Quality Management System (QMS)
ISO 9001 is a recognised international standard for establishing, implementing, maintaining and improving a Quality Management System (QMS).
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We can assist you with all aspects of ISO 9001 including:
Create and centralise your quality manual, procedures and records. Apply templates, automate completion, set owners, due-dates and reminders; collaborate across functional teams.
Use smart, healthtech-specific ISO 9001 templates and guided workflows tailored to your organisation and product needs.
Monitor progress against ISO 9001 requirements in real time, with automated status tracking and smart dashboards to ensure ongoing compliance.
Maintain full control of documents and records with built-in version control and complete audit trails across every change.
Track and manage staff competence, training and awareness for all process owners and QMS stakeholders across design, production, distribution and servicing functions.
Built-in modules to support risk-based approach (required under ISO 9001), manage supplier documentation, track non-conformities, Corrective and Preventive Actions (CAPAs), and traceability.
Monitor quality performance in real time with automated alerts, audit tracking and incident management, ensuring issues are identified early and nothing is missed.
Streamline management reviews with automated workflows and a complete audit trail for every review and approval, ensuring total visibility, accountability and continual audit readiness.
Monitor quality performance in real time with automated alerts, audit tracking and incident management, ensuring issues are identified early and nothing is missed.
Work with our ISO 9001 and medical device quality experts who understand healthtech product development and can guide you in building and maintaining your QMS.
Invite auditors to securely review documentation and evidence directly within the platform. Reduce audit preparation time and keep all documentation, policies and controls organised in one place.
Use intelligent automation and AI to avoid duplication of work, easily meeting ISO 27001, ISO 13485, ISO 42001 requirements and many more.
Get in touch if we haven’t answered your question below, we are always happy to help!
ISO 9001 is the international standard for quality management systems (QMS). It helps organisations put consistent processes, clear responsibilities, document control, risk management and continual improvement in place to improve quality and customer satisfaction. ISO 9001 is suitable for businesses of all sizes, from startups and SMEs to large multi-site organisations, across sectors including software, healthcare, professional services, manufacturing and technology.
ISO 9001 addresses general quality management across industries; ISO 13485 is tailored specifically for medical devices, with additional requirements around regulatory compliance, traceability and device lifecycle controls. Many medical device companies choose to implement ISO 13485 alone, because it already incorporates many ISO 9001 principles. However, some organisations pursue both certifications to demonstrate broader quality capability beyond medical devices or to meet customer or sector-specific expectations.
Implementation time depends on organisation size and complexity:
Assuric accelerates implementation with pre-built templates, workflows, and dashboards for risk, supplier management, and process mapping.
Assuric helps organisations build, manage and maintain an ISO 9001 quality management system in one platform. You can create and control policies, procedures and records, assign owners, track actions, manage non-conformities and CAPAs, monitor training and competence, prepare for audits, and maintain clear evidence for certification. This reduces manual admin and makes ISO 9001 compliance more structured, efficient and scalable.
Yes. Assuric can help you build an ISO 9001 QMS from scratch using structured templates, guided workflows and expert support. This is useful for organisations going through ISO 9001 implementation for the first time, as well as teams replacing fragmented spreadsheets, folders and manual processes with a more centralised quality management system.
Yes. If you already have an existing QMS, Assuric can help you centralise, improve and modernise it. You can bring in your existing ISO 9001 documents, records and processes, improve document control, strengthen audit readiness, and manage quality activities such as CAPAs, supplier oversight and management review in one place.
Assuric supports controlled document and record management for ISO 9001 by helping you manage policies, SOPs, procedures, forms and quality records in one system. You can assign document owners, control versions, track approvals, schedule reviews, maintain audit trails and keep records organised and accessible. This helps support ISO 9001 document control requirements and reduces the risk of outdated or inconsistent documentation.
Yes. Assuric helps you manage non-conformities, corrective actions and continual improvement activities in a structured way. You can log issues, assign actions, track root causes, monitor deadlines, link evidence and maintain traceability through to closure. This supports CAPA management and continual improvement within an ISO 9001 quality management system.
Yes. Assuric supports both internal audits and external audit readiness by keeping documents, records, actions and evidence in one place. Teams can prepare for ISO 9001 certification audits more efficiently, maintain clear audit trails, respond to findings, and demonstrate that the quality management system is being implemented and maintained effectively.
Yes. Assuric can support multi-team, multi-site and multi-service organisations that need central oversight with local ownership. You can manage different departments, business units or operational scopes within one platform while keeping responsibilities, documents, actions and quality activities clearly organised.
Yes. Assuric helps reduce duplication by mapping ISO 9001 work to other frameworks and standards, including ISO 27001, ISO 13485 and ISO 42001. This allows organisations to reuse policies, controls, evidence and governance activities across multiple compliance programmes, making integrated compliance much more efficient.
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Kelly Klifa
CEO at Heim
Assuric has been transformative for Heim as we looked to achieve DCB0129 and DTAC compliance. The platform is easy to use, and the AI tools and automated reminders make previously dreaded compliance tasks a breeze. Paul and Matt supported us every step of the way.
Katie Baker
Director UK & Ireland at Tandem
Assuric has been fantastic in helping us quickly and safely navigate regulatory compliance in the UK. From completing Cybersecurity requirements to DSPT, DCB0129, and DTAC, the team was supportive, extremely knowledgeable, and the platform made everything quick and straightforward. A separate regulatory company we consulted at the beginning even remarked on how quickly we achieved compliance!
Maks Kozarzewski
COO at VitVio
We couldn't speak highly enough of both the Assuric team and the platform itself, which is incredibly easy to use, and with the skill and hardworking nature of the Assuric team. They've been a key component in accelerating our progress and deployments!
Maja Mazur
CEO at Healthnix
Assuric has been such a blessing in getting our DTAC and GDPR compliance done - completing all the documentation and deciding what needs to be done whilst running the business is very hard, but the team really helped us through that. The platform is easy to use, helps keep track of things and it even allows us to coordinate all the team training easily. Highly recommend them!
Dean Mawson
Clinical Director at DPM
Assuric streamlines the process of achieving and maintaining compliance with DCB0129 standards for digital health technologies. The user-friendly interface simplifies collaboration across multidisciplinary teams, while the built-in templates and workflows save significant time and effort during compliance projects. Assuric’s ability to centralise documentation and provide real-time visibility into project progress is particularly beneficial for Clinical Safety Officers and digital project teams, enhancing both efficiency and assurance.
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