| Check list | Objective Evidence |
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Has the organization:
determined the external and internal factors relevant to its strategic goals and directions and that influence its ability to achieve the expected results for its quality management system? |
Evidence recorded on:4/11/2025 Evidence verified on :        by: Italia
Ministry of Health
Conclusione – 04.1.1
L’organizzazione ha identificato fattori esterni e interni rilevanti per lo scopo del SGQ (promozione salute & MCNT), utilizzando dati ufficiali e controlli normativi adeguati. La determinazione è corretta ma non continua a causa dell’irregolare periodicità della RSSP.
Questi input forniscono dati aggiornati e validati per identificare fattori esterni (epidemiologici, sociali, comportamentali) e interni (capacità del sistema prevenzione).
1. Relazione sullo Stato Sanitario del Paese 2017–2021
(sezioni su determinanti salute, fattori di rischio, MCNT, prevenzione)
https://www.salute.gov.it/new/it/pubblicazione/relazione-sullo-stato-sanitario-del-paese-2017-2021
2. Sorveglianze ISS – Dati sui fattori di rischio e determinanti
PASSI / PASSI d’Argento ? https://sorveglianzepassi.iss.it
HBSC adolescenti ? https://www.epicentro.iss.it/hbsc/
OKKIO alla Salute ? https://www.epicentro.iss.it/okkioallasalute/
3. Indicatori epidemiologici e sociali ISTAT
Salute, stili di vita, mortalità evitabile ?
https://www.istat.it/statistiche-per-temi/societa-e-istituzioni/salute-e-sanita
Database Health for All Italia ?
https://www.istat.it/sistema-informativo-6/health-for-all-italia/
4. Documenti di pianificazione sanitaria nazionale
PNP 2020–25 ? https://www.epicentro.iss.it/piano_prevenzione/pnp-2020-25
PNC ? https://www.salute.gov.it/imgs/C_17_pubblicazioni_2584_allegato.pdf
O – OUTPUT
Risultato della determinazione dei fattori:
Fattori esterni individuati (da RSSP e sorveglianze)
determinanti sociali della salute (istruzione, condizioni socioeconomiche, ambiente);
fattori di rischio comportamentali (fumo, alcol, alimentazione, attività fisica);
andamento epidemiologico delle MCNT (diabete, cardiovascolari, BPCO, tumori prevenibili);
coesione sociale, benessere psicologico, condizioni territoriali.
Fattori interni individuati
capacità del sistema prevenzione;
disponibilità di dati istituzionali consolidati;
ruolo della DG Prevenzione, ISS e sorveglianze;
organizzazione ministeriale per promozione salute.
Criticità dell’output
La Relazione sullo Stato Sanitario del Paese, pur essendo la principale evidenza di analisi del contesto, non viene pubblicata con periodicità regolare, limitando la continuità del processo di determinazione dei fattori.
Output: determinazione effettuata, ma con limitazione dovuta alla discontinuità temporale
C – CONTROLLI
Riferimenti normativi e programmatori che guidano la determinazione dei fattori rilevanti:
Legge 833/1978 – Istituzione del SSN
D.Lgs. 502/1992 art. 1, comma 12 – Obbligo Relazione Stato Sanitario
Piano Nazionale della Prevenzione (PNP 2020–2025)
Piano Nazionale della Cronicità (PNC)
Sorveglianze nazionali ISS (PASSI, PASSI d’Argento, HBSC, OKkio)
PASSI / PASSI d’Argento ? https://sorveglianzepassi.iss.it
OKKIO alla Salute ? https://www.epicentro.iss.it/okkioallasalute/
Questi controlli stabiliscono il quadro obbligatorio e metodologico per identificare i fattori esterni ed interni.
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The organization: does it monitor and review information regarding these external and internal factors?
Note 1 Factors may include positive and negative factors, or conditions to be considered.
