Since 2005, doctors, medical supply stores, psychotherapists, medical care centres, dentists and hospitals that have contracts with the statutory health insurance funds have been obliged under § 135a of the German Social Code, Book V (SGB V) to introduce a quality management system (QMS) and provide evidence of it (Federal Joint Committee).

In addition, users of a QMS have the intrinsic motivation to improve their own processes and make them more efficient (see, for example, the Federal Framework Manual for Hospices). This makes a major contribution to patient and, above all, staff satisfaction - in the health sector there is high competition for skilled staff. Due to the high cost pressure, savings opportunities through clear organisational processes and well-functioning teams also play a major role.

Certified quality management according to ISO 9001 is the best-known option here. ISO 9001 has become established, especially for medium-sized companies such as physicians in private practice, and offers more freedom than, for example, QEP (no longer certifiable, see KBV) and is cheaper in the long run than KTQ. For radiology practices, a QMS not only leads to economic success, but also helps to prevent documentation errors and deficiencies in the organisation (RWF). For providers of occupational health management and further education in the field of health, ISO 9001 is also a competitive factor.

For manufacturers of Class I medical devices or service providers (e.g. medical supply stores, orthopaedic technicians), certification of the quality management system according to DIN EN ISO 13485 or according to Directive 93/42/EEC in accordance with Annex II, V or VI is not required by law, but is increasingly demanded within the framework of contracts with trading partners or cost units. Ask our experts at Berlin Cert GmbH about this.

GUTcert offers you a high degree of flexibility as well as efficient audit planning and processing of your certification. Employees from our competent and committed industry team accompany you as your personal contact person through the entire process - from the offer to the certificate.

We are experienced in taking over certifications and are happy to support you with our change service.

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Seminars on the topic of quality management

Hospitals and medical facilities consume a lot of energy due to the high demands and produce large amounts of waste every day due to strict hygiene requirements and the use of disposable materials.

They thus contribute to fossil resource consumption and 4.4% of global emissions (HCWH) - causes of climate change. Climate change, in turn, not only burdens society financially, but also has health implications: The circle to the health economy is closed.

Environmental management aims to save resources, CO2 emissions and thus also costs. Within the framework of the BMU's national climate protection initiative, initiatives in the direction of environmental and climate management are promoted (KLIK green).

The requirements that German environmental laws place on business are particularly high. A certified environmental management system according to ISO 14001 is a step in the right direction.

European environmental management according to EMAS ("Eco-Management and Audit Scheme") is considered one of the most demanding systems for sustainable environmental management worldwide. Since 2015, hospital companies have been obliged by the § 8 ff. EDL-G, hospital companies have been obliged to make energy efficiency improvements, for example in accordance with ISO 50001 or EMAS.

Companies that undergo validation according to EMAS are actively protecting the environment and making their activities visible to the public. At a time when the issue of sustainability is increasingly coming to the fore, validation according to EMAS becomes a real competitive advantage.

Some companies have been accompanied by GUTcert for over a decade and to this day the employees in the companies are motivated and: "They are looking for improvement possibilities themselves and don't just want a certificate on the wall", said environmental verifier and managing director of GUTcert Prof. Dr. Jan Uwe Lieback already in 2008 about his experiences at IMD Labor Oderland GmbH.

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Seminars on environmental management

In Germany there are almost 2,000 clinics with about 500,000 hospital beds (Statista). Rising costs in the healthcare sector are offset by opportunities for cost savings in energy consumption. Since 2015, hospital operations have also been obliged by the § 8 ff. EDL-G to increase energy efficiency, for example with a certified energy management system according to ISO 50001 or EMAS. The energy audit according to DIN EN 16247-1 as a further option is not suitable for hospitals and clinic groups, as the so-called multi-site procedure with random sample audits is not applicable here:

Excerpt BAFA leaflet for energy audits (page 19):
"The application of the multi-site procedure is not suitable due to the complex and differentiated given technical infrastructure, e.g. for the hospital sector or for production facilities."

Excerpt BAFA Guideline for the preparation of energy audit reports according to the requirements of DIN EN 16247-1 (page 56):
"Clusters of, for example, production facilities or hospitals cannot be formed, as no clear comparability in the cluster can be guaranteed for these facilities. In such cases, it is not possible to transfer the results from site investigations to the remaining sites located in the cluster in the context of comparability."

Companies that decide to implement an energy management system according to ISO 50001 can, under certain conditions, claim subsidies (including for consulting, staff training, certification costs) of up to €20,000.

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Seminars on the topic of energy management

Digitisation in the health sector is associated with tele-medicine and e-health, but not only patient data is available digitally, but also quality, energy and environmental management are based on digital infrastructures. Hackers are increasingly penetrating structures in the healthcare industry. Cybercrime often involves disseminating highly sensitive medical data or encrypting data and demanding a ransom for the (uncertain) release of the data (Situation Report BSI 2020).

"Medical care" is considered Critical Infrastructure for Information Security and thus falls under the KRITIS §8a regulation. This means organisations must prove to the Federal Office for Information Technology (BSI) that they have a functioning information security management system. Industry-specific security standards (B3S) form the basis of this audit. However, this proof can also be provided by certification according to ISO/IEC 27001 certification. ISO/IEC 27001 is the internationally recognised standard for information security and provides a comprehensive framework for implementing measures to protect the highly sensitive IT systems in hospitals.

Even hospitals that are still below the current threshold of 30,000 cases per year should address information security, as the threshold is expected to be lowered in the coming years. First steps in doing so are:

• introduce an appropriate organisational structure
• Identify all critical patient care processes
• identify and document all relevant assets (IT infrastructure, procedures and information)
• Identify and assess risks to IT assets
• Introduce business continuity management
• implement an appropriate information security management system (ISMS).

The more of these steps are already implemented, the easier it will be to operate a KRITIS-compliant ISMS later on.

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Seminars on information security and data protection

It does not matter whether they are training centres for health professions, rescue service schools, medical schools for geriatric care or nursing schools at hospitals: Anyone who wants to offer services subsidised by the Federal Employment Agency or participate in tenders of the employment agencies and job centres needs to be accredited as a provider. All labour market service providers who want to offer services funded under SGB III must have a licence in accordance with the Accreditation and Licensing Ordinance (AZAV).

We have compiled all the important information on the certification process on our page on provider accreditation. Once the requirements for AZAV approval have been met, all that remains is to obtain approval for a specific measure in order to be able to implement subsidised CVET measures (subsidised through the education voucher) or activation measures (subsidised through the activation and placement voucher). We provide information on the procedure on our page on the approval of measures.

Further information on the accreditation of training providers and measures (AZAV - SGB III).

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AZAV: Basics and current topics

If the different requirements are combined in an integrated system approach, this minimises the overall effort required to set up and maintain the entire management system. Through process-oriented auditing of several management systems at the same time, various synergy effects can be used. Price advantages of up to 50% compared to separate processing of the individual procedures are not uncommon.

EcoStep - Integrated Management System incl. Quality, Environment and Occupational Safety

Service providers in the health care sector are particularly competitive. EcoStep supports small and medium-sized enterprises such as maternity clinics or training providers in the health sector in a practice-oriented and compact way to operate sustainably and in a legally compliant manner and to save resources at the same time. It covers a freely selectable combination of core elements of the following ISO standards:

Quality management according to ISO 9001
Environmental management according to ISO 14001
Occupational health and safety according to ISO 45001

EcoStep increases the importance of your company in the market, customer and employee satisfaction and saves costs through efficient organisation.

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Seminars on the topic of integrated management systems