Meet every requirement for
ISO 9001

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.

Establish a quality management system; Leadership commitment and a quality policy; Risk-based thinking throughout processes; Competence and resource management; Operational control, monitoring, and measurement; Continuous improvement through audits and corrective actions.

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: Small organisations: 3-6 months with dedicated focus and the right tools; Medium to large organisations: 6-12 months for full certification readiness. 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. See quality events and CAPAs↗.

Yes. Log non-conformities as they come up, assign an owner, link them to a CAPA and track each one through to closure, with evidence attached.

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.

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.

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.

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.

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.