3.1.12 Management assessment Estimated reading: 7 minutes 53 views Authors 1 Aim and purpose Formal assessment of the condition, effectiveness and appropriateness of the QM system with regard to quality policy and quality objectives. 2 Application Annual evaluation of the effectiveness of the QM system as a whole and the subordinate QM systems by the top management. Definition of quality objectives for the following year. 3 Description 3.1 Information for the evaluation 3.1.1 Status of measures from previous management assessments (preventive and corrective measures) The processing status of corrective actions, including the follow-up of previous management reviews. 3.1.2 Changes in the context of the organisation Discussion of external and internal issues affecting the quality management system, including its strategic orientation; possible revision of the quality policy. Changes in the requirements and expectations of interested parties. Changes in legal requirements and other recognised regulations. 3.1.3 General reports At the end of each year, the QMK compiles information that is important for the evaluation of the QM system. This may include reports such as - Management report of the company - Reports from managers and supervisors - Performance data (process performance and product conformity) from, for example the quality report or medical controlling data, clinical indicators including morbidity and mortality - results of monitoring and measurements including the results of comparative quality assurance in accordance with Section 137 SGB V - changes in the range of services or changes in the scope and type of activities carried out (new treatment procedures, List of complaints - List of liability cases - List of adverse event reports - Patient survey (patient satisfaction) - Clinical case studies - Comparisons with other facilities - Feedback from registers (cancer register, MP register) - Suggestions for improvement measures 3.1.4 Internal audits The QMK summarises the results of the year's audit reports. Individual points can be emphasised: - Hidden weaknesses - Need for correction - Reliability of the organisation - Degree of penetration of the organisation by the QM system - Changes in the process workflows - Need for revision of procedures and work instructions The audit results can be prioritised according to the audited areas, e.g. - Compliance with ethical principles - SOPs for regularly recurring processes - Use of suitable test equipment - Qualification of personnel - Archiving - Checking compliance with the above points through in-process quality control (to check process stability) - Checking through in-process auditing 3.1.5 Reports to the Management Board The reports submitted to the Managing Director during the course of the year, particularly those of the managerial and supervisory staff, are scrutinised for important content. 3.1.6 Changes with an impact on the QM system New or revised legal or other normative requirements, changed product and performance requirements and the status of competitors that could give rise to changes in the QM system should be proposed. 3.1.7 Assessments by external bodies Inspection reports by the public health department Results of external audits (e.g. certification audit) Results of comparisons (e.g. external quality assurance in accordance with § 137 3.1.8 Information feedback from customers Not every reference by the customer to extended or changed requirements are complaints - they should nevertheless be used to improve the service. 3.1.9 Collection of complaints (claims) Complaints or grievances received between two internal audits are collected and analysed by the QMK after they have been processed by the department handling the complaint. The collection of customer feedback should be very broad and include not only complaints, but all complaints and feedback, including those from employees 3.1.10 Overview of "Undesirable events" (errors) Results of the evaluation by the QMK in accordance with the requirements of the VAs in section 5.4, including assessment of the effectiveness of measures to address risks and opportunities 3.1.11 Personnel development measures Records of staffing plans, competences, training requirements, staff development: staff departures and replacements should be updated 3.1.12 Overview of training measures The management assessment should include considerations as to whether measures need to be taken for the further education and training of employees. The identification of training needs for the current year can be linked to the management review. The department's training plan should be coordinated with the programme of other institutions. A list of all training events should be available in the secretariat for this purpose. 3.1.13 Supplier evaluation The supplier evaluations should be summarised. Doubts about their performance should be pointed out. 3.1.14 Obtaining further training authorisations There are guideline figures for examination and treatment methods for further training authorisations. Each year, the evaluations should be used to check whether an authorisation for further training is at risk. 3.1.15 Recommendations Recommendations for improvements, including technical requirements (space, equipment, materials). New potential opportunities for continuous improvement. Introduction of new procedures, innovations in the specialities. 