THE NEW ISO 9001:2015: A STEP CLOSER TO SUSTAINABLE INTEGRATED MANAGEMENT IN HEALTHCARE Claus Nagel-Picioruș1, PhD Candidate Luciana Nagel-Picioruș 2 and Prof. PhD Roxana Sârbu RNR AG; Head of Organisational Development and controlling 2) 3) Bucharest University of Economic Studies Claus Nagel-Piciorus - 27.02.2015

Structure of the presentation 0. Research problem Integrating approach in a German healthcare organization Norm-based Elements of an integrated management system (IMS) Basic models behind an integrated management and reporting system Online survey about “state of the Art” of IMS in healthcare organizations in Europe Structured Interview in healthcare organizations Methodological design: case study of RNR ´Radiologische Netzwerk Rheinland´ Development of the IMRS project in the RNR Group Decision of the Board Members Expanding Risk Management to the operational parts Integrating the different management systems in a unique system Connecting and aligning the IMS-system with the strategic planning process Implementing the integrated reporting system Proposal of key performance indicators / cross-impact-analysis Conclusions and contribution to the science

0. Research problem There are different concepts of an integrated management system in the management literature and in practice. Challenges: Different systems cover only some aspects of management and exclude other important ones. Legal requirements in healthcare organizations increase, requiring a completely integrated approach. Norm-based management systems are very similar to each other and easy to integrate, though they are mainly used as separate single systems. Also, like ISO 9001, they often have no connection to the financial and strategic business planning process; Existing controlling systems, like the BSC, are often disconnected to existing norm-based management systems like ISO 9001. Possible solution: For the implementation of an integrated reporting like the IIRF, it is necessary also to have an integrated management system.

What is an integrated management system? Working on a new definition of integrated management system followed by an implementation process in steps and at diverse organizational levels: First level points at the incorporation of all essential norm-based management systems within a healthcare business into one single integrated management system. Second level entails the integration of IMS into the strategic planning process by using a balanced scorecard – BSC. Finally, BSC becomes a reliable foundation for internal and external reporting, upgrading to the third level of integration. Our definition: an IMRS makes use of minimum norm-based management systems - Quality management system, Risk Management system, Knowledge Management, IT- Security management, Health and safety management and Environmental management, interrelated through the strategic planning via Balanced Scorecard and published through an integrated reporting system.

1.1 Norm-based elements of an Integrated Management System (IMS) Quality Management (ISO 9001) Risk Management (ISO 31000 / ONR 49000) Quality Management (ISO 9001:2015) Knowledge Management QM in healthcare (DIN EN 15224) IT-Security Management (ISO 27001:2013) Health & Safety Management (OHSAS 18001:2007) Environmental Management / EMAS (ISO 14001:2007)

1.2 Other basic models & concepts behind an IMS in the theoretical framework Strategic Management (Drucker 2006), (Wren ©1994) Business Strategy (Ansoff 1968), Strategy & Structure (Chandler 2013) EFQM Balanced Scorecard (Kaplan und Norton) / Strategy Maps (Kaplan und Norton ©2004) Norm-based management systems System Dynamics (Forrester 2013) / Cross-Impact Analysis Intellectual capital management ( Oleksak und Oleksak 2010) Key performance indicators (Parmenter op. 2010) Integrated Reporting (Eccles und Krzus 2010) International Integrated Reporting (International Integrated Reporting Council (IIRC) 2013) Learning Organization (Senge 2006) Continuous improvement process / capability maturity model integrated (CMMI) (Forrester et al. 2010)

Overview of relevant literature Ansoff, H. Igor (1968): Corporate strategy. An analytic approach to business policy for growth and expansion. Harmondsworth, Middlesex, England: Penguin Books (Library of business and management). Chandler, Alfred Dupont (2013): Strategy and structure. Chapters in the history of the industrial enterprise. Mansfield Centre, Conn.: Martino Publ. Drucker, Peter F. (2006): The practice of management. 1st Collins ed. New York, NY: Collins. Eccles, Robert G.; Krzus, Michael P. (2010): One report. Integrated reporting for a sustainable strategy. Hoboken, N.J: John Wiley & Sons. Online available under http://www.worldcat.org/oclc/607552730. Forrester, Eileen C.; Buteau, Brandon L.; Shrum, Sandy (2010): CMMI for services. Guidelines for superior service. Upper Saddle River, NJ: Addison- Wesley (The SEI series in software engineering). Forrester, Jay Wright (2013): Industrial dynamics. [Reprint of First Ed. 1961]. Mansfield Centre, Conn.: Martino Publ. International Integrated Reporting Council (IIRC) (2013): The International <IR> Framework. Kaplan, Robert S.; Norton, David P.: The balanced scorecard. Translating strategy into action. Kaplan, Robert S.; Norton, David P. (©2004): Strategy maps. Converting intangible assets into tangible outcomes. Boston: Harvard Business School Press. Oleksak, Mary Adams; Oleksak, Michael M. (2010): Intangible capital. Putting knowledge to work in the 21st-century organization. Santa Barbara, Calif.: Praeger. Parmenter, David (op. 2010): Key performance indicators. Developing, implementing, and using winning KPIs, second edition. Hoboken: John Wiley & Sons. Senge, Peter M. (2006): The fifth discipline. The art and practice of the learning organization. Rev. and updated. New York: Doubleday/Currency. Wren, Daniel A. (©1994): The evolution of management thought. 4th ed. New York: John Wiley.

