Healthcare Services Quality Management Systems Certification according to MSZ EN 15224:2017
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General terms and conditions
On the 1st of October, 2017, the Hungarian Standards Institution published the standard MSZ EN 15224:2017 Quality Management Systems in Hungarian language. This standard is specific to the healthcare sector and its use offers additional quality improvement opportunities for healthcare provider organizations.
The requirements of this standard fully cover those of EN ISO 9001:2015, supplemented by healthcare-specific requirements, regulations, and interpretations. Important changes introduced in EN ISO 9001:2015 are reflected in the revised version of EN 15224. For instance,
- risk-based thinking is an approach running through chapters 4, 5, 6, 8, 9, and 10 of the new standard. This approach enables healthcare organizations to identify factors that might cause clinical and other processes to deviate from planned outcomes.
- New sections 4.1 and 4.2 require organizations to define factors and requirements—including services offered to patients and the quality requirements of clinical processes—that can affect the design of the quality management system.
The standard, in addition to Annexes A and B of ISO 9001:2015, presents the relationship between the sections/chapters of EN 15224:2012, EN ISO 9001:2015, and EN 15224:2016 (Annex C), thereby facilitating the transition to the revised document. A significant change is the inclusion of a new Annex D, which provides assistance in the healthcare interpretation of quality requirements and quality characteristics. Annex E visually represents in color the components of the clinical process, which forms the main process of healthcare delivery, and its interaction with other processes. An important novelty is the presentation of the clinical process model adopted from EN ISO 13940:2016, which includes the addition of values and the workflow itself.
The standard can be applied for the certification of organizations providing healthcare services, thereby helping to maintain and improve the quality and recognition of healthcare services in Hungary.
To whom do we recommend the application of the standard and the certification of the quality management system according to the standard?
According to the standard, healthcare services include, among others, the following: primary healthcare, pre-hospital and hospital care, tertiary care, nursing homes, hospice institutions, preventive healthcare, mental health services, dental services, physiotherapy, occupational health services, rehabilitation, and pharmacies. Therefore, the standard is applicable to a wide range of providers involved in healthcare delivery.
The Hungarian Standards Institution (MSZT) has professionally trained auditors and experts for certification based on the standard. The alignment of existing management systems (e.g., MSZ EN ISO 9001 and/or systems according to the Hungarian Healthcare Standards) with the MSZ EN 15224 standard can be easily achieved. We also provide joint, integrated certification for two or more management systems for our partners.
What should you do if you wish to become our client?
If you are interested in our offer, please use our provided contact details to ask for information from one of our certification managers . Or alternatively please fill out our "Request for Quotation" form and send it to us. We will welcome you among our clients with pleasure and will send you a customized quotation as a reply.
For any questions please contact us with confidence
Contact persons:
Ms. Zsuzsanna Kéki
head of certification department
phone: (+36)-1-456-6929
e-mail: zs.keki@mszt.hu
Mrs. Izabella Dávid Szamosi
phone: 06 1 456-6933
e-mail: i.david”at”mszt.hu