Health care services - Quality management systems - Requirements based on EN ISO 9001:2015

The standard specifies requirements for a quality management system in a healthcare organization

Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme - Anforderungen nach EN ISO 9001:2015

Services de santé - Systèmes de management de la qualité - Application de l'EN ISO 9001:2015 aux soins de santé

La présente Norme internationale spécifie les exigences relatives au système de management de la qualité lorsqu’une organisation de soins de santé :
a)   doit démontrer son aptitude à fournir en permanence des produits ou des prestations de soins de santé conformes aux exigences du client et aux exigences légales et réglementaires applicables ; et
b)   vise à accroître la satisfaction de ses clients par l’application efficace du système, y compris les processus pour l’amélioration du système et l’assurance de la conformité aux exigences des clients, aux exigences légales et réglementaires applicables et aux exigences liées aux aspects qualitatifs : juste soins, disponibilité, continuité des soins, efficacité, efficience, équité, fondement des soins sur des preuves/connaissances, centrage des soins sur le patient, y compris son intégrité physique, psychologique et sociale, implication du patient, sécurité du patient et rapidité/accessibilité.
Toutes les exigences de la présente Norme internationale sont génériques et prévues pour s’appliquer à toute organisation de soins de santé, quels que soient son type ou sa taille, ou les produits et services qu’elle fournit.
NOTE 1   Dans la présente Norme, les termes « produit » et « service »/« prestation » s’appliquent uniquement aux produits et services/prestations destinés à, ou exigés par, un client.
NOTE 2   L’expression « legal requirement » recouvre en anglais le concept d’exigence légale et réglementaire.
Les exigences liées aux éléments de sortie matériels tels que les tissus, produits sanguins, produits pharmaceutiques, produits de culture cellulaire et dispositifs médicaux, n’ont pas été intégrées au domaine d’application de la présente Norme car elles sont traitées par ailleurs.
La présente Norme s’attache aux exigences relatives à la gestion des processus cliniques. Les organismes dont le système de management de la qualité inclut également des processus de recherche ou d’éducation peuvent utiliser les exigences de la présente Norme le cas échéant.
La présente Norme vise à spécifier et à compléter les exigences de l’EN ISO 9001:2015 pour les adapter aux conditions particulières des soins de santé, où les produits sont principalement des services et les clients principalement des patients.
1.1   Application
La présente Norme
a)   formule des exigences relatives à des approches systématiques concernant l’aptitude d’un organisme à produire des prestations de soins de santé de qualité ;
b)   peut être employée à tous les niveaux de l’organisation de soins de santé pour mettre en œuvre et tenir à jour un système de management de la qualité ou être utilisée par des parties internes et externes, dont les organismes de certification, pour évaluer l’aptitude de l’organisme à répondre aux besoins et aux attentes des patients et autres clients ;
c)   est applicable aux organisations de soins de santé, quels que soient leur structure, leur organisation, leur propriétaire, leur taille ou les types de prestations de soins de santé qu’elles proposent ;
d)   s’attache aux exigences relatives aux processus cliniques. Les organismes dont le système de management de la qualité inclut également des processus de recherche ou d’éducation peuvent utiliser les exigences de la présente Norme le cas échéant.

Zdravstvene storitve - Sistemi vodenja kakovosti - Zahteve na osnovi EN ISO 9001:2015

Ta evropski standard določa zahteve za sistem vodenja kakovosti v zdravstveni organizaciji.