Note 2 Understanding the external context can be done |
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The organization: has determined the relevant stakeholders for the quality management system? |
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The organization:
has determined the requirements of such stakeholders that are relevant to the quality management system? |
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The organization:
does it monitor and review information regarding these stakeholders and their relevant requirements? |
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Has the organization determined the boundaries and applicability of the quality management system to determine its scope? |
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In determining the scope, has the organisation considered:a) the external and internal factors referred to in point 4.1?
b) the requirements of the relevant stakeholders referred to in point 4.2?
c) the products and services of the organisation? |
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Is the scope of the organization's quality management system available and maintained as documented information? |
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Does the scope of the system state the types of products and services covered? |
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Does the scope of the system provide adequate justification for each requirement of this International Standard that the organization determines is not applicable? (The justification may be considered adequate only if the non-applicable requirements do not affect the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.) |
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Has the organization determined the processes necessary for the quality management system and their application throughout the organization by:
a) determining the necessary inputs and expected outputs from these processes?
b) determining the sequence and interaction of these processes?
c) determining and applying the criteria and methods (including monitoring, measurement and related performance indicators) necessary to ensure the effective operation and control of these processes?
d) determining the resources necessary for these processes and ensuring their availability?
e) assigning responsibilities and authorities for these processes?
g) evaluating these processes and implementing any changes necessary to ensure that these processes achieve the intended results?
h) improving the processes and the quality management system? |
Evidence recorded on:4/11/2025 Evidence verified on :        by: Italia
Ministry of Health
ITALY
Ministry of health
rif. Allegato al Piano Integrato MSAL 2025-2027 vedi in particolare la Direzione generale dei corretti stili di vita e dei rapporti con
l’ecosistema
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Does the organization:a) maintain documented information to support the operation of its processes?</BR>b) maintains documented information so that it can have confidence that processes are conducted as planned? |
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a) When non-conformities occur, including those that arise from complaints, the organization: a) reacts to non-compliance and, as applicable: 1) Does it take action to control and correct it? 2) Does it face the consequences? b) Assess the need for action to eliminate the cause(s) of non-compliance, so that it does not recur or occur elsewhere: 1) reviewing and analyzing non-conformity? 2) determining the causes of non-compliance? 3) determining whether similar non-conformances exist or could occur? c) does it implement any necessary action? (d) Review the effectiveness of any corrective action taken? e) Update, if necessary, the risks and opportunities determined during the planning? f) make changes to the quality management system if necessary? Are the corrective actions adequate to the effects of the non-conformities found? |
Evidence recorded on:4/11/2025 Evidence verified on :        by: Italia
Ministry of Health
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The organization:
b) ensures that these persons are competent on the basis of appropriate education, training, training, or experience? |
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Does top management ensure that responsibilities and authorities for relevant roles are assigned, communicated and understood within the organisation? |
Evidence recorded on:4/11/2025 Evidence verified on :        by: Italia
Ministry of Health
Seguendo la struttura dell'organigramma del ministero della salute si evidenzia che Responsabilità relative alla ricerca in oggetto sono state attribuite al Dipartimento della salute umana, della salute animale e dell'ecosistema(One Health) e dei rapporti internazionali
Il Dipartimento della salute umana, della salute animale e dell'ecosistema(One Health) e dei rapporti internazionali si avvale della Direzione generale dei corretti stili di vita e dei rapporti con l'ecosistema che in merito all’oggetto della presente ricerca svolge le seguenti funzioni:
? individuazione, definizione, valutazione, informazione e promozione di corretti stili di vita, con particolare riferimento all'attività fisica, al fumo, all'alcol, al doping, al sovrappeso e all'obesità, all'allattamento, alla nutrizione e all'invecchiamento attivo, tenuto conto della interazione con l'ecosistema, anche raccordandosi con la Direzione generale della comunicazione
? promozione della salute, con particolare riguardo alle fasce di popolazione vulnerabili (anziani, settore materno infantile, età evolutiva, migranti, persone affette da patologie croniche e di rilievo sociale, disabili, persone non autosufficienti, persone con problemi di salute mentale) • monitoraggio e valutazione del fenomeno delle dipendenze
? tutela della salute umana nei rapporti con l'ecosistema e, in particolare tutela dalle esposizioni ad agenti chimici, fisici e biologici nell'ambiente naturale,
Nel corso dell’attuale processo di riorganizzazione si avvale per l’espletamento delle funzioni sopraelencate dele Ex Direzioni generali e dei relativi Uffici dirigenziali di livello non generale ed in particolare dall’ufifcio 8 del Dipartimento di Prevenzione, della ricerca e delle emergenze sanitarie
Control
DPCM-196-23 Regolamento di organizzazione del Ministero della salute.
