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Digital health technology companies have a great deal to gain by investing in ISO 9001 compliance - even if it's not mandated.
For businesses entering a highly fragmented and competitive healthcare technology market globally, ensuring business processes follow consistent approaches can be the difference between scaling successfully and being left behind by more professional competitors. In this blog, written by our Managing Director Kasia Kaczmarek and process master at 8fold, we’ll unpack why early-stage companies should be looking to ISO 9001 as an enabler and not a blocker to success.
BS EN ISO 9001:2015, commonly referred to as ISO 9001, is a universal Quality Management System (QMS) Standard that is recognised internationally. It helps an organisation create a structure to improve its overall performance and provides a foundation for development and continual improvement.
According to the International Organization for Standardization, 1,077,884 million ISO 9001:2015 certificates were issued globally in 2021 – of which 13,807 certificates were issued in the ‘Health and Social Work’ Sector. Out of these, 218 were issued to businesses based in the United Kingdom and Northern Ireland.
Compliance framework
As a heavily regulated industry, digital health products are likely to require some level of compliance whether this is nationally or customer-specific. As a Quality Management System, ISO 9001 can help companies establish a framework for managing policies and procedures in an efficient and effective way.
Clear responsibilities
ISO 9001 requires an organisation to establish clear responsibility, accountability and reporting, reducing miscommunications and the inefficiencies and errors that come with poor organisational structure.
This can also help founders and senior managers to effectively delegate work and responsibilities to their teams – freeing up time for more important tasks.
Managing Risk
Providing a comprehensive framework for Risk Management across the business ensures organisations are prepared for disruptions.
Continual Improvement
Implementing effective actions to prevent the occurrence or recurrence of non-conformities prevents the organisation from making the same mistakes over and over again.
Recognisable certification
ISO 9001 can be certified by an external party, giving confidence to customers that it has been effectively implemented but be sure you pick the right certification body – you can learn more about this in our latest blog: “Understanding ISO Standards and Certifications”.
Many developers of health technologies use ISO 9001 to give their businesses structure, consistency and quality and to give reassurance to their customers – although Medical Device manufacturers will want to look at ISO 13485 as a Medical Device-specific, mandatory Quality Management System standard. Clinical services, care homes and community health service providers also often follow ISO 9001, so it will be recognised as something your customers are aware of.
At the core of the ISO 9001:2015 standard lies a focus on well-led, risk-based, and customer-centred delivery of high-quality services, which are fundamental principles in the health and social care sector.
Outside of the Digital Technology Assessment Criteria (DTAC), the rationale for obtaining ISO 9001:2015 certification is that it serves as a framework for establishing policies, procedures, and effective monitoring and measurement. Health tech suppliers to the NHS face the challenge of meeting ever-changing and increasingly demanding statutory, regulatory and NHS-specific requirements, while also competing for commercial opportunities with other providers.
While ISO 9001 is not currently a mandatory requirement for health tech companies that are looking to do business with the NHS, health tech startups and SMEs can benefit from ISO 9001 certification – the real question is; without it, how can the business promote its maturity? How can it provide reassurance to customers and tenders that it can deliver quality products or services that meet the requirements laid out by customers? And, how can it legitimately compete for business with competitors that have much deeper pockets?
- Design a Quality Management System that suits your business – buying off-the-shelf templates will often lead to mismatches with your business’s unique needs. You’ll need someone with previous experience with ISO 9001 Quality Management Systems to advise you in doing this.
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Implement and Educate – you need your staff and key stakeholders to understand their roles and responsibilities and how they interact with your Quality Management System. You also want to make sure that staff have the tools and knowledge to follow what has been laid out.
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Certify – An external party (a Certification Body) will perform an audit of your Quality Management System – a thorough review of your documents and evidence of you following them. Following a successful outcome, they will provide you with your certificate.
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Maintain – A Quality Management System is for life, not just for Christmas (or audit day) – to get the most out of it, you’ll want to be following the requirements you put in place day-to-day. Not to mention, your Certification Body will be coming back each year to check up on you.
For more information about what ISO 9001 certification involves and how 8fold can empower your journey to compliance, check out our IS0 9001 service.
Combining Standards
Combining multiple standards keeps your costs down and reduces the number of days required to audit and assess your Quality Management System each year. Book a no-obligation discovery call and speak to our ISO expert about:
- ISO 13485 – mandatory for Medical Device manufacturers.
- ISO 27001 – covers Information Security Management.
- ISO 42001 – Management of AI systems.
Summary
Whilst ISO 9001 is not an essential standard for digital health businesses to adopt, the advantages of developing a quality management system are obvious. By building a strong foundation to base critical business functions this is proven to expedite scale, inspire trust and set businesses apart from the competition.
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