General Information

Status
Published
Public Enquiry End Date
05-Apr-2016
Publication Date
12-Jan-2017
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
04-Jan-2017
Due Date
11-Mar-2017
Completion Date
13-Jan-2017

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zdravstvene storitve - Sistemi vodenja kakovosti - Zahteve na osnovi EN ISO 9001:2015Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme - Anforderungen nach EN ISO 9001:2015Services de santé - Systèmes de management de la qualité - Application de l'EN ISO 9001:2015 aux soins de santéHealth care services - Quality management systems - Requirements based on EN ISO 9001:201511.020.01Vodenje kakovosti in ravnanje z okoljem v zdravstvuQuality and environmental management in health care03.100.70Sistemi vodenjaManagement systemsICS:Ta slovenski standard je istoveten z:EN 15224:2016SIST EN 15224:2017en,fr,de01-februar-2017SIST EN 15224:2017SLOVENSKI

STANDARDSIST EN 15224:20121DGRPHãþD
SIST EN 15224:2017
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15224
December
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s sä r t rä r s Supersedes EN
s w t t vã t r s tEnglish Version
Quality management systems æ EN ISO

{ r r sã t r s w for healthcare Services de santé æ Systèmes de management de la qualité æ Application de l 5EN ISO

{ r r sã t r s w aux soins de santé
Qualitätsmanagementsysteme æ EN ISO

{ r r sã t r s w für die Gesundheitsversorgung This European Standard was approved by CEN on

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egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä

translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä

CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey andUnited Kingdomä

EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels

t r s x CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN

s w t t vã t r s x ESIST EN 15224:2017
EN 15224:2016 (E) 2 Contents

European foreword ....................................................................................................................................................... 4 Introduction .................................................................................................................................................................... 5 1 Scope ...................................................................................................................................................................... 15 2 Normative references ...................................................................................................................................... 16 3 Terms and definitions ..................................................................................................................................... 16 4 Context of the organization ........................................................................................................................... 27 4.1 Understanding the organization and its context ................................................................................................. 27 4.2 Understanding the needs and expectations of interested parties ................................................................ 28 4.3 Determining the scope of the quality management system ............................................................................ 28 4.4 Quality management system and its processes ..................................................................................................... 28 5 Leadership ........................................................................................................................................................... 29 5.1 Leadership and commitment......................................................................................................................................... 29 5.2 Policy......................................................................................................................................................................................... 31 5.3 Organizational roles, responsibilities and authorities ...................................................................................... 31 6 Planning ............................................................................................................................................................... 32 6.1 Actions to address risks and opportunities ............................................................................................................. 32 6.2 Quality objectives and planning to achieve them ................................................................................................ 33 6.3 Planning of changes ........................................................................................................................................................... 34 7 Support ................................................................................................................................................................. 34 7.1 Resources ................................................................................................................................................................................ 34 7.2 Competence ........................................................................................................................................................................... 36 7.3 Awareness............................................................................................................................................................................... 37 7.4 Communication .................................................................................................................................................................... 37 7.5 Documented information ................................................................................................................................................ 38 8 Operation ............................................................................................................................................................. 40 8.1 Operational planning and control .............................................................................................................................. 40 8.2 Requirements for products and services .................................................................................................................. 41 8.3 Design and development of products and services .............................................................................................. 43 8.4 Control of externally provided healthcare processes, products and services ......................................... 45 8.5 Production and service provision ................................................................................................................................ 47 8.6 Release of products and services ................................................................................................................................. 49 8.7 Control of nonconforming outputs ............................................................................................................................. 50 9 Performance evaluation ................................................................................................................................. 51 9.1 Monitoring, measurement, analysis and evaluation .......................................................................................... 51 9.2 Internal audit ........................................................................................................................................................................ 52 9.3 Management review .......................................................................................................................................................... 52 10 Improvement ...................................................................................................................................................... 54 10.1 General ..................................................................................................................................................................................... 54 10.2 Nonconformity and corrective action ....................................................................................................................... 54 10.3 Continual improvement ................................................................................................................................................... 55 Annex A (informative)

Clarification of new structure, terminology and concepts ........................... 56 A.1 Structure and terminology ....................................................................................................................... 56 SIST EN 15224:2017

