ISO 9001 -standard

ISO 9001 is the globally well-known basis for effective quality management systems.

What is ISO 9001?

ISO 9001 is the internationally well-known basis for effective quality management systems. The standard sets requirements for the quality management system of an organisation and provides tools for building and developing a quality management system. This makes ISO 9001 a good foundation for various management systems (e.g. ISO 13485). Thanks to its international renown, the standard serves as a competitive advantage and a form of positive marketing.

Kasve’s specialists are experienced in preparing, updating and auditing several ISO 9001 quality management systems to ensure compliance with the standard. We will help you with designing your system, identifying and describing processes, development and auditing. Kasve’s specialists are qualified as lead auditors performing audits for ISO 9001 compliant activities.

Other standards

Environmental and occupational safety systems

Kasve can help companies to integrate the existing quality management system and the environmental and/or occupational safety system to be built into one functional management system.

Quality Assurance and Regulatory Affairs

Quality Management Systems in the Health Industry

Kasve will help you build a quality management system that suits your organisation’s operations and supports your business in the optimal way.

Software Life Cycle Management

eQMS

An efficient, easy-to-use and modern quality management system for a medical device manufacturer.

Software Life Cycle Management

Outsourced Software Development Project Manager

Kasve’s Software Development Project Manager ensures that your software development is proceeding with a goal-oriented and systematic approach.

Software Life Cycle Management

Product Development Health Check

The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements.

Software Life Cycle Management

IEC/EN 62304 Workshops and Training

The workshop involves presenting the main features of the product development of medical software and the IEC/EN 62304 standard to the extent that corresponds to the client’s needs.

Quality Assurance and Regulatory Affairs

Regulatory Affairs

With us, you will gain access to highly experienced specialists in regulatory affairs and their competence related to various regulatory challenges, such as obtaining a CE marking or FDA approval.

Quality Assurance and Regulatory Affairs

Outsourced Quality Manager

Using an outsourced Quality Manager or a person responsible for regulatory compliance will provide more flexibility and free your organisation’s resources to its core activities.

Quality Assurance and Regulatory Affairs

Quality Management System Audits and Evaluations

Kasve’s service range includes internal audits which help you conform to a specific standard, and evaluations and plans that enable you to update your system to meet new requirements.

Business Development

Outsourced Business Development Manager

Kasve enables its clients to prepare for entering the international market or expand their activities without a need to commit to permanent staff. Kasve’s clients gain access to a highly experienced specialist for the time and extent you need.

Looking for a quality expert?

We have helped a number of medicinal device manufacturers, testing and clinical laboratories, and start-ups develop their operations.

See our references

Quality Management and Regulatory Affairs

Software Development

Environment for medical software development to Migrevention

Migrevention is a digital headache clinic solution for patients, specialists, and clinics to manage migraine and other primary headaches. Kasve implemented a project with Migrevention in which an environment was created for the development of medical software.

Quality Management and Regulatory Affairs

With the help of Kasve, we developed a marketable medical device in a year

Together with Kasve, Nursie Health built a quality management system for their mobile application, which is a medical device.

Quality Management and Regulatory Affairs

Growth requires a quality management system

Nordic Laboratories did a preliminary study with Kasve for the clinical laboratory's quality management system, and is now building the quality management system itself.

Business Development

A comprehensive partner for the establishment phase

Kasve accompanied the preparation and establishment phase of Neurocenter Finland.

Business Development

We gained industry and business expertise to establish a new type of cooperation entity

Kasve supported the establishment of Kuopio Health by acting as project manager of the establishment project and as temporary CEO in close cooperation with the University of Eastern Finland.

Business Development

Additional drive to develop the startup business

Kasve has consulted Probitat in the development of a research-based startup business and i.a. in compiling sales and investor material.

Business Development

Led by Kasve, a leap towards a modern smart city

Together with Kasve, City of Kuopio carried out a business cooperation study for the Data Refinery project.

Quality Management and Regulatory Affairs

We launched the product as planned

Together with Kasve, Adamant Health built a quality management system on time to enable them to apply for the CE mark for their medical device.

Quality Management and Regulatory Affairs

Software Development

Kasve brought us enourmous Quality Management know-how

Together with Kasve, Kustannus Oy Duodecim has built a Quality Management System in accordance with the ISO 13485 standard, and is developing software product in accordance with the IEC 62304 standard.

Quality Management and Regulatory Affairs

Credibility for a Start-up with a QMS Certificate

Kasve supported Buddy Healthcare in building up the EN ISO 13485 compliant Quality Management System and developed company's internal auditing further.