Health Certification, Inspection & Services

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1 Health Certification, Inspection & Services ENVIRONMENT & SUSTAINABILITY Marine Energy Business Assurance Transport & Infrastructures IFIs, Banks and Investors INNOVATION

2 company PROFILE RINA SERVICES S.p.A. is the RINA Group company active in classification, certification, inspection and testing services. RINA is a multi-national Group which offers verification, certification, conformity assessment, marine classification, environmental enhancement, product testing, site and vendor supervision, training and engineering consultancy across a wide range of industries and services. RINA operates through a network of companies covering Marine, Energy, Infrastructures & Construction, Transport & Logistics, Food & Agriculture, Environment & Sustainability, Finance & Public Institutions and Business Governance. With a turnover of over 330 million Euros in 2014, over 2,750 employees, and 163 offices in 60 countries worldwide, RINA is recognized as an authoritative member of key international organizations and an important contributor to the development of new legislative standards. the market For some years now, the community has expressed a growing request for improved overall quality of the services offered by the health sector. Patients, families and users in general are particularly sensitive towards aspects such as the appropriateness and overall quality of the services provided, the professionalism and competency of the operators, humanisation of the relationship with patients and their families, containment of and compliance with waiting times, demonstration of a decision-taking approach based on objectivity and transparency. National and local legislation, developed to meet the community s need, draws the attention of every level of the health system to organisational models able to manage and monitor the critical factors of socialhealth services, particular attention being given to constantly improving the services whilst containing and controlling costs. In this context, it becomes strategic, for the health service and its management, to be able to manage, control, demonstrate and ensure the correctness, effectiveness and commitment assumed, at all levels of the structure, in pursuit of management which is attentive to the needs of users, in line with regulatory requirements, characterised by the constant search for opportunities to improve. RINA has responded to this diversified scenario by offering a wide range of certification services, aimed at the different spheres and values through which the health structures interface.

3 Quality management It ensures the health service has the ability to manage and control its processes with coherence in relation to the needs of users and to constantly monitor the efficacy of the services provided. Certification of Quality Management Systems ISO 9001 Safety Management and control of critical aspects Instruments that ensure the health service pursues a policy which considers the aspects of global safety, meaning both protection of operators and patients and guests. Certification of occupational health and safety management systems BS OHSAS standard Certification of information security management systems ISO/IEC Certification of a hospital s internet site Q-WEB Mark Periodical surveillance checks of electrical installations Italian law no. 462/01 Periodical surveillance audits of lifts Italian law no. 162/99 Certification of systems for the prevention of hazards and hygiene control in catering services (HACCP) - UNI standard

4 ETICs Ethical principles which underlie the promise of well-being The community s attention to ethical aspects associated with working relations and work management is constantly increasing. Having organisational-managerial tools able to ensure that a careful policy of respect for and protection of traditional values of fairness, objective assessments, transparency and clarity in decision-making processes is pursued, is a fundamental qualifying element for an organisation projected towards objectives of excellence. Certification of social accountability management systems SA 8000 standard Certification of management system compliance (for the purpose of preventing crimes for which corporate administrative responsibility ensues) Italian legislative decree 231/01 Property assets Enhancement of buildings in relation to the environment Enhancement of property assets is a strategic point in the management of health structures. Certification of environmental management systems ISO standard Validation of the environmental statement EMAS Council Regulation Certification of the Quality of Buildings (objective means to measure the state of preservation and safety of a building and to identify aspects which can be improved, even in connection with management).

5 Accreditation Performance measurement, risk management Supported by a large, diversified and loyal clientele, RINA pursues a policy of global service and assistance to companies and organisations which see, in our body, a partner to attain avant-garde objectives and goals of excellence. In this light and aware of the delicacy, specificity and need for high level qualification which characterise social-health structures, RINA offers: Personalised certification projects for specific needs related to monitoring, assessment, measurement and certification of the services provided and for risk control. The numerous accreditations obtained by RINA bear witness to its professionalism, competency and operational efficiency and act as a guarantee for clients and the community in general. In the Health and Social Work sector RINA has acquired considerable competency and proven professionalism thanks to its investment in the training of specific resources: ACCREDIA and ANAB accreditation for the ISO 9001 scheme in sector 38 - Health and Social Work numerous certificates, both in Italy and abroad, for hospital units, clinics and nursing homes, laboratories, rehabilitation and social assistance services qualification of audit teams. Advantages containment of costs and rationalisation of investments containment of insurance premiums greater guarantee for the user and protection for the management and operators against damage derived from ecological risks.

6 Medical devices ISO Medical Devices - Quality Management Systems - Requirements for regulatory purposes Is a voluntary standard for the certification of quality management systems for those who design, manufacture, trade, install and offer technical assistance in the field of medical devices. ISO 13485, that can be integrated with the ISO 9001 standard, is a useful tool for organizations which work in the European Union according to the EU Directives concerning medical devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices; as well as for organizations operating outside the EU, which intend to demonstrate the requirements of quality and safety of their devices. MEDICINAL PRODUCTS ISO 15378: Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001, with reference to Good Manufacturing Practice (GMP). The ISO 15378:2008 Standard establishes the requirements for implementation of the GMP principles in design, production and control of primary packaging materials for medicinal products (cellulose, polyethylene, glass, other). The Standard includes general requirements for Quality Systems and adds specific requisites linked to Good Manufacturing Practices, to verification and validation of the materials produced and to the performance of a risk analysis related to production of packaging materials for medicines. This Standard allows companies which produce primary packaging for pharmaceuticals to fully meet their clients needs and may also reduce the number of second party audits by these companies.