EN 15224:2016 (E) 3 A.2 Products and services ................................................................................................................................. 57 A.3 Understanding the needs and expectations of interested parties .............................................. 57 A.4 Risk-based thinking and systematic clinical risk management .................................................... 58 A.5 Applicability ................................................................................................................................................... 58 A.6 Documented information .......................................................................................................................... 59 A.7 Organizational knowledge ........................................................................................................................ 59 A.8 Control of externally provided healthcare products and services ............................................. 60 Annex B (informative)

Other International Standards on quality management and quality management systems developed by ISO/TC 176 ............................................................................................ 61 Annex C (informative)

Correlation matrix EN 15224:2012 to EN ISO 9001:2015 to EN 15224:2016 ................................................................................................................................................................... 65 Annex D (informative)

Quality requirements and quality characteristics in healthcare .................. 71 Annex E (informative)

Guidance for process approach in healthcare ..................................................... 74 E.1 Background ..................................................................................................................................................... 74 E.2 Processes and workflow in general ......................................................................................................... 74 E.3 Clinical Processes .......................................................................................................................................... 75 E.4 Analysis and management of clinical processes ................................................................................. 79 Bibliography ................................................................................................................................................................. 82

SIST EN 15224:2017

EN 15224:2016 (E) 4 European foreword This document (EN 15224:2016) has been prepared by Technical Committee CEN/TC 362, Health care services – Quality management systems, the secretariat of which is held by SIS. This document supersedes EN 15224:2012. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2017, and conflicting national standards shall be withdrawn at the latest by June 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 15224:2017

EN 15224:2016 (E) 5 Introduction 0.1 General The adoption of a quality management system is a strategic decision for a healthcare organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to a healthcare organization of implementing a quality management system based on this standard are: a) the ability to consistently provide healthcare products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements. This standard can be used by internal and external parties. It is not the intent of this standard to imply the need for: — uniformity in the structure of different quality management systems; — alignment of documentation to the clause structure of this standard; — the use of the specific terminology of this standard within the organization. This standard includes requirements for quality management but does not specify requirements for specific healthcare services. The quality management system requirements specified in this standard are supposed to be complemented by requirements for levels of healthcare services . This standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. The process approach enables an organization to plan its clinical and other processes and their interactions. The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed and opportunities for improvement are identified and acted on. Risk-based thinking enables a healthcare organization to determine the factors that could cause its clinical and other processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see A.4). Consistently meeting requirements and addressing future needs and expectations poses a challenge for healthcare organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization. In this standard, the following verbal forms are used: — “shall” indicates a requirement; — “should” indicates a recommendation; — “may” indicates a permission; — “can” indicates a possibility or a capability. SIST EN 15224:2017