(issued on:10/30/2023)
Disciplina l'organizzazione del Ministero della salute.
Dalla sua entrata in vigore In Italia è in corso una riorganizzazione del Ministero della Salute che mira ad avvicinare gli uffici con attività simili dei diversi dipartimenti.
Il cambiamento in atto è riportato nell'ultimo PIAO del Ministero della Salute
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General
Top management must demonstrate leadership and commitment to the quality management system:
a) taking responsibility for the effectiveness of the quality management system; |
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Customer focus
Top management shall demonstrate leadership and commitment to customer focus by ensuring that:
a) customer requirements and applicable statutory and regulatory requirements are determined, understood and consistently met;
b) risks and opportunities that may affect the conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
c) focus on enhancing customer satisfaction is maintained. |
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Does top management assign responsibility and authority to: a) ensure that the quality management system conforms to the requirements of this standard? b) ensure that the processes are producing the intended outputs? c) report, in particular to top management, on the performance of the quality management system and opportunities for improvement? (see 10.1 Improvement) d) ensure that customer focus is promoted throughout the organization? e) ensure that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented? |
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In planning the quality management system, has the organization considered the factors referred to in 4.1 (internal and external factors constituting the context) and the requirements referred to in 4.2 (requirements of interested parties) and determined the risks and opportunities that need to be addressed to: a) provide assurance that the quality management system can achieve the intended results? b) enhance desired effects? c) prevent or reduce undesired effects d) achieve improvement? |
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Does the organization plan:
a) actions to address these risks and opportunities?
b) ways to
1- integrate and implement the actions into its quality management system processes? (see 4.4)
2- evaluate the effectiveness of these actions? |
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Are the actions taken to address risks and opportunities proportionate to the potential impact on the conformity of products and services?
Note 1 Options for addressing risks may include: avoiding the risk, taking the risk to pursue an opportunity, removing the source of risk, changing the likelihood or consequences, sharing the risk, or accepting the risk based on an informed decision.
Note 2 Opportunities may include adopting new practices, launching new products, opening new markets, targeting new customers, forming partnerships, using new technologies, and other desirable and practicable options to address the needs of the organization or its customers. |
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Are the actions taken to address risks and opportunities proportionate to the potential impact on the conformity of products and services?
Note 1 Options for addressing risks may include: avoiding the risk, taking the risk to pursue an opportunity, removing the source of risk, changing the likelihood or consequences, sharing the risk, or accepting the risk based on an informed decision.
Note 2 Opportunities may include adopting new practices, launching new products, opening new markets, targeting new customers, forming partnerships, using new technologies, and other desirable and practicable options to address the needs of the organization or its customers. |
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Does the organisation set quality objectives for the relevant functions, levels and processes necessary for the quality management system? |
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Are the objectives:
a) consistent with the quality policy?
b) measurable?
c) take into account applicable requirements?
d) relevant to the conformity of products and services and to increasing customer satisfaction?
e) monitored?
f) communicated?
g) updated as appropriate? |
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Does the organisation maintain documented information on quality objectives? |
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In planning how to achieve its quality objectives, the organization determines:
a) what will be done?
b) what resources will be required?
c) who will be responsible?
d) when will it be completed?
e) how will the results be evaluated? |
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When the organization determines the need for changes to the quality management system, are they carried out in a planned manner? |
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Does the organization consider:
a) the purposes of the changes and their potential consequences?
b) the integrity of the quality management system?
c) the availability of resources?