7 LAUNDRY UNI EN Laundry processed textiles Biocontamination control system The Standard provides a Risk Analysis and Biocontamination Control system (RABC) for the washing processes of textile products intended for critical uses, from the point of view of microbiological quality. The Standard can be applied to industrial laundries which deal with textiles to be used in the health, hospital, pharmaceutical, food and hotel sectors. Among the most critical uses are those in particular in operating theatres, immune defence departments and major burn centres, where reduction of the bacterial load is an essential prerequisite for the effectiveness of the subsequent sterilisation process. ISO certification ensures that the industrial laundry applies an effective system of prevention and control of the risk of product biocontamination, derived from both the previous use of the product and the phases following use. In this way, the laundry guarantees end users and any intermediate clients a microbiologically controlled product, thus promoting maintenance of a chain characterised by prevention principles and aimed at protecting the health of the individual and, in particular, of weak and risk categories.

8 HEALTH CARE SERVICES EN Health care services - Quality management systems Requirements based on EN ISO 9001:2008 Self-standing standard for organizations which need to demonstrate their ability to produce good quality health care. The standard aims to adapt the requirements, as well as the product concept and customer expectations established in EN ISO 9001:2008, to the specific conditions for health care where products are mainly services and customers are mainly patients. This European Standard is applicable to e.g. primary health care, pre-hospital and hospital care, tertiary care, nursing homes, hospices, preventive health care, mental health services, dental services, physiotherapy, occupational health services and pharmacies. SOCIAL SERVICES UNI Services Nursing homes Guidelines for the implementation of a quality system according to the UNI EN ISO 9001 Standard in structures which provide residential assistance services to elderly people, both self-sufficient and non self-sufficient. The purpose is to offer the user, in close collaboration with territorial services and the family, a competent and long-term residential and care service which ensures the best possible quality of life, while respecting the person s individuality, dignity and privacy, taking into account particular physical, psychic, social and relational needs, encouraging where possible functional autonomy, social and community integration and reducing situations of discomfort. Target structures: nursing homes care homes. The Standard defines the requirements for the following residential types: specialised residential home due to the gravity and condition of the elderly people (mono-structure) residential home divided into nuclei for elderly people with differing disabilities and needs (poly-functional structure). UNI Service Children s Home This Standard represents the reference for quality management system certification in homes for children with differing social needs, taking into account various types of adolescents:

9 children with psycho-relational problems, with personality disorders and/or who live their lives in conditions of profound isolation children from families who have serious difficulty in bringing up their own children or who are unable to do so children who have relational problems at school and in youth centres children habitually involved in peer groups at risk (adolescent gangs) children identified by the Juvenile Court. Target structures: communities where educational action is undertaken by a team of professional operators communities which accept children, in situations of extreme hardship and with no preventive intervention project, for short periods until they can be suitably resettled family type communities where educational activities are undertaken by two or more adults who live with the children, also with their own children, taking on parental duties apartment-group type communities where young people around or over the age of 18 are accepted, who no longer come under the services for children, subject to completion of the educational programme to achieve autonomy and definitive integration into society. The educational action does not require the continuous presence of operators within the structure. UNI Services - Residential and day services for disabled persons This Standard represents a point of reference for organisations which provide social-assistance services, in residential and daytime structures, for the disabled. It includes a multi-dimensional assessment of the user by properly qualified personnel, in view of work projects and objectives oriented towards results. It applies to social, educational, assistance, socio-rehabilitative services, both residential and daytime, for people with physical, psychic or sensorial disabilities, stabilised or progressive, which cause learning, relational or work integration difficulties. UNI Early childhood services A tool which guarantees the reliability and safety of the structures intended to take in young children, thus enabling an objective verification to be obtained of the quality of the service and structure. It defines management of the day and of the acclimatisation and integration phases of the child, thus creating the basis for untroubled development of the young guests. Target services: services for early childhood (up to the age of three) services for early childhood with educational services also aimed at the 3-6 age group educational services designed for the 0-6 age group, such as early childhood centres, public and private.

10 COSMETICS ISO Cosmetics - Good Manufacturing Practices The Standard describes Good Manufacturing Practices, in line with the state of the art of the sector. In line with European legislation on the matter, it establishes requirements: of an organisational and managerial nature, relevant to the personnel, with particular reference to the hygiene and health of operators and visitors concerning premises related to equipment and packaging relevant to production and packaging processes and laboratory controls. It is a support tool to improve a cosmetic company s management. It offers a greater guarantee to the client and consumers concerning the requirements of quality, dermatological safety and performance efficacy of the product. It encourages systematic implementation and therefore, capitalisation of good practices of the sector. It ensures compliance with the applicable mandatory legislation. UNI ISO Cosmetics - Packaging and labelling This international Standard specifies the packaging and labelling requirements for all cosmetic products defined according to national rules or practices, intended for sale or free distribution.

11 Heath Inspection ITA - Istituto Tecnologie Avanzate To complete the services offered by the Health sector of the RINA, Inspection and Services are carried out by the ITA laboratory - Istituto Tecnologie Avanzate. The laboratory operates nationally, providing high added value services to clients in the hospital and hospitality sectors. The services range from auditing activities carried out in hospitals which have facilities for providing meals and cooking and in hotels and production plants to verify compliance with supply contracts or other reference standards. A further area of specific activity is risk assessment of air-conditioning systems as regards microbiological aspects as, for example, the Legionella pathogen and air quality analysis systems in highly critical environments.

12 Health & Food ph fax emma.tomaselli@rina.org Via Corsica, Genova - Italy ph fax info@rina.org RINA Corporate Image