ISO 9001 is the internationally recognised standard that defines the criteria for building a robust quality management system (QMS). The standard outlines a framework organisations can use to ensure their products and services are delivered to a high standard, consistently meet customer expectations, and comply with regulatory requirements. For digital health companies, achieving ISO 9001 certification ensures products and services are built on clear, detailed repeatable processes that consistently deliver high-quality results. Meeting the standard signals a commitment to maintaining a high level of quality, reliability, and in some cases, patient safety.

Although ISO 9001 is not always required for innovators selling into the NHS or launching their first pilot, our recent survey of digital health companies found that nearly 40% plan to achieve the standard next year. With that in mind, we’ve put together a comprehensive guide on ISO 9001; who it’s for, what it involves, its benefits, and the steps to take if you’re looking to demonstrate a commitment to quality.

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Why is ISO 9001 Relevant to Digital Health?

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While ISO 9001 isn’t industry-specific, it’s particularly valuable in sectors where consistent service delivery and proactive risk management are essential, nowhere is this more true than in digital health. In the UK, working with the NHS requires compliance with several standards, including DTAC, DCB 0129, and DSPT, which ensure the robustness, security, accessibility, and clinical safety of your digital health solution. However, these frameworks primarily focus on your product and don’t extend to your entire organisation. This is where ISO 9001 comes in.

ISO 9001 gives your organisation a clear framework for setting up processes and systems that ensure consistent quality and continuous improvement. It helps you manage risks that could affect customer experience or service delivery, whether it’s making sure patients have a smooth experience with your software or providing reliable support when buyers need help. As your organisation grows, ISO 9001 builds in the systems and steps needed to keep this level of quality steady, even as things become more complex.

Although ISO 9001 doesn’t typically form part of the regulatory requirements for digital health innovators working with the NHS, we’re seeing increased demand for this certification in the private sector. Many private healthcare organisations now request ISO 9001 alongside standards like ISO 27001, aiming to match the rigorous frameworks expected from NHS suppliers.

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But I’m in healthcare. Don’t I need ISO 13485?

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Not necessarily! ISO 13485 is crucial for organisations involved in the design, production, and servicing of medical devices. It has strict regulatory requirements focused on ensuring patient safety and compliance with medical device regulations.

However, if your digital health solution doesn’t qualify as a medical device, ISO 9001 may be a more appropriate fit. ISO 9001 provides flexibility, allowing you to tailor your quality management system to meet customer needs and industry standards without the strict regulatory requirements tied to medical devices.

Now, that’s not to say you should completely rule out ISO 13485 if you don’t have a medical device. Both standards are built on the foundation of ISO 9001, but ISO 13485 goes beyond by addressing specific requirements related to medical device regulations. By achieving ISO 13485, you'll also cover most of the requirements of ISO 9001 while adding an extra layer of compliance that could be beneficial, depending on how you’d like to continue developing your products or services. 

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What is the process of getting ISO 9001 certified?

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ISO 9001 is unique among the ISO 9000 series because it is the only standard that allows organisations to be certified against it. Like ISO 27001, achieving certification requires an external audit conducted by a certification body. The entire certification process includes:

Understanding the Standard and Gap Analysis: Begin by familiarising yourself with the ISO 9001 requirements and comparing them to your current processes through a gap analysis. This step helps identify any areas where your organisation’s Quality Management System (QMS) is lacking or needs improvement.

Developing your organisation’s QMS: Based on the gap analysis, you’ll need to update or develop your QMS. This involves defining quality objectives, documenting processes, and establishing procedures to monitor and improve quality across your entire organisation, not just your product.

Naq’s platform streamlines compliance with ISO 9001, from building your QMS to driving continuous improvement. If you're a digital health company, Naq ensures that the work you've done for other compliance frameworks, such as DCB 0129 and DTAC, contributes towards ISO 9001, saving you from doing the work twice. 

Need to upgrade to ISO 13485? Do it seamlessly with Naq's multi-framework management capabilities and manage all the compliance frameworks you need through one platform. Book a demo to find out more.

Employee Training and Awareness: Ensure all employees understand the QMS and their role in maintaining quality standards. This is crucial for fostering a culture of quality across the organisation.

Internal Audits: Conduct internal audits to check whether your QMS complies with ISO 9001 and identify gaps that need to be addressed before the external audit.

Management Review: Management reviews are designed to assess the QMS’s overall effectiveness. This includes reviewing internal audit findings, customer satisfaction, and progress toward quality objectives.

Corrective Actions: Implement corrective actions to address any non-conformities or weaknesses found during internal audits or management reviews.

External Certification Audit: This process usually involves a formal audit with a verified certification body. During the audit, the auditor will review your QMS documentation to ensure it meets ISO 9001 requirements.

Achieve Certification: If the auditor is satisfied, your organisation will receive its ISO 9001 certification. If any non-conformities are identified, you will need to address them before certification is granted.

Maintaining Certification: Certification requires ongoing maintenance. This includes regular surveillance audits to ensure that your QMS remains compliant, with full recertification typically required every three years.

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How long will it take me to meet compliance?

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The age-old question, and unfortunately, the answer is, it depends. The time to achieve ISO 9001 certification typically ranges from 4 to 6 months, depending on factors such as your organisation's size, the complexity of your operations, and the current state of your Quality Management System (QMS). If you're starting from scratch, you'll need to develop your QMS, implement necessary changes, and conduct internal audits before scheduling an external certification audit.

If you're opting to do it yourself, you’ll also need to account for the time it takes to fully understand the standard and its requirements. What’s really important, whether you're going the DIY route or working with external support, is to seek guidance from someone experienced with the standard before booking your audit. You don’t want to spend thousands on an external audit only to find non-conformities that could have been addressed beforehand.

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Effortlessly achieve & maintain ISO 9001 certification with Naq

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Naq streamlines over 70% of the ISO 9001 process by generating the documentation, policies, and controls needed to build your Quality Management System (QMS) and comply with the standard—at a fraction of the time or cost of traditional consultants.

For digital health organisations, Naq makes the process even easier. Since we already manage your healthcare compliance frameworks like DSPT, DCB 0129, and DTAC, adding ISO 9001 is seamless. Our platform validates your existing compliance work against new standards, reducing duplication, showing you exactly what’s left to do, and accelerating the entire process.

In addition to Naq’s platform, our customers gain access to a team of compliance experts to help navigate the complexities of ISO 9001. With our expertise, you can stay focused on innovation while we efficiently manage your quality management compliance.

Discover compliance without the complexity or the high costs. Book a demo with our team today to see how we can simplify your journey to ISO 9001 certification.

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