Merivaara Quality
Continuous improvement and development of our operations
Merivaara, a forerunner in health technology and industrial design, focuses especially on innovative solutions that support operating room functions.
The prerequisite for our operations is the continuous improvement and development of our own work and know-how as well as of our other relevant stakeholders. We ensure the quality of our operations and professional service with the help of our competent personnel and carefully selected partners. We all are proud of the Merivaara quality.
Merivaara Oy’s management system has been prepared in accordance with the requirements of ISO 9001, ISO 13485 and ISO 14001. We are committed to complying the requirements including environmental protection and maintaining the effectiveness of the management system. The compliance of the system is regularly verified by internal and external audits.
Kiwa
Kiwa Inspecta is a world top 20 leader in Testing, Inspection and Certification (TIC). Merivaara’s quality and environmental management system has been audited and certified by Kiwa Inspecta.
EU Declaration of Conformity
In order to affix the CE marking the manufacturer or his authorised representative must follow the EC declaration of conformity procedure referred to in Annex IV of the Regulation (EU) 2017/745. This procedure must be completed prior to placing the device on the market.
The “EC declaration of conformity” is the procedure whereby the manufacturer or his authorised representative prepares the required technical documentation, puts into place corrective action and vigilance procedures and declares that the products meet the essential requirements set out in Annex I of the Regulation (EU) 2017/745.
ISO 9001
A general international quality management standard that forms part of a company’s quality assurance. It comprises all functions from product development to manufacturing and dispatch.
ISO 13485
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The standard has been set for planning, development, manufacturing and installation, as well as maintenance and repair of equipment classed as medical device.
The standard includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 14001
ISO 14001:2015 specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects. It applies to those environmental aspects that the organization identifies as those which it can control and those which it can influence. It does not itself state specific environmental performance criteria.