EN 15224:2016 (E) 6 Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement. 0.1.1 Quality management in healthcare This is a sector specific quality management system standard for healthcare. This standard incorporates EN ISO 9001:2015 and adds interpretations, explanations, examples and additional requirements. This standard replaces EN 15224:2012. Additional text specific to healthcare is shown in blue italics in Clause 0 to 10 and in Annex A and B. Information marked as “NOTE” in Clause 4 to 10 is for guidance on understanding or clarifying the associated requirement. In Clause 3 such additional information is written “note to entry” according to CEN rules. However, if the aspect refers to a special cited external document the format follows from that document (e.g. as NOTE from ISO 13940). This is a standalone standard and can be used for conformity assessment for certification purposes of healthcare organizations. The requirements in this standard comprehensively incorporate those from EN ISO 9001:2015 with additional requirements, specifications and interpretations for healthcare. Requirements have been added when considered relevant and existing requirements are clarified according to the specific healthcare context. This standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes. ISO 9001:2008 has been reviewed and important changes were included in EN ISO 9001:2015. Some examples of major changes are: - “Risk-based thinking” is an approach that flows through the new standard in Clauses 4,5,6 8,9 and 10 - Two new clauses (4.1, 4.2) relating to the context of the organization are included. These require that the organization determines the issues and requirements that can have impact on the planning of the quality management system These changes are important to be aware of when the reviewed standard is applied. All changes have been considered in this review of EN 15224. 0.1.2 The concept of health The World Health Organization (WHO) declaration of health is “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” The International Classification of Functioning, Disability and Health (ICF), by WHO, identifies five health components; body function, body structure, activity, participation and environmental factors. These descriptions from WHO are used as the basis and background for the concept of “health” in this standard. 0.1.3 Healthcare in relation to social care Healthcare is in this standard defined as “care activities, services management or supplies related to the health of an individual”. The concept of health relates to both healthcare and social care. This standard is focused on requirements for healthcare. What is included in healthcare can differ from country to country and this has to be considered in national applications. In this standard healthcare includes e.g. primary healthcare, pre-hospital and hospital care, tertiary care, nursing homes, hospices, preventive healthcare, mental health services, dental services, physiotherapy, occupational health services, rehabilitation and pharmacies. 0.1.4 Quality, quality requirements and quality characteristics in healthcare Quality in general is defined in EN ISO 9000:2015 as “degree to which a set of inherent characteristics of an object fulfils requirements”. Requirement is defined in EN ISO 9000:2015 as: “needs or expectations that are stated, generally implied or obligatory”. Quality requirements concerning healthcare products and services shall be determined for the quality management system of a healthcare organization according to 8.2.2 and include: SIST EN 15224:2017

EN 15224:2016 (E) 7 1) any applicable statutory and regulatory requirements. According to national legislation quality requirements may differ; 2) those considered necessary by the organization which may include requirements a) not stated by the patient but related to the quality level of services offered by the organization; b) based on scientific evidence and clinical knowledge; c) from other interested parties, e.g. purchasers of services, insurance companies and funding organizations. This means that the healthcare organization has to consider a broad variety of quality aspects from several perspectives when determining the quality requirements included in their quality management system. The context of the organization described in 4.1 will set the scope also for the quality requirements. The main aim for any healthcare organization is to contribute to the health state of the persons that are potential or current patients with different kinds of health needs based on health conditions. Quality requirements should reflect these health needs identified in the patient population. When defining health needs the components of health from the International Classification for Functioning, Disability and Health (ICF) from WHO should be used for categorization and specification of quality requirements. Health needs based on ICF can be specified by the patient and/or by the professional actors interacting with the patients in clinical processes. Scientific evidence and/or clinical knowledge is another perspective to be considered when determining quality requirements. This standard identifies eleven basic quality aspects that by clinical experience are known to be relevant in healthcare organizations. To assess fulfilment of quality requirements the organization need to specify quality characteristics related to these requirements. These are also included in the list of complex aspects that shall be considered (assessed if relevant) when a healthcare organization determines the quality requirements for healthcare services as outcomes of clinical processes. The identified eleven basic quality aspects from this perspective are: — appropriate, correct care; — availability; — continuity of care; — effectiveness; — efficiency; — equity; — evidence/knowledge based care; — patient centred care including physical, psychological and social integrity (ICF); — patient involvement; — patient safety; — timeliness/accessibility; These basic aspects are not always comprehensive or applicable in total. Other aspects often need to be considered for determining all quality requirements considered relevant by the healthcare organization. SIST EN 15224:2017

