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Focalcube för kvalitetsstyrning - ISO 9001 - ISO 13485

Focalcube for quality management

Solutions for quality management | ISO 9001 | ISO 13485

Focalcube has been developed by experienced business developers. We are rooted in the medical device sector, where the demands for quality management are exceptionally high.

Focalcube’s features are tailored to build an electronic quality management system — an eQMS.

Your work with continuous improvements becomes both easy and enjoyable! Additionally, it simplifies certifications for standards such as ISO 9001 or FR 2000.

  • Focalcube för kvalitetsstyrning - ISO 9001 - ISO 13485
  • Quality management processes

  • Management

  • Customer focus

  • Quality policy

  • Roles, responsibilities and authorizations

  • Quality objectives

  • Competence and awareness

  • Infrastructure

  • Monitoring of resources, maintenance, etc.

  • Traceability in measurements, inventory numbers, etc.

  • Internal communication, news

  • Documented information

  • Product release, criteria, checklists

  • Handling of customer property

  • Customer complaints

  • Change management

  • Internal meetings, design reviews, management reviews

  • Supplier control and outsourced processes

  • Communication with suppliers and partners regarding changes and deviations

  • Labeling of non-conforming goods

  • Key metrics for planning and documenting the evaluation of process performance

  • Internal audits

  • Management review - standard input and output

  • Non-conformities and corrective actions

  • Continuous improvements

Make quality more fun! 🥳

Focalcube has been developed to simplify working with quality management standards such as ISO 9001 or FR 2000. The system includes modules for all aspects of the standard — everything from management and planning to follow-up is made easier with Focalcube.

When it’s time for a certification audit, it’s easy to identify what needs to be addressed, with all information gathered in one place — structured and organized!

Visual processes

With Focalcube Processes, you can create your own process diagrams, describe your processes, publish documentation, and manage tickets in a natural and clear way.

Powerful document control

With Focalcube, you manage your documents directly in the cloud. Features like access control, version management, electronic signatures, full-text search, automated numbering, metadata linking, and more ensure your documentation stays organized.

Electronic signatures and traceability

All critical decisions are signed electronically. An audit trail is maintained automatically, ensuring everything can be traced afterward.

Continuous improvements

Focalcube makes ticket management accessible to everyone. Issues and changes can be raised and prioritized immediately, ensuring nothing gets forgotten. As a quality manager, you can easily search for information and analyze trends. The system provides completely new opportunities to identify problem areas—a key factor in anchoring improvement projects.

Competence tracking

With Focalcube Training, arranging training sessions and following up with knowledge tests is simple. Naturally, it integrates with the system’s "read-and-understood" functionality.

Organized asset management

Focalcube Assets helps you manage all types of assets, such as machines, measuring instruments, IT systems, and delivered systems. Calibration schedules, service reports, and much more are simplified.

For all issues

With Focalcube, you can manage all types of tickets in the cloud, such as customer complaints, claims, change orders, internal process deviations, and environmental deviations. You can fully configure how the system is organized. Assign ticket owners to ensure nothing falls through the cracks. All tickets in one place—structured and organized!

Use Focalcube’s ticket module as a general ticket management system, deviation management system, claims system, or customer service/helpdesk system.

Everyone can participate

Focalcube makes it easy for everyone to contribute information—even external partners, customers, and suppliers. Advanced features like subscriptions, comment threads, and a personal to-do list make it simple for everyone to understand what is expected of them.

Access control
Access control

Users can easily be divided into groups to restrict access to items. Powerful configuration options make the work straightforward and transparent for those responsible for the management system. Access control in advanced modules, such as Focalcube Products, is naturally based on the information hierarchy that is established.

Comments
Comments

Each ticket includes a separate discussion thread, making it easy for colleagues, partners, and suppliers to comment ongoing matters.

Document management
Document management

For each ticket, you can upload and version-control attachments. Images, documents, and other supporting documentation are stored where they belong – within the ticket.

Export of tickets
Export of tickets

A ticket can easily be exported to Word format based on your custom document template. The ticket list can also be effortlessly exported to Excel for analysis and summaries.

Follow-up
Follow-up

Focalcube provides quick access to graphical summaries of, for example, tickets. Analyze the information from different angles to improve your operations based on trends and problem areas. You can also create automated KPIs in Focalcube Follow-Up.

Fulfils ISO requirements
Fulfils ISO requirements

Many of our customers are ISO-certified in quality and environmental management. Focalcube offers features that significantly simplify the certification process.

Full text search
Full text search

All objects in Focalcube are indexed by an advanced search engine, making it easy to find exactly the information you need.

Full traceability
Full traceability

All changes are logged with a complete history. The history enables restoring information and tracking changes during audits and inspections.

Focalcube naturally keeps track of all old document revisions. As an administrator, you can also prevent your users from accessing outdated revisions.

Integrated with other modules
Integrated with other modules

Tickets are a central part of Focalcube's other modules. Customer complaints, supplier issues, service tickets, and audit deviations are directly linked to their respective modules where they belong.

Portal for partners
Portal for partners

External parties can be invited to their own workspace, where they can continuously create tickets, participate in comment threads, and upload related information.

Powerful lists
Powerful lists

All lists are easy to overview and configure. Free-text search and advanced filters make it easy to find the right item. It's also simple to prepare a list of items to go through during, for example, a meeting. Additionally, all lists can easily be exported to Excel or PDF.

Reminders
Reminders

When ownership of an item is assigned to an employee, an automatic notification is sent. Ongoing reminders are issued for key events – for example, when a supplier needs to be evaluated, an external audit is approaching, a KPI value needs to be reported, or when a ticket changes status.

Smart linking
Smart linking

Focalcube's other modules are closely integrated with Focalcube Documents. This allows you to link, for example, a ticket or a meeting to a document. The documen — whose access is primarily controlled by the document collection's access settings — then also becomes available to users who have access to the linked objects.

Subscriptions
Subscriptions

Each user can configure their own subscriptions. When new tickets are created, notifications are sent to the relevant users. Naturally, owners and other stakeholders are informed when tickets are updated.

Team inbox
Team inbox

Focalcube can be connected to the team's inbox for incoming support. Incoming messages can easily be converted into new tickets. Ongoing email communication with the customer is managed directly from the ticket. Each employee can set up a personal email signature.

To-do list
To-do list

Too many tasks coming from all directions? Struggling to keep track of priorities? In Focalcube, all activities are gathered into a unified personal To-Do list. The system prompts you with reminders and helps you prioritize.

Work in multiple time zones
Work in multiple time zones

Users can easily set their time zone. All timestamps in the system are automatically adjusted to the personal time zone.