ISO Compliance: The What, Why, and How for Life Sciences Companies

    As a life sciences company, you play a major role in the overall global economy. Your products can be quite literally life-changing for the people you develop them for. Revenues in your industry are predicted to reach $1.5 trillion by 2020 and competition is getting fiercer by the year — so it’s no surprise that innovators and investors are pushing to be the first to market with their innovations.

    However, your products will never reach patients if you fail to meet FDA Regulations or achieve ISO Compliance and the regulatory bodies label your products as ineffective or not safe for human use.

    Noncompliance or failure to uphold quality standards can result in your products being recalled, your company’s reputation being forever tarnished, and large sums of revenue being lost.

    There are two main regulators that impact most life sciences companies, the U.S. Food and Drug Administration (FDA) and the ISO International Standards. Depending on where you are distributing, you could find yourself required to comply with both organizations if you want to bring your product to market.

    Today, we’re going to cover the basics of ISO (pronounced "eye-so") compliance. Even if you aren’t required to be compliant at this stage of your company, it’s important to at least be aware of what it is and be prepared. If you follow ISO standards, your company will be able to focus on quality and move to the top of your industry.

    What Is ISO Compliance?

    When your company is deemed ISO compliant, that means that you have successfully met the standards for quality issued by the International Organization for Standardization (ISO). They chose the "ISO" to standardize their name across different languages and derived it from the Greek isos, meaning equal.

    Headquartered in Geneva, Switzerland, ISO describes themselves and their purpose:

    “Whatever the country, whatever the language, we are always ISO (equal). ISO is an independent, non-governmental international organization with a membership of 164 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges.”


    The standards laid down by ISO are designed to ensure that products, systems, and services are produced in a high-quality environment designed to ensure safety and efficiency. There are over 22,000 International Standards and related documents that address nearly every industry.

    Why Should We Be ISO Compliant?

    ISO is optional only in the U.S. However, if you are going to market outside the U.S., ISO regulations apply, and you will need to seek ISO compliance.

    Even if you’re only planning to market to the U.S., being familiar with ISO regulations and choosing to implement some of them in your business can still be a good thing to consider.

    For small to medium enterprises (SMEs), the standards issued by ISO can actually help you in several ways.

    • Customers will be more confident that your products are safe and reliable.
    • You can meet the requirements of regulations at a lower price point.
    • Costs will be lower across all aspects of your business.
    • You’ll gain access to a wider worldwide market.

    How Do We Get (and Stay) ISO Compliant?

    If you’re interested — or required — to seek ISO compliance, then it’s important to first understand that ISO compliance isn’t a blanket process. You will have to become compliant in the specific standards that are applicable to your industry and product.

    It’s also important to understand the difference between ISO compliance and ISO certification.

    ISO compliance indicates that you strive to meet the standards internally and perform audits to ensure standards are upheld.

    ISO certification means that you have demonstrated your compliance to an auditor from a certification body. They audit your company, ensure your compliance, and then issue your certification.

    For the sake of this article, we’re going to address two of the most common standards that impact life sciences companies and their Quality Management Systems (QMS), ISO 13485 and ISO 9001.

    ALSO SEE: The Essential Parts of an ISO 13485 Medical Device Quality Management System

    ISO 13485 vs. ISO 9001

    Most companies will choose between ISO 13485 and ISO 9001 instead of choosing to become compliant in both. However, if you are in a situation where medical devices are only a part of your business, then you might want to be certified in both.

    Both regulations address the same common goals:

    Consistency: They strive to help companies consistently create safe, high-quality products that meet customer expectations.

    1. Risk: They encourage companies to include risk in their design and production.
    2. Process: Both standards utilize the Plan-Do-Check-Act approach.
    3. QMS: They also require that you have effective process and tools for compliant document management, corrective and preventative action (CAPA), and employee training.

    There are some key differences between ISO 13485 and ISO 9001:

    Emphasis: ISO 13485 focuses on the safety and efficacy of your medical devices while ISO 9001 focuses on customer satisfaction.

    1. Ongoing Responsibilities: ISO 13485 only requires you to demonstrate effective implementation and ongoing maintenance of your quality system where ISO 9001 wants you to show continuous improvement.
    2. Compliance: ISO 13485 has more strict documentation requirements, the ability to demonstrate risk management principles, and address the requirements for complaint handling and post-market feedback.

    Many manufacturers that are selling devices internationally are currently choosing to drop the ISO 9001 for the ISO 13485 because ISO 13485 is in the process of being adopted as the standard by many global regulatory agencies.

    RELATED READING: An ISO 13485 Risk Management Plan Example You Can Steal and Use

    The Role of an eQMS in ISO Compliance

    If you seek ISO compliance, an industry-specific, compliant-focused enterprise Quality Management System (eQMS) software is a critical component for your ongoing success.

    Effective medical device manufacturing quality management is an exhaustive series of multiple steps, information overload, and never-ending documentation. Don’t track all of your valuable compliance data in employee’s brains, paper notes, and overflowing file cabinets.

    The Qualio eQMS is specifically built for small and growing life sciences companies with 5-500 employees. We've worked hard to make ISO 13485 compliance as simple as possible for medical device companies.

    Without Qualio, we would not have been able to achieve our critical milestone of ISO 13485 certification before the end of the year. We are now prepared to take the next steps towards compliance with European regulatory requirements and the CE mark. — Jonas T., Quality Manager


    To see how our platform can make ISO compliance and certification attainable for your organization, schedule a demo.

    How Hard Will it be to Become ISO Compliant?

    ISO compliance can be achieved in as few as three to six months — if your systems and process are already focused on high-quality manufacturing.

    If you’re not sure how close you are to compliance, take our free self-assessment to get your own personal quality score; don’t worry, your score is completely private.

    Our self-assessment tool will let you see how well you are doing and identify areas for improvement.