From $1,600/day

Internal Audit Program

Internal
Audits

A qualified auditor from outside your organization runs your internal audit program, so the findings arrive before your registrar's or FDA's do, and the independence requirement is met without pulling your own people off their jobs.

"Keep it Simple. Keep it Real."

Book a Free Call 858-240-4353
From $1,600/day
Published price
Graded
Like a registrar
Every clause
Over the cycle
Jared Clark, Internal Audits consultant

What you get

An internal audit program that holds up at Stage 2

Registrars and FDA investigators read your internal audits to judge whether your system finds its own problems. A thin audit program is one of the most common findings we see. This is what replaces it.

A risk-based audit schedule

Every clause, process and shift covered over the cycle, with more frequent audits where the risk or the history says so. The schedule is the first thing an auditor asks for.

The audits themselves

On site or remote, against the standard and your own procedures, with records sampled, people interviewed and every finding traced to objective evidence.

Findings your team can act on

Each finding graded major, minor or opportunity, stated against the requirement, and written so the owner knows what to fix. No findings padded to look thorough.

Corrective action verification

We check the root cause and the fix on the next visit and close the finding only when the evidence shows it worked, which is what your registrar will check too.

How It Runs

Three steps

1

Plan

We review your last certification and surveillance reports, your previous internal audits and your open corrective actions, and build the schedule around where the risk is.

2

Audit

Each audit runs to a written plan with an opening and closing meeting. Findings are given in the room, so nothing in the report is a surprise.

3

Report and follow up

A written report within a week, entered into your CAPA system if you want us to, and verified at the next audit or before management review.

Scope

Standards we audit

ISO 9001, ISO 13485, ISO 14001, ISO 45001, ISO 27001 and ISO/IEC 42001 management systems, separately or as one integrated audit. R2v3 for electronics recyclers. FDA current good manufacturing practice for dietary supplements (21 CFR 111), drugs (21 CFR 210/211), food (21 CFR 117) and cosmetics, and the Quality Management System Regulation that brought ISO 13485 into 21 CFR 820 for medical devices in February 2026.

ISO standards require that internal auditors do not audit their own work. In a small company that often means no one inside can audit quality or production objectively. An outside auditor solves that, and also brings the view of someone who has seen how other companies, and other registrars, handle the same requirement.

If you are new to the standard, the consulting pages for ISO 9001, ISO 13485 and R2v3 explain what certification involves.

A good fit

  • Your certification or surveillance audit is within six months and the internal audit program is behind.
  • You are too small for your internal auditors to be independent of the processes they audit.
  • Your last registrar report criticized the internal audit program, or found things your internal audits should have found.
  • You run more than one standard and want one integrated audit instead of three.

Not the right service

  • –You want the certification audit itself. That is done by an accredited certification body, and we are not one.
  • –You want us to audit a system we built for you in the same cycle. We will tell you when independence requires a different auditor.

Price And Terms

From $1,600 per audit day

Every engagement is priced in writing after a free 30-minute call and before any work starts. On-site work is scheduled in full days; travel from Salt Lake City is billed at cost, with no markup, after the visit. You own every report and record we produce.

Most clients take a full annual cycle at a fixed fee, with audit days spread across the year. A single pre-certification audit is also available.

Frequently asked questions

What does an outsourced internal audit cost?

From $1,600 per audit day, including planning, the report and follow-up of corrective actions. Most small and mid-sized sites need two to four audit days a year to cover every clause and process; a full annual program is quoted as one fixed fee. Travel for on-site days is billed at cost.

Can an internal audit be outsourced under ISO 9001?

Yes. ISO 9001 clause 9.2 requires that audits are planned, carried out by objective and impartial auditors, and reported to management. It does not require that the auditor be an employee. Many small and mid-sized companies outsource the program for exactly the reason the clause gives: impartiality.

How often do internal audits have to happen?

The standards require planned intervals based on importance, risk and previous results, not a fixed number. In practice, every clause and process is audited at least once per certification cycle and the riskiest areas every year. We write the rationale into the schedule, because that is what the registrar checks.

Do you audit FDA GMP systems too?

Yes. FDA's drug and supplement regulations do not use the words internal audit the way ISO does, but an investigator who finds a problem your own quality unit should have caught will cite the quality unit. A GMP self-inspection program is the evidence that it is doing its job.

Will you use our forms and our CAPA system?

Yes. The audit records belong in your system, so we work in your templates and your software unless you ask us to bring ours.

Your Consultant

Who does the work

Jared Clark, our principal consultant, leads every engagement. He has spent his career in quality systems, FDA liaison work and regulatory affairs for pharmaceutical, dietary supplement, OTC drug, cosmetic and medical device manufacturers, and founded Certify Consulting in 2016. He holds the ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE) and Certified Pharmaceutical GMP Professional (CPGP) certifications, and has worked through certification and surveillance audits alongside NSF, UL, Intertek, SGS and ANAB-accredited registrars. His full credentials and their verification links are on the About page.

Related Services

Often paired with this one

Supplier Audits

On-site audits of your contract manufacturers and ingredient suppliers, with a signed report for your supplier file.

Mock FDA Inspection

We inspect your site the way FDA would and give you a mock Form 483 while there is time to fix it.

Fractional Quality Executive

A part-time senior quality and regulatory leader with regular site days, on a monthly retainer.

Get the internal audit program current

Book a free 30-minute call. Send your last registrar report if you have one, and we will tell you what the program needs before your next audit.

Book a Free Call Call 858-240-4353

Or email us at support@certify.consulting