Increased leadership requirements

"Through increased leadership requirements (employees, context, strategy, process management, result orientation, integration), the QMS is integrated more sustainably into the organization. As a result, key success factors of an organization operating a QMS according to ISO 9001 are more systematically integrated into the management work (SC 5.1). The focus for a QMS with the greatest possible impact is on:

The accountability for the suitability and effectiveness of a QMS lies as a non-delegable task with the top management. It creates the essential conditions that the concepts required in a QMS are suitable and effective with the employees behind them, i.e. that the intended results are achieved. The top management actively lives this commitment. The 10 points relevant to success are specified as requirements in the standard.

Employees are responsible for quality at all levels and produce it every day. Therefore, one of the 10 leadership factors deals with this success factor "employee empowerment & inclusion". Factors from the organization's environment change more dynamically and not always according to plan. Thus, the importance of timely recognition of risks and opportunities regarding intended or possible changes to short- and longer-term business results increases (see part 1). The inclusion of context and strategy in QMS planning is a new requirement. This obliges a longer-term view and corresponding QMS planning. Top management ensures that QMS planning is in line with the strategic direction of the company and the context and takes account of developments and changes in this regard.

The operator of a QMS has a high degree of freedom in determining, designing and documenting the processes. However, he is not free to ensure that the defined processes are appropriate and fully effective. The freedom built into the ISO standard makes it possible, in today's dynamic and diverse business models, to operate a QMS in accordance with ISO 9001 appropriately and efficiently. ISO9001 requires the integration of QMS requirements into processes.

Instruments for meeting the requirements of the standard

The classic instruments such as quality policy, mission statement, vision/mission, management principles, principles of internal communication, process landscape as well as organisation chart, job/function descriptions, task matrix etc. are supplemented for this purpose in the following. The supplementary instruments represent possibilities and suggestions for implementing the standard requirements, but do not claim to be the only possible ones or to be mandatory in this form. An extended management review is an effective instrument for fulfilling the increased leadership requirements of Chapter 5 of the standard (SC 5). Customer results, employee results, system performance, process performance and economic success as a result of the organization's activities (NK3.6.8) are used as a closed PDCA (Plan, Do, Check, Act) loop to achieve the organization's goals. With the help of the context-relevant trends, SWOT etc. described in Part 1 (April issue of Management& Quality), closed management control loops result as a management activity from the strategic level to the operational activity (Cf. Fig.1).

The management review as a management tool

"By systematically assessing changes in context, risks and opportunities, and quality objectives, the organization is able to take timely action" (NC 9.3). The management process should be a closed loop of strategic management, operational management and the annual management review, where the review aims to analyse the effectiveness of management activities. Against the backdrop of strategy and policy, customer outcomes, employee outcomes, business process performance, system performance, and business success are ideally measured, and goals and actions are derived and prioritized from them. Since a snapshot of the aforementioned factors does not allow for a well-founded analysis, the course of the data obtained should be documented over several years. With such a requirement, the ISO 9001 model approaches the representations in the results section of the Business Excellence Model of the European Foundation for Quality Management (EFQM).

Identify customer needs

"By systematically addressing risks and opportunities, nonconformities can be avoided, processes improved, and customer and stakeholder satisfaction sustainably increased." (NK 3.26/3.57/ 4.2/5.1.2/9.1.2) The classical approach often captures customer satisfaction, but not the weighting of customer needs. Both factors are important for prioritizing measures. It makes little sense to use more resources for the improvement of needs that are less important for the customer. A graphical evaluation of the survey statistics, which reflects both components, makes it possible to identify focal points for measures at a glance. In a matrix with the axes "satisfaction" and "weighting", the perpendicular distance of a measuring point from the diagonal is a measure of the need for action. In very simplified terms: the greater the distance from the diagonal in the case of underperformance, the sooner a measure should be considered. When formulating the questions, it is advisable to carry out a pre-test in cooperation with selected customers so that the needs of the customers can be recorded both comprehensively and precisely and the usability of the procedure is ensured.

Future needs are difficult to determine through surveys. It is important to understand the process of using a product or service. Opportunities are offered by in-depth contacts with customers (lead user approach) or observation through shadowing. The goal is, among other things, to gather ideas for better meeting customer needs. Ideally, new needs not yet expressed by the customer can be derived. Depending on the business activity, it is also advisable to act specifically according to customer loyalty segments when taking measures to record and implement customer needs. Depending on the duration, intensity and future potential of customer activities, different goals and needs may emerge.