d) the allocation or reallocation of responsibilities and authorities? |
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General Does the organization determine and provide the necessary resources for the establishment, implementation, maintenance and continuous improvement of the quality management system? |
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Does the organization consider:
a) the capacities of existing resources within it and the constraints on them?
b) What do you need to get from external suppliers? |
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People
Does the organization determine and make available the necessary people for the effective implementation of its quality management system and for the operation and control of its processes? |
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Infrastructure
Does the organization determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services? Note Infrastructure may include;
a) buildings and related facilities; |
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Environment for the operation of processes
Does the organization determine, make available and maintain the environment necessary for the operation of its processes and to achieve compliance of products and services?
Note A suitable environment can consist of a combination of human and physical factors, such as those of a social nature:
a) social;
b) psychological;
c) physics. |
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1 Monitoring and measurement resources 1 When monitoring or measurement is used to verify the compliance of products and services with requirements, does the organization determine and make available the necessary resources to ensure valid and reliable results 2 The organization ensures that the resources made available disposal: a) are they suitable for the specific type of monitoring and measurement activity to be undertaken? b) are maintained in order to ensure their continuous fitness for purpose? 3 Does the organization maintain appropriate documented information as evidence of fitness for purpose of resources for monitoring and measurement? |
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1 a) Traceability of measurementsi When the traceability of measurements is a requirement or is considered by the organization to be an essential component in providing confidence in the validity of the results of measurement equipment, the measuring equipment is: b) identified in such a way that their status is determined? c) Are they protected against adjustments, damage or deterioration that could invalidate their calibration status and the consequent measurement results? |
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2 When a measuring device is found to be unsuitable for its intended use, the organization determines whether the validity of previous measurement results has been adversely affected and takes appropriate action. for how much necessary? |
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Organizational knowledge Does the organization determine, maintain and make available the knowledge necessary for the operation of its processes and to achieve compliance of products and services? |
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Nota 1 Nota 1
La conoscenza organizzativa è la conoscenza specifica dell’organizzazione, maturata generalmente attraverso l’esperienza. Queste informazioni sono utilizzate e condivise al fine di conseguire gli obiettivi dell’organizzazione. |
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Nota 2 a) Nota 2
La conoscenza organizzativa può essere basata su:</BR> a) risorse interne (per esempio proprietà intellettuale; conoscenze maturate con l’esperienza; lezioni apprese da insuccessi o da progetti che hanno avuto successo; acquisizione e condivisione di conoscenze ed esperienze non documentate; risultati dei miglioramenti ottenuti nei processi, prodotti e servizi); |
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Nota 2 b) Nota 2
La conoscenza organizzativa può essere basata su:</BR> b) risorse esterne (per esempio norme; fonti accademiche; conferenze; raccolta di conoscenze da clienti o fornitori esterni). |
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The organization:
(a) determine the skills required for persons who perform work activities under its control and which influence the performance and effectiveness of the quality management system? |
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7.3 Awareness
The organization ensures that persons who carry out a work activity under its control are aware:
a) of the quality policy?
(b) the relevant quality objectives?
