDAs accommodated.

Do you cover ISO 45001 (the OHSAS 18001 successor)?

Yes. OHSAS 18001 has been transitioned to ISO 45001. I cover both the legacy standard (for firms still operating against it) and the current ISO 45001 standard.

Multi-site audit?

Multi-site engagements available — typically priced at the higher end of the day rate plus travel between sites. Initial scoping call confirms approach (sample-site selection vs. all-sites coverage).

Do you do on-site or hybrid audits?

Standard engagement is on-site for the audit days; document review can be hybrid (remote document review + on-site process audits). Fully remote audits not offered for cert prep — the value is in walking the floor.

What if you find something major?

Findings are categorized as Major (would fail the cert audit), Minor (would generate observations but not a failure), or OFI (Opportunity For Improvement). The corrective-action plan prioritizes Majors first with effort estimates so you know what's achievable before the cert date. If the gap is too wide for your timeline, I'll tell you so on the readback rather than in the written report.

Book a Scoping Call

The 30-minute scoping call is free. Tell me which standard, when your cert audit is, and what your QMS looks like — I'll tell you whether the engagement is a fit and what it would cost.