Quality Management System Audits and Evaluations

Auditing is used to assess how well an organisation’s quality management system is working.

Audit your QMS

Auditing is used to assess how well an organisation’s quality management system is working.

An audit involves reviewing the conformity of operations, instructions and evidence with set requirements. The aim is to develop operations by documenting any observations made during the process, monitoring the measures taken based on development suggestions and deviations, and the effectiveness of the implemented measures.

Kasve has a lot of experience in auditing different standardised quality management systems and performs internal audits for its clients.

Kasve also provides training related to auditing skills and performing audits. If your organisation already has a quality management system but aims to meet the requirements of a new standard, Kasve will provide you with an audit comparing your organisation’s current status with the new requirements and help you plan the steps towards certification.

Read more about our services related to the Quality Management Systems.

Our references

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.

Quality Management and Regulatory Affairs

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.

Quality Management and Regulatory Affairs

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.

Contact us

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Nina Vartiainen

Head of QARA

+358 50 367 1098

LinkedIn

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Rosa Tengvall

Lead Quality Engineer

+358 50 470 7220

LinkedIn

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Get to know the standards

IEC 60601 -standard

IEC 60601 is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment.

IEC 62304 -standard

IEC 62304 defines the set of processes for life-cycle management of medical device software.

ISO 13485 -standard

The ISO 13485 standard sets a frame for quality management systems for both medical device manufacturers and other organisations in the chain.

ISO 14971 -standard

ISO 14971 is a key risk management standard for medical device manufacturers.

ISO 15189 -standard

ISO 15189 is the quality management standard for medical / clinical laboratories, which places the patient care perspective at its centre.

ISO 17025 -standard

The ISO 17025 standard for testing and calibration laboratories describes the general and technical requirements for the competent, impartial and consistent operation of laboratories.

ISO 27001 -standard

ISO 27001 is an internationally well-known information security standard.

ISO 62366-1 -standard

IEC 62366-1:2015 describes the processes for a manufacturer of medical devices to analyse, specify, develop and evaluate the usability of the medical device as it relates to safety.

ISO 9001 standard

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

See more services

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

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.

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.

Business Development

Investor Materials and Due Diligence

Kasve has helped numerous companies draw up materials for investors. We also perform technical Due Diligence audits.