How NOTE ensures efficiency and ISO compliance with AM System

In Norrtälje, NOTE operates one of its twelve factories, where 170 employees ensure high quality and traceability in production. With customers in healthcare, aviation, and security, it is crucial to have a management system that guarantees structure and compliance – this is where AM System plays a key role.

As a publicly traded company and a contract manufacturer of electronics and complete products, the group NOTE operates within medical technology, industry, communication, and Greentech. With operations in six countries, the company offers production engineering services, series production, and aftermarket services.

At the Norrtälje factory, Niklas Andreasson is one of the leaders of the quality work. With over 25 years of experience at the company, he and his team of engineers ensure compliance with governing documentation, deviation management, and certifications.

Certified against ISO 9001, ISO 14001, ISO 45001 and ISO 13485

– What makes our work both stimulating and challenging is that we manufacture products with complex requirements for healthcare, aviation, and security. Our products must function even in demanding environments. We handle extensive requirements and are certified for ISO 9001, ISO 14001, ISO 45001, and ISO 13485, says Niklas Andreasson, Quality Manager.

AM System as a management system for many years

With AM System, NOTE has gradually built a strong and user-friendly management system where processes, documents, and cases are handled seamlessly.

"We had digital solutions early on, but AM System gave us something more – a structured and user-friendly platform."

- Each department now takes responsibility for its own processes, which has created strong engagement, explains Niklas Andreasson, Quality Manager at NOTE Norrtelje.

Multiple ISO certifications place high demands on traceability, revision, and control – with AM System, NOTE has created a clear structure that meets these requirements.

– AM System is our central tool for ensuring compliance with our ISO certifications. Here, we gather both governing documentation and case management, which gives us full control over our processes. We can easily track changes, manage versions, and ensure that deviations and improvement actions are followed up. The system allows us to meet our requirements and demonstrate regulatory compliance during audits, Niklas continues.

Easy for users to navigate and find

NOTE has created a structured and easily accessible workspace for all governing documentation and has built graphical process maps that allow users to quickly navigate and find the information they need. Features such as version history, revision reminders, and approval steps ensure that all documents are up to date.

"Employees learn the system quickly and can work independently. Thanks to clickable process maps and clear workflows, it’s easy to find the right information."

Case management is also an important part of the work. Here, deviations, changes, incidents, and improvement proposals are handled, with clear workflows for status and responsibility. Other examples include handling new projects, industrialization from prototype to series production, and purchase requests. Additionally, AM System is used to document and follow up on internal and external audits.

Creating engagement and participation

Today, AM System is considered a natural part of NOTE’s operations, and by allowing each process owner to take responsibility for their routines, they have created engagement in the system.

– From the very beginning, we let each department manager establish their routines and process maps, with the quality department as the approver. We have maintained this concept. New editions are constantly being created, which is necessary when we introduce new capabilities or improvements, says Niklas and continues:

"The flexibility of case management is another feature we appreciate."

- If we need to add or remove steps in a workflow, we can easily do so. As the company evolves, the processes in AM System need to follow suit.

Another aspect Niklas highlights is that AM System is also used across the NOTE Group.

– This facilitates our strong collaboration. We can exchange experiences and share templates for cases and documents.

Digitization as a strategic investment

At NOTE, digitalization is crucial for ensuring quality, traceability, and efficiency. They have long been at the forefront of using digital solutions and see it as a strategic priority.

- By gathering the entire management system on one platform, we've created better control and a clearer division of responsibilities. Everything is up-to-date and accessible, reducing the risk of errors. We also collaborate better within the organization and have smooth and systematic workflows. All this makes us more efficient.

Traceability is a central part of production and by collecting data and creating automated processes, we ensure that every step in production is documented and can be easily reviewed when needed.

- AM System is a natural part of our quality work. We wouldn't have kept it if it didn't work for us," concludes Niklas Andreasson, Quality Manager.

The key benefits of AM System

Today, AM System is a vital part of NOTE’s quality and management work. The system ensures compliance with industry requirements, maintains structure, and enables continuous improvements. Below, Niklas summarizes their three strongest benefits:

Three strong benefits of AM System

• Full control and compliance - Governing documents and cases are managed in a structured and traceable way
• More efficient workflows - Fewer manual processes and better collaboration between departments
• Customizable and scalable - Case templates and structures can be developed and adapted to specific needs