the QUALITY Management ( iso 9001:2015, en 14885-2014 )

ISO 9000 - Quality management The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

ISO 9001:2015 - QUALITY MANAGEMENT ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.

This standard is based on a number of quality management principles including strong customer focus, motivation and implication of top management, process approach and continual improvement. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn bring many business benefits.

Quality management principles: The seven quality management principles are: 1 - Customer focus : To meet customer requirements 2 - Leadership : Leaders create conditions in which people are engaged in achieving the organization’s quality objectives. 3 - Engagement of people : Engaged people at all levels 4 - Process approach : As a coherent system 5 - Improvement : Is essential for an organization to maintain current levels of performance 6 - Evidence-based decision making : Decisions based on the analysis 7 - Relationship management : For sustained success, an organization manages its relationships with interested parties, such as suppliers. ( These principles are not listed in priority order ) .

THE QUALITY MANAGEMENT IS BASED ON THE PROCESSES WHAT IS THE PROCESS ? THE PROCESS IS A SET OF ACTIVITIES THAT TRANSFORM AN INPUT INTO AN OUTPUT. THE FINAL PRODUCT

WHICH ARE THE BENEFITS? With the new standard in place (ISO 9001:2015), organizations will find it easier to incorporate their quality management system into the core business processes and gain greater business benefit. FOR EXAMPLE: The emphasis on leadership The focus on risk management and opportunity management Emphasis on objectives measurement and change Communication and awareness The focus on customer’s requirements The quality management is completely integrated and aligned with the business strategies of your organization

What is the en 14885 ? It is a European Standard that specifies the laboratory methods to be used for testing the activity of products : chemical disinfectants and antiseptics, in order to support claims that have specific properties for their intended application. These laboratory methods may also be used for active substances and products under development.

Application of European Standards for chemical disinfectants and antiseptics: en 14885 This document has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR. It was published in 2006 but in 2014 it was revised to adapt it to the latest state of science, to correct errors and ambiguities, thereby to make it more understandable.

ENVIRONMENTAL IMPACT ( En 14885) : The test methods in this European Standard are based on the current scientific state of the art. Chemical disinfectants and antiseptics should always be used responsibly taking into consideration the environmental impact of inappropriate product in-use concentrations (too high or too low) and of unnecessary use.

when is the EN 14885 applicable? It is applicable : to products whose activity is claimed against the following microorganisms: vegetative bacteria, bacterial spores, yeasts, fungal spores and viruses. to products used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas.

Labeling : According to the European standard, every firm must indicate important information on the label :   Type and purpose of the product (hands, surfaces, instrumental)   Area and scope (medical, veterinary ..)   Spectrum of activity with the reference European standard (EN-...)  Recommended method of application (concentration of use, method of application)   Dirty conditions (only applies to the veterinary area )

What is the connection between: economy, quality and the product ? The connection is very important for the business! In general when we talk about QUALITY, we refer to concept customer satisfaction. An organization does QUALITY when responds to all customers's needs. This is the target of the business.

In the sanitary sector there’s the same concept. Taking into consideration EN 14885, we can see specific laboratory methods to be used for testing the activity of products : chemical disinfectants and antiseptics. The objective is to respond to all customers's needs, according to European Standard (Ref. EN 14885).

HEALTH ECONOMY: In these case we can talk of “health economy". Is the application of economics principles in the health sector with two main objectives : priority and equity. Priority means maximize the benefits, and every sanitary services they must be shared with Equity for the society.

. In these slides we have talked about ISO 9000, ISO 9001( for the generally firm) and EN 14885 that are the European rules for antiseptic and chemical disinfectants in the health sector. They are very important for the organization because provide the guide and tools for companies that wants to improve , or to start, their business. Thank you for your attention !