INVISIO's commitment to quality is an essential ingredient of our culture and values with the overall objective of supporting our customers and users in their mission (and sometimes life) critical work-situations. Our commitment includes compliance to regulatory requirements in the countries we operate, and to meet the expectations of our customers and shareholders.
INVISIO complies with various regulatory requirements and standards, including the ones listed further below. INVISIO has developed a comprehensive Quality Management System, and works continuously to refine and improve this. The Quality Management System comply with international regulation and standards (e.g. ISO 9001) where requested by our customers and/or required by national/regional legislation.
Our commitment to Quality Management is reflected and deployed in many different areas. The following are 4 areas of special importance to INVISIO:
1. Product Performance and Reliability
Due to the critical situations, the users of our products are working under, the performance and reliability of our products and Systems are of our utmost concern. Consequently, we conduct comprehensive verification and validation test procedures and aim for the highest standards for product reliability by comprehensive reliability testing. Actual product performance in the field is monitored during the post market customer feedback process (as well as other results retrieved) and used for continuous improvements.
2. Customer Focus
INVISIO constantly strives to meet customer expectations i.e. through close dialog with customers (usually Large National Procurement Agencies) about their products/systems needs, perception and experiences from use. INVISIO strives to fulfil the implicit and explicit requirements/demands from our customers.
INVISIO strives to develop a culture and the required competences for all employees to actively take upon the responsibility and commitment to comply with company processes and constantly support the efforts to deliver products meeting our standards, as well as propose improvements to products and processes.
4. Continuous Improvements
INVISIO's Quality Management System covers all steps of our value chain from customer needs identification through Product Development, Industrialization, Supplier Quality Management, Receiving Inspection, Manufacturing, Final Inspection, Packaging, Shipping and Post Market Support/Service processes. We constantly strive to improve our business and monitor discrepancies and trends in order to define improvements. Internal and Supplier Auditing are also used to identify areas for improvements.
Regulatory requirements and Standards
INVISIO currently complies (amongst others) to the following approvals/certifications/authorizations:
• ISO 9001:2015
• MIL-STD-882E System Safety
• MIL-STD-810G Environmental
• MIL-STD-461F EMC
• DEF STAN 00-035 Environmental
• CSR - Corporate Social Responsibility
• CE-DoC documents: INVISIO X5, INVISIO T5, INVISIO V10, INVISIO V20, INVISIO V50, INVISIO V60
• CE-Doc document: Phonak