Guidelines for the selection of consultants advising SMEs on integrated quality, environment, health and safety management systems

This CEN Workshop Agreement (CEN CWA 16275) has been drafted and approved by a Workshop of representatives of interested parties, the constitution of which is indicated in the foreword of this Workshop Agreement.
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AVIS, the Italian Association of Blood Volunteers in Milan, is burdened with the obligation to comply with all the rules and regulations required by Health Accreditation (national and European standards), Good Practices in the Pharmaceutical Sector, Occupational Safety, ISO 9000:2015 (Quality), Privacy, Data Protection and IT Security (GDPR).

It has recognized the digital platform as an ideal tool to manage the legal requirements in a single system, actively involving and supporting all staff in conformity with the rules and regulations during their daily work. The same people, equipment and processes are involved in the different contents for monitoring, so it was essential to avoid redundancies, data processing, and certainty of updating.

The clear and logical structure of the platform, which offers structural content such as generic processes and risk assessment catalogues, allowed AVIS to be immediately operational. After 5 days of training and only 3 weeks (8 hours/day) of customization, the platform is in use and grows day by day following the process of continual improvement.
The knowledge inside AVIS-Milan regarding “how”, “why” and “what are the rules is now available to managers and employees at an individual level, through a workstation (dashboard) customized for each role and workplace, which allows the employees to receive a legally compliant answer to their question with a simple click. Tutto ciò secondo i compiti attribuiti e sulla base del “bisogno di sapere” di ognuno, in modo che tutti i requisiti necessari diventino trasparenti e siano convogliati attraverso l’organizzazione in una fonte di risorse facilmente accessibile.

For AVIS, the social impact is clear: the digital platform supports staff in optimising their time and the quality of their daily work, ensuring safety and high quality services to blood donors thus reducing risks and costs in a measurable and sustainable manner.

Vanghelis Spiridon, technical coordinator, head of medical procurement and member of the quality team at AVIS writes: “…to perform these functions I have always looked for a tool that would help me in my work in a flexible way, adapted to my needs, to those of our organization and the growing need to comply with ISO standards, the new GDPR standards and Health and Safety at Work. With PROMIS® I have reached a point of optimum management of everything that is my responsibility, I have seen that the nurses and doctors are satisfied with the simplicity of the management system, and above all I am pleased that PROMIS® follows and meets all my needs in the service of AVIS.