(c) its contribution to the effectiveness of the quality management system, including the benefits deriving from improved performance
(d) the implications of not complying with the requirements of the quality management system?</BR> |
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The organization determines internal and external communications relevant to the quality management system, including:s a) What does it want to communicate?s b) When to communicate?s c) Who to communicate with?s d) how to communicate? e) Who communicates? |
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Generality The organisation's quality management system shall comprise: a) the documented information required by this International Standard? b) the documented information that the organization determines is necessary for the effectiveness of the quality management system? Note The extent of documented quality management system information may vary from one organization to another based on: - the size of the organization and its type of activities, processes, products and services; - the complexity of the processes and their interactions; - the competence of people |
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Creating and updating When creating and updating documented information, the organization shall ensure that appropriate: a) identification and description (e.g. title, date, author or reference number)? b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic)? (c) review and approval of suitability and adequacy? |
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The documented information required by the quality management system and this International Standard shall be monitored to ensure that: a) are they available and suitable for use, where and when needed? b) are adequately protected (e.g. from loss of confidentiality, misuse, or loss of integrity) |
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2 Is documented information of external origin, determined as necessary by the organization for the planning and operation of the quality management system, identified, as appropriate, and kept under control? Note Access may result in a decision about view-only permissions to document information, or permissions and authorities to view and edit it |
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The organization plans, implements and monitors the processes (see clause 4.4) necessary to meet the requirements for the provision of products and services and to implement the actions determined in clause 6: a) determining the requirements for the goods and services? b) establishing the criteria for processes and acceptance of products and services? (c) determining the resources needed to achieve compliance with the requirements for products and services? d) implementing process control in accordance with the criteria? (e) determining, maintaining and maintaining documented information to the extent necessary to have confidence that processes have been carried out as planned and to demonstrate compliance of products, and services to the relevant requirements? |
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Is the output of this planning adequate for the operational activities of the organization? |
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Does the organization keep a close eye on planned changes and review the consequences of unintended changes, taking action to mitigate any negative effects, as necessary? |
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Does the organization ensure that outsourced processes are kept under control? (see point 8.4) |
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uisiti specifici da correlare) 8.2 Requirements for products and services |
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Customer communication Customer communication includes: a) the provision of information relating to products and services? b) the management of requests, contracts or orders, including changes? c) Obtaining feedback from the customer about the products and services, including customer complaints? d) the management or control of the customer's property? (e) the definition of specific requirements for emergency actions, where relevant? |
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Determination of requirements for products and services In determining the requirements of the products and services to be offered to customers, the organization ensures that: a) are the requirements of the products and services defined, including any applicable mandatory requirements and those deemed necessary by the organization? b) is the organization able to meet what it claims in relation to the products and services offered? |
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Review of requirements for products and services Does the organization ensure that it has the ability to meet the requirements of the products and services to be offered to customers? |
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1 b) Prima di impegnarsi a fornire prodotti e servizi al cliente, l’organizzazione conduce un riesame che comprenda: a) i requisiti specificati dal cliente, compresi i requisiti per le attività di consegna e post-consegna? |
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3 If the customer does not provide a documented statement of their requirements, are the customer's requirements confirmed by the organization before they are accepted? Note In some situations, such as in the case of internet sales, a formal review is impractical for every order. Instead, the review may cover relevant product information, such as catalogues. |
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If the customer does not provide a documented statement of their requirements, are the customer's requirements confirmed by the organization before they are accepted? Note In some situations, such as in the case of internet sales, a formal review is impractical for every order. Instead, the review may cover relevant product information, such as catalogues. |
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Changes to requirements for products and services When product and service requirements change, your organization ensures that the relevant information are up to date and that relevant persons are made aware of the changed requirements? |
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Has the organization established, implements and maintains an appropriate design and development process to ensure the subsequent provision of products and provision of services? |
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Design planning and development In determining the phases and controls for design and development, the organization considers: a) the nature, duration and complexity of the design and development activities? (b) the necessary steps in the process, including applicable design and development reviews? c) the necessary verification and validation activities of the design and development? d) the responsibilities and authorities involved in the design and development process? e) the needs of internal and external resources for the design and development of products and services? f) the need to keep under control the interfaces between the people involved in the design and development process? g) the need to involve customers and users in the design and development process? h) the requirements for the subsequent supply of products and provision of services? (i) the level of control of the design process, and development expected by customers and other relevant stakeholders? (j) the documented information necessary to demonstrate that the design and development requirements have been met? |
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Design and development input Does the organization determine the essential requirements for the specific types of products and services to be designed and developed? |
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Does the organization continuously improve the suitability, adequacy and effectiveness of the quality management system? |
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CONTESTO DELL’ORGANIZZAZIONE |
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Leadership and commitment |
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Planning |
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SUPPORTO |
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OPERATIONAL ACTIVITIES |
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PERFORMANCE EVALUATION |
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IMPROVEMENT |