ISO 45001 Audits

Our Federal Compliance Lawyers and Consultants Are Available to Assist with Internal and External ISO 45001 Audits

Many companies that are subject to the U.S. Food and Drug Administration’s (FDA) oversight choose to maintain ISO 45001 compliance. While not required for FDA compliance purposes, complying with ISO 45001 helps ensure that companies’ facilities are sanitary and safe, and it can help to minimize companies’ risk of facing workplace-related liabilities.

As with all areas of both FDA and non-FDA compliance, auditing is an important part of the ISO 45001 compliance process. Undergoing an external audit by certification bodies is required for ISO 45001 certification; and, even if a company isn’t seeking certification, internal auditing in the form of surveillance audits is an essential step for ensuring the efficacy of its ISO 45001 implementations.

We Provide Comprehensive ISO Management Systems Compliance and Auditing Services to Companies Throughout the U.S. and Around the World

At Oberheiden P.C., we provide comprehensive compliance and auditing services to companies throughout the U.S. and around the world. Our lawyers and consultants have experience helping companies implement and maintain compliance with numerous ISO standards, including the standards of ISO 45001. An internal auditor from our firm can conduct an internal audit to ensure that your company is prepared for its ISO 45001 certification audit, and we can assist with conducting efficient internal ISO 45001 audits on an ongoing basis to ensure that your company stays in compliance with all applicable standards and focuses on continual improvement.

About Our ISO 45001 Audit Services

ISO 45001 establishes management system standards for implementing an occupational health and safety management system. In this way, ISO 45001 is similar to the other ISOs with which many FDA-regulated companies choose to comply—including ISO 13485, which becomes mandatory under the FDA’s new Quality Management System Regulation (QSMR) effective as of early 2026. Like other ISOs, ISO 45001 does not establish specific requirements or criteria, but instead establishes standards around which companies are expected to build a framework that is custom-tailored to their specific risks and needs.

While this provides welcome flexibility (particularly in comparison to the many stringent rules and requirements with which companies must comply to pass FDA inspections and effectively manage other aspects of FDA compliance), it also presents some unique challenges when it comes to auditing. When auditing their ISO 45001 compliance programs, companies cannot simply use a checklist, but must instead rely on a certain amount of interpretation. They must determine how best to implement ISO 45001’s standards within the context of their operations, and then they must assess whether their chosen means of implementation are effective in serving their intended purpose. External auditors conducting ISO 45001 certification audits must make similar types of judgments as well.

Preparing for an ISO 45001 Certification Audit

This makes thoroughly preparing for an ISO 45001 certification all the more important for companies that want (or need) independent verification of the efficacy of their ISO 45001 occupational health and safety management systems. To help our clients prepare for ISO 45001 certification audits, we take steps including (but not limited to):

• Review of ISO 45001 Documentation – We review our clients’ ISO 45001 documentation, including their occupational health and safety management system policies and procedures, to determine whether they are sufficient to meet all applicable standards under the ISO. We do this as a preliminary first step, as any shortcomings in a company’s documentation will need to be addressed and corrective actions taken for the remaining steps in the process to be both efficient and effective.
• Occupational Health and Safety Management System Assessment – Once we have determined that our clients have all necessary documentation (and that they have implemented their documented policies and procedures within their occupational health and safety management systems), our next step is to assess the management system itself. This is similar to our internal ISO 45001 audit procedure, which we discuss below.
• Compliance Review and Next Steps – After assessing our clients’ occupational health and safety management systems, we then review our findings with our clients and outline their next steps. Depending on the circumstances, this could involve taking corrective measures before their scheduled ISO 45001 certification audit, or it could involve maintaining the status quo until the certification audit takes place.

Along with taking these steps (among others) to help our clients prepare for their external ISO 45001 certification audits, we also advise and represent our clients during the certification audit process. Our lawyers and consultants play an active, but non-intrusive, role in the process to ensure that the auditors correctly interpret and apply the relevant standards, and we work to proactively resolve any issues to help our clients efficiently secure ISO 45001 certification.

Conducting Internal ISO 45001 Audits to Maintain Compliance

Regardless of whether a company intends on maintaining ISO 45001 certification, conducting internal ISO 45001 audits is essential for ensuring that an occupational health and safety management system fulfills its role. Too often, companies invest in developing new policies and procedures, and then they gradually ignore them more and more until they are no longer of any use. This is a costly mistake from both a financial and risk management perspective, and it is a mistake that can—and should—be avoided with periodic internal auditing.

To help our clients effectively leverage their occupational health and safety management systems on an ongoing basis, we provide internal ISO 45001 audit services including:

• Assigning Roles and Responsibilities – We work with our clients to assign roles within their organization and within our firm so that appropriate personnel can leverage their relevant knowledge and insights during the internal audit process. Having an audit team with clearly defined roles and responsibilities also helps to facilitate efficient internal audits on an ongoing basis.
• Identifying and Cataloging All Relevant Documentation – We identify all documentation that is relevant to our clients’ ISO 45001 compliance efforts, and we catalog it so that the audit team knows where to find it. This, too, serves the dual purposes of ensuring that our clients’ internal ISO 45001 audits are comprehensive and ensuring that they are as efficient as possible.
• Thoroughly Evaluating ISO 45001 Compliance – With the necessary groundwork laid, we thoroughly evaluate our clients’ ISO 45001 compliance programs. Our lawyers and consultants rely on their intimate familiarity with ISO 45001 to interpret the relevant standards and apply them within the unique context of each client’s operations.

Here too, this list is not comprehensive. We design our internal ISO 45001 audit processes to be custom-tailored, efficient, and effective. When performed correctly, internal compliance audits drive value by helping companies maximize the return on their investments—while helping them proactively manage their risks along the way.

FAQs: Internal and External ISO 45001 Audits

Contact Oberheiden P.C. About Your Company’s ISO 45001 Audit Needs

To learn more about how we help companies manage ISO 45001 compliance, contact us today. Call 888-680-1745 orget in touch online to schedule a complimentary initial consultation at Oberheiden P.C.