Company Quality Policy
The quality policy imposes that, in line with the Company mission, all processes are based on the rules of Quality Management System, according to UNI EN ISO 9001 standard.This system regulates the Organizational and technical activities applied to the entire corporate Organization in a systematic, planned, documented way and it is aimed at achieving the following goals:
- The continuous improvement of the process management methods for the achievement of better results, qualitative and quantitative;
- The achievement of a high level of effectiveness and efficiency regarding the production process, the Research and Development and Quality Control services and the services related to them;
- The extension and improvement of the range of microscope models (designed, produced and controlled), fully equipped and usable in various applications of Optical Microscopy.
The definition and planning of these objectives take place following an analysis of the context in which the Company operates, the needs of the stakeholders and the risks associated with its business.The achievement of such objectives is possible through the scrupulous and precise application of what is reported in the Company procedures, which define and describe the processes of the Quality Management System.
OPTIKA Microscopes is committed to pursuing the full realization and continuous evolution of the Quality Management System in order to consolidate and improve the Company image, also through the commitment and professionalism of all Company staff.
In order for the Quality Policy to be fully realized, the Organization undertakes to:
- Provide customers with products and services that are effective and compliant with the requirements set by UNI EN ISO 9001 standard;
- Describe the Company’s capabilities using the appropriate procedures and provide a product and service with quality assurance;
- Prevent damage that can be caused to people, things and environment;
- Guarantee the personal safety and training of its employees;
- Detect and examine non-conformities to improve the applied Quality System with appropriate corrective actions;
- Ensure that the requirements of UNI EN ISO 9001 standard are applied and maintained over time;
- Implement the Quality System to provide excellent product and service.
OPTIKA has been proudly achieved the ISO 13485 certification, an internationally recognized medical device quality management systems standard, which was awarded us for our design, development, manufacture and supply of microscopes for medical and diagnostic applications.
The ISO 13485 specifies the 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 and applicable regulatory requirements. We have developed and implemented our quality management system. Our decision to work towards the ISO 13485 accreditation demonstrates our commitment to providing high-quality and consistent products and services to our clients. The ISO 13485 certification is the assurance that we work according to the latest standards and regulations, also so that we can assure you as our partner that we have robust, clearly defined procedures in place.
Date: January 8th, 2020
Pietro Oliveri, CEO