The current status of the models Quality Management Quality Management external reporting Balanced Scorecard Balanced Scorecard Integrated reporting <IIRI> Risk Management Risk Management Safety Management Safety Management Internal reporting Knowledge Management Knowledge Management Integrated management systems (IMS) like TQM, PAS 99, ISO 9001:2015 Controlling System Controlling System Management Reporting Management Reporting

Comparisson between BSC and ICR ICR: kinds of capital BSC dimensions reporting concepts financial financial reporting relational capital customer non-financial reporting structural capital process human capital learning & growth

Different reporting perspectives External reporting of the past (e.g. Classic financial report) External reporting of the future (e.g: IIR) External Internal reporting of the past (e.g. controlling report) Internal reporting of the future (e.g. ICR) Internal Past Future

4. Methodological design: case study of RNR group To accompany the implementation of an IMS in a German healthcare organization - RNR AG, a service provider for radiology and ray therapy services in Germany, with 1100 employees. The company plans to implement an Integrated Management and Reporting system during the next years.

4. Methodological design: case study of RNR group The research instrument which offered the possibility to collect comprehensive data on a large healthcare company >> descriptive case study (Yin, 1984): It allows working with data relevant for a particular healthcare market; a complementary research for expanding the conclusions for the European healthcare sector follow: questionnaire and semi-structured interviews.

5. IMS Model (version 1.0) Development of the IMRS project in the RNR Group Decision of the Board Members Expanding Risk Management to the operational parts Integrating the different management systems in a unique system Connecting and aligning the IMS-system with the strategic planning process Implementing the integrated reporting system

Ressourcen / Human Ressources Structure/ Technical Systems 5. IMS Model (version 1.0) Policy Leadership / Culture Plan Do / Process Check & Report Act & Learn Finance Mission Vision Strategy Values Results Goals Customers Processes Ressourcen / Human Ressources Structure/ Technical Systems IMS-Model ver. 1.0

The core matrix of the model Quality Risk OHSAS EMAS Plan Finance Do Check Act Results Customers Processes Employees / Resources

Quality Management (9001:2015) Impact of the new ISO 9001:2015 proposal on quality management in health care Main aspects of the new porposal: The new proposal also contains Risk Management and Knowledge Management. This proposal is now an important step towards an integrated management system Because of different scandals in healthcare to focus of the ISO 9001:2015 will be very much on risk management With the new proposal of the ISO 9001:2005 the DIN EN 15224 will lose importance in healthcare With the ISO 9001:2015 on the one hand an other controlling and reporting initiatives in healthcare on the other hand, there will be the need for an integrated management system Quality Management (9001:2015) Quality Management Risk Management Knowledge Management Quality Management in Healthcare (15224)

7. Conclusions and contribution to the science The scientific literature and empiric research warranted the affirmation of insufficient works on an integrated norm-based management system (Jorgensen, 2006) and an integrated reporting model in healthcare (Bisbe, 2012). The new proposal of the ISO 9001:2015 with its ‘high-level-structure’ and the new components will be an important step towards a more integrated management system in all business areas. Contribution to the science Theory on Integrated Reporting Management Systems: IMRS general framework a distinctive definition of integrated management system, based on three-incorporation levels approach, followed by an implementation process in steps and at diverse organizational levels, connecting it to the practical relevance of this study. Practical implications: important part of the findings will compare real benefits and issues dealt with during the implementation process, and draft a proposal for a IMRS blueprint based on the German experience.

7. Conclusions and contribution to the science An extension of the research could answer the question of transferability to other business areas, and asses the concrete savings of an IMRS for a company. In my opinion, such an integrated model is indispensable to handle the increasing requirements for healthcare businesses, dealing with rising costs, quality information and rankings of institutions contributing to forceful competition because of globalization, extra regulation due to quality issues, increasing risks and hygienic problems. >>> An integrated model can help competently managing all these aspects.

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