3.2 Report on the quality situation to the management A report is prepared for the Managing Director based on the results of the reports and the systematic audit. The report is formally accepted by the Managing Director. The report should contain a proposal for corrective measures, improvements and new quality objectives. The report can also be presented in the form of a conversation and its core statements recorded.edit 3.3 Management assessment The management review is carried out in a joint meeting of the company management, possibly chaired by the managing director, other consulted managers and the QM coordinator. The QM coordinator's report(s) should be noted and discussed. The continued suitability, appropriateness, effectiveness and functionality of the QM system must be evaluated, in particular the suitability of the basic regulations, procedures and measures for quality control. Top management must check whether changes need to be made to the quality policy and the overarching objectives. The need for change in the QM system, in particular the quality policy and quality objectives, must be determined.edit 3.4 Evaluation results 3.4.1 Corrective measures Based on the report, a corrective action plan is drawn up for all deviations identified. The timeframe for rectification should be determined - which ones can be rectified immediately? If this is not possible - whether operations need to be restricted. For which issues quality teams may need to be set up. Whether extensive investment is required to rectify the defects? Whether corporate policy aspects should be taken into account. 3.4.2 Improvement measures The management must decide whether changes to the QM system and its processes are necessary. This also applies to clinical processes (treatment patterns): have customer requirements changed? Are there new approaches to treatment procedures? Do they need to be reorganised and improved due to new findings and additional requirements? 3.4.3 Resources If measures are required to improve the conformity of services or changes are made to clinical processes, the necessary resources must be identified and made available. Changes in infrastructure such as water, energy supply, IT, waste disposal, refurbishment requirements (facilities, construction projects) should be defined. The need for changes in resources for the QM system is to be assessed. 3.4.4 Training programme The training requirements are to be assessed and a training plan adopted. 3.4.5 Occupational safety Further development of occupational safety 3.4.6 Hygiene Further development of hospital hygiene 3.4.7 Risk management Financial risks, performance risks and potential disruptions with an impact on treatment processes, particularly in terms of patient safety, the need to change processes in order to reduce or eliminate the risks identified. 3.5 Special features in special QM systems In the management assessment of the individual subordinate QM systems (e.g. laboratory, pharmacy, sterile supply), their special features must be taken into account. If the management assessments are carried out separately for the QM systems, their results must be included in the company-wide management assessment. 3.6 Quality development plan A quality development plan should define which corrective measures are to be implemented before the next internal audit, who will carry out the corrective measures and what time frame will be set. All further measures are integrated into the plan. 4 Documentation Report of the QMK to the Managing Director Minutes of the management review with documentation of the management's decisions Quality development plan for the following year 5 Resources 1 day for collating the findings 1 day for evaluation and setting quality targets The QMK should be given one week each year to evaluate and prepare the report. Approximately 3 - 4 hours should be available for the presentation of the assessment and consultation with the head of department, including the preparation of the quality development plan. 6 Responsibility, qualification Participants in the management assessment: Operations management (medical director, nursing director, head of administration), possibly head of technology, other clinic directors and the heads of the areas that have set up their own QM system (laboratory, pharmacy, sterile supply), QM coordinator, managing director Management assessment: Managing Director Summarised report, quality development plan: QMK Informing staff about the results: Management 7 Notes and comments 8 Applicable documents 8.1 Literature DIN EN ISO 9001:2015 DIN EN 15224:2017 DIN EN ISO 17025:2005 DIN EN ISO 15189:2013 DIN EN ISO 13485:2012 DIN EN ISO 19011:2011 8.2 Terms 9 Systems Management assessmentDownload Minutes of the management review with documentation of the management's decisionsDownload Quality development plan Status note Hamburg, 2.9.2005, U. Paschen, updated and extended: 8.10.2008; 18.05.10; 18.11.12; 27.01.14 Version 5; 20.10.15 Update according to ISO 9001:2015 3.1 Responsibility of the management - Previous 3.1.11 Conference for quality management Next - 3.1 Responsibility of the management 3.1.13 General Terms and Conditions
