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EN 15224 "Health care services. Quality management systems. Requirements according to EN ISO 9001: 2008 "
This European Standard:
• Provides a systematic approach to the organization's ability to provide good quality health care services;
• It can be used at all levels by the management of the health care organization to establish and maintain a quality management system, or internal and external parties, including certification bodies, to assess the organization's ability to meet the needs and expectations of the patient as well as other clients;
• It applies to healthcare organizations regardless of their structure, structure, owner, size, or type of healthcare provided
• It applies, for example, to primary care, to in-patient and in-patient care and third-level care facilities, nursing homes, incurable sick nursing hospitals, preventive health care, mental health care, dental services, physiotherapy and occupational health care services and pharmacies;
• It focuses on the requirements of clinical processes. Organizations that also carry out research or training processes, when applying their quality management system, may, if appropriate, apply the requirements of this standard. If any of the requirements of this European Standard can not be applied due to the nature of the healthcare organization or its product (including services), it may be disregarded. In the event of non-compliance with the requirements, declarations of compliance with this European Standard are not acceptable unless the requirements of Chapter 7 are disregarded, and failure to comply with such requirements does not adversely affect the ability or responsibility of the healthcare organization to supply products (including services) that are in accordance with the customer and applicable laws and regulations Requirements of the legislation.
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