ISO 14001 Audits

Learn What FDA-Regulated Companies Need to Know About Environmental Compliance and Conducting ISO 14001 Audits

For many FDA-regulated companies, managing compliance is about much more than adhering to the laws and regulations that fall within the U.S. Food and Drug Administration’s (FDA) enforcement jurisdiction. Many FDA-regulated companies are subject to the oversight of other federal and international agencies as well, and many of these companies must also comply with standards enforced by their customers and commercial partners. Increasingly, this is including environmental standards—which frequently take the form of ISO 14001.

For companies that need (or want) to maintain an environmental management system (EMS) under the ISO 14001 framework, conducting periodic ISO 14001 internal audits is essential for measuring their efforts’ effectiveness and taking corrective actions.

At Oberheiden P.C., we help FDA-regulated companies and other clients conduct ISO 14001 audits for regulatory, commercial, and altruistic purposes. For companies that are subject to the FDA’s oversight, it is critical to ensure that their ISO 14001 environmental management systems do not create conflicts with their statutory and regulatory obligations. This includes, but is by no means limited to, obligations pertaining to control of non-conforming products, disposal of adulterated products and hazardous chemicals, and other operational activities that have potential environmental implications. With extensive experience both in the private sector and within the FDA (among other federal agencies), our lawyers and consultants offer our clients the insights they need to manage ISO 14001 compliance with confidence.

Key Focus Areas During an ISO 14001 Audit

As is the case with most other ISO standards, ISO 14001 focuses on providing guidance for developing an effective system rather than prescribing specific obligations and requirements. As the International Organization for Standardization explains, ISO 14001 “provides a framework for organizations to design and implement an EMS, . . . continually improve their environmental performance . . . [and] ensure they are taking proactive measures to minimize their environmental footprint, comply with relevant legal requirements, and achieve their environmental objectives.”

With this in mind, an ISO 14001 audit should focus on seven key areas (while also keeping in mind that ISO 14001 establishes dozens of individual standards within each of these seven areas):

• Context of the Organization – The context in which an organization operates is a key consideration for determining what is necessary in terms of an effective environmental management system. Examining an organization’s context, and how that context has changed over time (if at all), is critical for conducting an effective ISO 14001 internal audit. 
• Leadership – An ISO 14001 audit should confirm the company’s top-down approach to managing an effective EMS. If an audit does not confirm a sufficient commitment to environmental compliance at the leadership level, then there is work to be done. 
• Planning – Planning and structure are critical components of almost any ISO compliance program. This is certainly the case when it comes to implementing an EMS under ISO 14001. 
• Support – By adopting policies and procedures, companies seeking to implement ISO 14001 in a meaningful way must also provide adequate support for achieving the objectives of their EMS. An ISO 14001 audit will examine the support being provided and determine whether it is sufficient to achieve the company’s environmental goals. 
• Operation – Along with providing adequate support, companies must also ensure that they effectively implement their EMS in all pertinent areas of their operations. This is often a bigger undertaking than companies initially anticipate, and a comprehensive ISO 14001 audit will focus on determining whether a company’s implementation efforts have been effective. 
• Performance Evaluation – When it comes to assessing a company’s environmental impact and the effectiveness of its EMA, measurement is key. During the ISO 14001 audit process, companies must conduct performance evaluations focused on generating data that they can use to measure their EMS’s success. 
• Improvement – Continuous improvement is a core concept of ISO 14001. During the audit process, companies should evaluate not only the improvements they have made since their most-recent prior audit, but also whether they have adequate policies and procedures in place to facilitate improvement on an ongoing basis. 

Integrating ISO 14001 Compliance with ISO 9001 and ISO 13485 Compliance

Beginning in early 2026, medical product manufacturers and many other companies will need to come into compliance with ISO 9001 and ISO 13485. The FDA has adopted these standards under its new Quality Management System Regulation (QMSR). In many respects, ISO 14001, ISO 9001, and ISO 13485 are all designed to work in tandem; and, with the right approach and internal audit process, FDA-regulated companies can efficiently integrate ISO 14001 compliance into their QMSR compliance programs, if desired. Our lawyers and consultants are available to assist environmentally-conscious companies with this process—including conducting comprehensive audits focused on documenting the effectiveness of their environmental management systems while also establishing QMSR compliance for purposes of dealing with the FDA.

How We Help FDA-Regulated Companies with Their ISO 14001 Audits

Since we regularly assist companies with all aspects of FDA compliance, we are intimately familiar with the FDA’s requirements and expectations. We rely on this familiarity to help our clients make informed and strategic decisions not only regarding FDA compliance, but regarding their environmental initiatives and other areas of compliance as well. With this in mind, here are just some of the ways we help FDA-regulated companies with their ISO 14001 audits:

• We thoroughly evaluate the company’s environmental management system (EMS) under the framework and standards established by ISO 14001. 
• We help the company’s leaders and key stakeholders understand any shortcomings in its EMS, and we assist with implementing solutions for addressing these shortcomings efficiently. 
• We generate comprehensive documentation of the ISO 14001 audit process so that the company has a clear record of its environmental stewardship and can affirmatively demonstrate its ISO 14001 compliance initiatives to clients, customers, and other interested parties. 
• We assess whether the company’s environmental initiatives undertaken pursuant to ISO 14001 conflict or interfere with the company’s obligations owed to the FDA. 
• We assist with integrating the company’s environmental initiatives with its FDA compliance efforts (including its ISO 9001 and ISO 13485 compliance efforts) to ensure that they do not conflict or interfere with one another going forward. 
• We develop a regular audit schedule based on the company’s specific needs so that we can help the company and its leadership effectively manage all relevant interests on an ongoing basis. 
• We provide ongoing advice and consultation regarding all aspects of FDA compliance, ISO 14001 compliance, and all other areas of need. 

FAQs: Balancing Environmental Stewardship with FDA Compliance

Contact the FDA Compliance Team at Oberheiden P.C. to Learn More

If you would like to know more about our ISO 14001 compliance and audit services for FDA-regulated entities (and other companies), we invite you to get in touch. Call 888-680-1745 or contact us online to schedule a complimentary initial consultation at Oberheiden P.C.