Promoting employees

"By involving employees and external contractors, awareness is raised regarding their own contribution to quality performance and possible consequences of non-compliance" (NC 7.3).

The implementation of employee satisfaction surveys is not explicitly required by the standard. However, in SC 5.1 (Leadership) and in Annex C, reference is made to the fact that the inclusion and competence of employees apply to all chapters of the standard. The identification, development and evaluation of the knowledge, skills, behaviour and working environment of employees is required (SC 4-10). With ISO 10018, a separate standard is published for this purpose. A benefit-oriented employee survey (incl. degree of fulfilment and weighting of the criteria) for employee development therefore makes perfect sense. For these surveys, what has already been said under "Recording customer needs" applies (cf. Fig. 2). Impulses for future required knowledge, skills, behavior and possibly also a changed work environment result not only from the input of the customer side, but also from the findings of the analysis of the company context presented in Part 1.

Measure system performance

"Through integrated planning of internal audits, the organisation uses them as a management tool to continuously improve customer satisfaction and organisational results" (SC 9.2). System performance is normally determined on an annual basis through internal audits or external audits by a certifying body. Even if a documented procedure (or written process) for internal audits is no longer required, documented information on the implementation of the audit programme and its results shall be kept. Furthermore, it is possible to conduct an external assessment according to the EFQM's "Committed to Excellence" or "Recognised for Excellence" approach (offered in Switzerland, for example, by SAQ, Bern). A questionnaire of the SwissBex initiative on the homepage of the SAQ allows an internal short assessment. An intermediate stage is offered by certifying bodies in the form of a combination of the audit according to ISO 9001 with an extension of the aspects of ISO 9004.

Orientate on results

"Through detailed planning, the organization ensures that relevant management information can be provided at the right time and with the right quality." (NC 9.1). It makes sense to include business management data in the review. Linking financial data to analysis on the customer, people, system, and process sides allows for the derivation of important cause/effect relationships. At a minimum, revenue, costs, and cash flow (simplified as the sum of profit and depreciation) should be presented. If absolute figures are not desired, relative development can be used. Here the turnover of a certain year is set to 100 % and the factors, also over time, are related to this. The operational data on customers, employees, processes, economic results and improvement activities can be combined in an operational cockpit as part of the management review. A balanced scorecard or analogous approaches serve as a guide to the progress of strategy implementation.

Better understanding of realities and complex cause-effect relationships

"By systematically collecting, analyzing and assessing data, the organization creates a solid basis for better understanding operational realities and complex cause-and-effect relationships, and for making the necessary decisions with greater objectivity and confidence. " (NK 9.1.3)

A particular challenge is the recognition of the levers and complex mechanisms of action of a system. The method of networked thinking with the graphical illustration as a relation diagram is suitable for this. The type (positive, negative) and strength (weak, medium, strong) of the influences as well as the reaction speed (short-, medium-, long-term) can be shown (cf. Fig. 3). Another method is the use of decision trees.

lead improvement

"Successful organizations have a strong focus on continuous improvement - because improvement is essential to maintain current levels of performance, to respond to changes in the context of the enterprise, and to seize new opportunities and possibilities." (NC 10.3) The importance of closed improvement loops according to the PDCA approach is underlined by a separate chapter (NC 10). The relevant methods of permanent improvement are sufficiently well known. However, the less frequently used Failure Mode and Effects Analysis (FMEA) or Quality Function Deployment (QFD) are also useful. The visualization of concrete goals, ongoing activities and achieved results (storyboard approach) is important for the leadership - and especially self-leadership - of teams and employees. Visualization also supports the transfer to other teams, processes or areas of the organization.

Document the system

The revision of the standard was used to focus on the effectiveness and strategic benefit of a QMS (see text box "Intended results of a QMS according to ISO 9001"). Document requirements come into play where actually necessary and suitable. Factors such as the type and size of the company, complexity, business model, competence & knowledge, degree of control of the processes, reliability of evidence, expectations of interested parties, own objectives such as communication, awareness raising, access to knowledge, etc., all play a role (SC 7.5.1).

By using the term "documented information" instead of "documents", independence from the medium used is signalled, among other things. Required documented information is explicitly mentioned at the end of each chapter of the standard, where ISO 9001 specifically expects confidence in the management of the relevant business activity or in the record keeping. It is the responsibility of the user - tailored to his organization - to determine and ensure the appropriate level of documented information.