ISO Internal Audit Compliance Specialists

Our Team Includes Non-Lawyer ISO Internal Audit Compliance Specialists Who Have Prior Experience at the FDA and Other Federal Agencies

If your company needs to conduct an ISO internal audit, you cannot afford to take chances. Noncompliance with applicable ISO standards can have significant financial and legal consequences—and, if your company is noncompliant, it needs to take all necessary remedial action promptly. At Oberheiden P.C., our team includes both highly experienced compliance lawyers and non-lawyer ISO internal audit compliance specialists. As a result, not only can we help you conduct an effective ISO internal audit, but we can help you determine (and take) your next steps as well.

Whether you need to conduct internal audits or you simply have questions about the process, audit checklist, or need help with your organization’s quality management system, we invite you to get in touch. We can explain everything you need to know, and we can help you feel confident that you are making informed and strategic decisions with your company’s best interests in mind.

5 Facts Most People Don’t Know About ISO Internal Audits

ISO audits are complicated. There’s simply no other way to put it. But, the challenges involved in conducting an effective ISO internal audit are not an excuse for failing to do what is required. To help you start making informed and strategic decisions, here are five facts most people don’t know about the ISO internal auditing process:

1. ISO Internal Audits Are Mandatory in Some Cases

While many business owners and executives know that conducting an ISO internal audit is an effective way of assessing the efficacy of their company’s compliance program, far fewer know that ISO internal audits are mandatory in some cases. For example, auditing compliance with ISO 13485:2016 is mandatory—and companies must conduct their ISO 13485:2016 audits in compliance with ISO 19011.

2. ISO Audits Can Be (and Should Be) Incredibly Detail-Oriented

All ISOs are extremely detailed, and this means that companies’ ISO internal audits need to be detail-oriented as well. When internal auditors are conducting an ISO internal audit, overlooking even a single relevant standard can result in a false affirmation of compliance in the audit report findings.

3. Documenting an ISO Internal Audit Is Just As Important as Conducting the Audit Itself

Companies don’t just need to conduct ISO internal audits—they need to be able to prove that they conducted these audits as well. When facing scrutiny from a federal agency like the U.S. Food and Drug Administration (FDA), companies that cannot affirmatively demonstrate compliance can face consequences that they could—and should—have avoided.

4. ISO Internal Audits Can Be Crucial Tools for Surviving Federal Audits, Inspections, and Investigations

In this same vein, ISO internal audits can be crucial tools for surviving federal audits, inspections, and investigations. The FDA and other federal agencies expect companies to be able to affirmatively demonstrate compliance—and ISO internal audit reports can be critical for this purpose.

5. Failing to Conduct an ISO Internal Audit (or Ignoring an Audit’s Findings) Can Have Serious Consequences

All of this means that failing to conduct an ISO internal audit can have serious consequences. The same is true of ignoring an audit’s findings. If your company needs to be prepared to demonstrate ISO compliance, you need a team of experienced ISO internal audit compliance specialists on your side.

Put our highly experienced team on your side

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

Why It Is Important to Work with an ISO Internal Audit Compliance Specialist

If you are like many cost-conscious business owners and executives, you might be thinking about conducting your company’s next ISO certification audit in-house. But, based on our experience representing companies that have taken this route, we can say confidently that this isn’t a good idea. Here are just some of the reasons why:

• ISO compliance can be extraordinarily complicated, and even ISO internal audits are subject to their own ISO standards (ISO 19011).
• If an ISO internal audit is not comprehensive, it won’t serve its intended purpose—and, if you thought your company’s audit was sufficiently comprehensive, you won’t know that this is the case. 
• Due to the complex and specialized nature of ISO compliance and ISO auditing, most companies lack the internal expertise required to manage these functions effectively. 
• As noted above, failing to spot (and remedy) compliance failures through the ISO internal audit process can have serious consequences—up to and including federal enforcement. 
• Working with an internal auditor from a team of experienced ISO internal audit compliance specialists can actually be the most cost-effective way to conduct an effective audit that protects your company, ensuring compliance. 

Why To Choose the ISO Internal Audit Compliance Specialists at Oberheiden P.C.

So, those are some of the reasons why it is important to work with a team of experienced ISO internal audit compliance specialists. Now, why should you choose to work with the specialists at Oberheiden P.C.?

• Our Specialists Worked at the FDA and Other Federal Agencies – Before entering the private sector, our Specialists worked at the FDA and other federal agencies. As a result, we have deep insights into these federal agencies’ expectations regarding ISO audits and compliance. 
• We Have Experience Working with Companies in Most Regulated Industries – Our experience is extremely broad. As a federal compliance law firm, we have worked with companies in most regulated industries, and we are familiar with the specific ISO standards that apply. 
• We Are At the Forefront of ISO Compliance – While many ISOs have been in place for years, the ISO landscape in the United States is undergoing changes. We are at the forefront of ISO compliance, including the FDA’s efforts to implement ISO 13485:2016 through its new Quality System Management Regulation (QMSR) taking effect in early 2026. 
• Our Team also Includes Experienced Federal Compliance Lawyers – Along with our ISO internal audit compliance specialists, our team also includes federal compliance lawyers who have also worked for several different federal agencies. As a result, beyond conducting ISO internal audits, we are also able to provide our clients with legal advice regarding federal ISO Compliance. 
• We Take a Comprehensive Approach to ISO Compliance – The breadth of our team’s experience allows us to take a comprehensive approach to assisting companies with ISO compliance. Once we complete your company’s ISO internal audit, we can review your audit findings and make sure you know everything you need to know to effectively manage ISO compliance on an ongoing basis. 

FAQs: What Business Owners and Executives Need to Know About ISO Internal Audits

Speak with an ISO Internal Audit Compliance Specialist at Oberheiden P.C. for Free

Are you interested in speaking with an ISO internal audit compliance specialist? If so, we encourage you to schedule a complimentary consultation at Oberheiden P.C. To schedule a call at a time that is convenient for you, give us a call at 888-680-1745 or tell us how we can reach you online today.