EN 15224:2016 (E) 8 However, these eleven aspects are ensuring that most aspects that are commonly known as relevant will be considered. If the healthcare organization considers any of the eleven basic aspects not to be relevant or applicable it can exclude that aspect. Reasons for exclusion shall, according to 8.2.2 be retained as documented information. Other quality requirements can be based on the perspectives from other interested parties. An example of such is insurance companies stating certain levels of accessibility for persons with specific health problems. Quality characteristic is defined in ISO 9000:2015 as: “inherent characteristic of an object related to a requirement”. This means that any quality requirement determined by the organization will also relate to one or more quality characteristics of the processes, services and/or the healthcare system as such. In 9.1 is stated that: “The organization shall monitor and measure the outcomes of the clinical processes to verify that requirements related to quality aspects have been met.” In summary, identified quality aspects of healthcare services, processes and systems are needed to specify and determine quality characteristics possible to validate. In healthcare with focus on the clinical aspects and the clinical processes, the quality characteristics related to the health needs of patients and the eleven basic quality aspects identified in this standard are of special importance. With a process approach recommended in EN ISO 9001:2015 this can be achieved by systematic clinical process management. Further guidance for such a clinical process approach is given in Annex E. 0.1.5 The concept of “clinical” The term “clinical” can have different meanings in different countries. In this standard “clinical” refers to all types of interactions between patients and healthcare personnel. “Clinical” always include the patient perspective and the interaction with all types of healthcare personnel, regardless professional entitlement (like doctor, nurse, physiotherapist etc.). 0.1.6 Clinical risk In EN ISO 9000:2015 risk is defined as ”effect of uncertainty”. EN 15224:2016 applies the definition from ISO 31000:2009 where risk is defined as ”effect of uncertainty on objectives”. The definition from ISO 31000:2009 is preferred since EN 15224 explicitly requires clinical risk management. Clinical risk denotes any risk that could have negative effects on the outcomes for any of the quality aspects in healthcare, even if the risk factors and events itself is categorized to be non-clinical. Aspects of clinical risk management in planning, control and performance of clinical processes are integrated in this standard.

0.1.7 Healthcare specific preconditions Healthcare is characterized by numerous interactions between patients, healthcare personnel, external providers, insurers, industry and governmental bodies who shall be identified and taken into consideration. Examples of specific preconditions in healthcare are: a) Healthcare is delivered through clinical processes that are dependent on the effect/results of a number of management and supporting activities/processes. A clinical process is a continuum of care from the patient's perspective. Depending on the scope of the organization the clinical processes consist of the whole or part of the continuum of care. The results of provided processes in healthcare are mainly services where patients have interacted with healthcare personnel. b) Patient satisfaction based on needs and expectations is an overall objective in healthcare. The patient cannot always evaluate all aspects of the results of the processes in healthcare. Some aspects of the services have to be evaluated by healthcare professionals. c) It is the responsibility of the organization to support and balance between the patient's expectations and the professionally assessed needs for care. There may be differences between the expectations expressed by the patient and the patient’s needs as judged by the professionals, which has to be considered. SIST EN 15224:2017

EN 15224:2016 (E) 9 d) In healthcare there are both individual patient records, which contain confidential information about a single patient, and collated records where accumulated information on patients is collected. The protection and privacy of all such information and documentation is subject to national regulation. e) Clinical risk management is a key component in the quality management system. f) Quality and management in healthcare are dependent on reliable and unambiguous information. Information management is therefore a key component of quality management in healthcare. g) National legislation, directives and recommendations from regulatory authorities concerning healthcare services are additional to the requirements in this standard and shall be identified and taken into account. 0.2 Quality management principles This standard is based on the quality management principles described in EN ISO 9000:2015 (2.3). The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization's performance when applying the principle. The quality management principles are: — customer focus; — leadership; — engagement of people; — process approach; — improvement; — evidence-based decision making; — relationship management. 0.3 Process approach 0.3.1 General This standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4. Requirements for healthcare are described below in this clause, are specified in 4.4 and are further explored in Annex E. Understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced. Process is in EN ISO 9000:2015 defined as: “set of interrelated or interacting activities that use inputs to deliver an intended result”. In healthcare the intended results are mainly aimed to improve or maintain the health state of patients who are the main customers. The types of processes to deliver these intended results are clinical processes. The process approach in this standard is thereby focussing clinical processes as well as management and support actions influencing the directly customer oriented clinical processes. The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved SIST EN 15224:2017

EN 15224:2016 (E) 10 using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable result

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