Certifications and Documents
Quality is one of the main pillar of VISIA LAB
A multidisciplinary team, which involves experienced quality and regulatory personnel in every phase of the project, is the key to obtaining technologically advanced, safe and effective products, which satisfy the customer from all points of view: qualitative, technical and compliance with current regulations.
The training and constant updating of personnel are strategic activities and essential conditions for the achievement of continuous improvement within the company and for the achievement of quality objectives.
Each employee is involved, motivated and sensitized in order to ensure the highest level of excellence in the execution of the relevant process phases.
Downloads / Documents
Organisational Model 231
Visia Lab S.r.l. adopted, on March 26, 2024, an Organization, Management and Control Model pursuant to Legislative Decree 231/2001, which introduces the administrative liability of companies for certain crimes committed in the interest or to the advantage of the entity by senior or subordinate subjects.
Decree 231/2001 was created to implement international conventions against corruption and provides that the entity can be exempted from liability if it adopts an organizational model suitable for preventing crimes.
The Visia Lab Model is composed of:
- General Part, which illustrates the Decree, the structure of the model, the disciplinary system, the Supervisory Body and the methods of dissemination of the Model;
- Special Part, which analyses the sensitive processes and defines the behaviours to be adopted to prevent crimes;
- Preliminary analysis and risk assessment;
- Catalogue of relevant crimes pursuant to Legislative Decree 231/2001;
- Gap Analysis.
The Model aims to prevent crimes and ensure regulatory compliance and ethical responsibility within the company.
The entire General part of the Organizational Model is available at the following LINK
Certifications
For the European market, our products are CE IVD marked according to current regulations and tested according to the applicable industry standards (IEC 61010, IEC 61326 etc.) for electrical safety and electromagnetic compatibility by accredited laboratories. We are able to support any other kind of non-EU product standard.
MDSAP (Medical Device Single Audit Program).
The MDSAP program allows bodies (Auditing Organizations – AO) recognized and accredited by the Regulatory Authorities of the five participating countries (U.S.A., Canada, Brazil, Japan and Australia) to conduct a single audit at the manufacturers of Medical Devices to verify that the latter satisfy the Quality System management requirements (GMP: Good Manufacturing Practice) of the reference countries.
We comply with ISO 13485, a quality management system standard specifically for medical device companies that incorporates aspects of ISO 9001 and specific requirements for the medical device sector. The main objective of ISO 13485, in a highly regulated context worldwide, is to promote global harmonization of the requirements of medical device regulations. It is therefore a basic voluntary standard that applies to the different quality systems and regulations for the production and placing on the market of medical devices, from simple gauze to the most sophisticated diagnostic imaging devices or minimally invasive surgical instruments. ISO 13485 is the internationally recognized standard for quality management systems in the medical device sector; it is intended for use by any organization involved in the design, development, production, installation and technical support of medical devices or related services.
We have achieved certification of conformity to ISO 14001, which identifies a technical standard of the International Organization for Standardization (ISO) on environmental management systems (EMS) that establishes the requirements for an environmental management system of an organization. It is part of the ISO 14000 series of standards developed by the Technical Committee (TC) ISO/TC 207.
We have achieved certification of conformity to the ISO/IEC 27001 standard (Information technology - Security techniques - Information security management systems - Requirements), which is an international standard that contains the requirements for setting up and managing an information security management system (SGSI or ISMS, from the English Information Security Management System). It is part of the ISO 27000 series of standards for information security and management. ISO 27001 is not (only) a computer security standard as, in addition to logical security, it includes physical/environmental security and organizational security.
Visia Lab is a leading Italian company in the In Vitro Diagnostics Device technology sector.
Request documentation and techincal sheets of our products
IFA All-in-One slide processing and reading system.
The automatic system to digitize slides LIVE, even remotely.
Your state of the art IFA slide automatic scanner.
