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.
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 Development Tools
A turnkey solution for project and knowledge management in medical software product development. The Medical Device Project Management Kit is based on widely used tools.
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.
Product Development Health Check
The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements.
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.
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.
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 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.
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
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.
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.
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.
Etsimo: ISO 13485:2016 Quality Management System
Team Kasve built up together with Etsimo key personnel an ISO 13485:2016 QMS that, for example, enhances the company’s R&D activities, risk management and training of personnel.
Cerenion: ISO 13485:2016 Quality Management System
Kasve helped to build up ISO 13485:2016 QMS that, for example, enhances company’s R&D activities, risk management and training of personnel. Kasve also participated into software development documentation.
Blueprint Genetics: ISO 15189 – Quality Management System for clinical research laboratory
Team Kasve was responsible for building up a QMS to match ISO 15189 and US CLIA, Clinical Laboratory Improvement Amendments, requirements, and worked as an outsourced quality manager.