Introduction and summary of clause 5 of ISO 9001

Clause 5 of the ISO 9001:2015 standard deals with the leadership and commitment of top management within the framework of the quality management system. This clause highlights the crucial role that managers play in promoting the success of an organization. Before we look at the requirements of Clause 5 in detail, here is a brief explanation of some important terms: In ISO 9001, organization refers to a company, firm, group, corporation, authority or institution, or parts or a combination thereof, which has its own functions with responsibilities, powers and relationships to achieve its objectives. This can be a public or private company. Top management is the person or group of people who manage and direct an organization at the highest level. This is usually the management, the board of directors or the owner of a company. Top management has overall responsibility for the quality management system. In the context of ISO 9001, documented information means all documents, records and data that are relevant to the quality management system and must be managed accordingly. Interested parties are all internal or external persons or organizations that have an interest in or influence on the QM system, such as customers, employees, suppliers or authorities. Top management bears overall responsibility for the effectiveness of the quality management system and must demonstrate the importance of quality objectives through its commitment and active involvement. Key tasks include defining the quality policy, integrating the requirements of the management system into the core business processes and promoting a customer-centered approach. By fulfilling this management responsibility, top management creates the basis for the successful implementation and maintenance of a quality management system that focuses on continuous improvement and customer satisfaction.

Clause 5.1: Leadership and Commitment

 

Clause 5.1.1 General understanding of the leadership role

Summary

The aim of clause 5.1.1 is to ensure that the top management of an organization demonstrates leadership and commitment to the quality management system (QMS). The standard requires a visible and active commitment from the management level to ensure and continuously improve the effectiveness of the QMS.

What does that mean in concrete terms?

Effective quality management requires committed leadership. One of the most important prerequisites for the success of a QMS is active and visible leadership and support from the top management body. ISO 9001 defines specific tasks for this in Clause 5:

1. Take responsibility: As the highest authority in the organization, overall responsibility for the performance and effectiveness of the QMS lies with the management. It must regularly report on the current status and results of the QMS and take corrective action in the event of deviations from the objectives.
2. Define appropriate quality policy and objectives: The management defines the overarching quality principles and the specific objectives for the QMS (see requirements in clause 5.2). These must match the strategic direction and long-term goals of the organisation. The objectives must be formulated SMART (specific, measurable, accepted, realistic and time-bound). The management must actively work towards these goals. Further requirements are described in clause 6.2.
3. Ensure integration of QM requirements: The management is responsible for ensuring that the requirements of the QMS are incorporated into daily procedures and processes. This applies to all areas – from product development to production and sales. QM must not be operated as an isolated system.
4. Regular review of performance and results: The management must regularly review the performance, effectiveness and results of the QMS in management reviews (see clause 9.3 for management review requirements), e.g. using key performance indicators, audits (see clause 9.2 for further requirements) and customer feedback. Tasks are often delegated to a QMB. The QMS is adapted as required.
5. Deploy, train and support employees: Employees must be given the right tasks, responsibilities, authorisations and training to perform their roles in the QMS optimally and contribute to its success.
6. Identify potential for improvement: Potential and opportunities to improve quality and QMS must be actively addressed and realized by the management. Clause 10 describes further requirements.
7. Involve other managers: All managers in the organization are involved by the top management in their responsibility for quality management in their area and are encouraged to provide active support.

How can this be implemented in practice?

In order to implement the requirements of clause 5.1.1 of ISO 9001:2015 in practice and to credibly demonstrate the leadership and commitment of top management, the following measures are recommended:

• Regular personal communication of the quality policy and objectives by the management, e.g. in meetings, training sessions or video messages. In this way, the strategic focus on quality is exemplified.
• Actively participate and lead senior management in key QM activities such as management reviews, internal audits, risk assessments and improvement projects.
• Integration of quality targets into the target agreements and performance appraisals of managers in order to strengthen their commitment.
• Provision of sufficient resources (budget, personnel, infrastructure) for the QM system to enable its effective implementation and further development.
• Recognizing and honoring employees who are committed to quality improvement, e.g. through awards, bonuses or public recognition.
• Promoting an open error culture in which problems are addressed openly and seen as opportunities for improvement.
• Regular review of quality performance and derivation of improvement measures by top management as part of the management reviews.
• Training for managers to convey their role and responsibility in the QM system and to strengthen their ability to promote quality.

It is crucial that the support and commitment to the QM system is demonstrated authentically and credibly by the management level. Only in this way can a culture of quality take root in the company. Employees are strongly guided by the behaviour and priorities that managers convey through their actions, and by consistently living the quality values, top management creates the conditions for the QM system to be supported and lived by all employees. A credible commitment from management is the key to the sustainable success of the quality management system.

Clause 5.1.2 Customer orientation – a central management task

Summary

The objective of clause 5.1.2 is to ensure that the top management of an organization identifies, understands and consistently meets customer, legal and regulatory requirements. Die Norm betont die Bedeutung der Kundenorientierung als Kernaspekt eines wirksamen Qualitaetsmanagementsystems.

What does that mean in concrete terms?

Specifically, the top management must: Determine and understand customer requirements The aim here is to systematically record the specific and sometimes unspoken expectations and needs of customers. This can be done through direct customer contact, surveys, or analyzing complaints. It is important to recognize not only obvious product requirements but also “soft” factors such as delivery reliability, information and customer service. Understanding customer requirements is a prerequisite for their fulfilment. Know and fulfil legal and official requirements Compliance with legal requirements and official regulations is essential for every company and part of customer orientation. Management must introduce processes to recognize new regulations and ensure compliance. Ensure that customer requirements are met Management must ensure that customer requirements are translated into appropriate products, services and processes. The fulfillment of customer expectations must be a central objective. Keeping an eye on risks and opportunities Potential risks and opportunities concerning product conformity and customer satisfaction should be systematically analyzed and evaluated (see clause 6.1). The management must ensure their proactive control. Creating a customer-orientated quality policy The management must establish a quality policy in accordance with clause 5.2 that focuses on the customer and the fulfillment of their requirements. This policy forms the framework for the specific QM work. Manage customer relationships effectively Beyond the mere fulfilment of requirements, the management must also focus on maintaining customer relationships. Regular contact and cooperation based on partnership lead to customer satisfaction and loyalty. Exceeding customer expectations Wherever possible, customer satisfaction should be ensured, e.g. through particularly high quality, additional service and innovations. Management must create an organization that promotes the pursuit of excellence for customers. The implementation of these aspects forms the basis for continuously anchoring and improving customer orientation and customer satisfaction within the organization. ISO 9001 calls on management to make a genuine commitment here, as this is a key factor for quality and company success.

How can this be implemented in practice?

To effectively capture and understand the requirements and expectations of interested parties, organizations can use different methods depending on their industry and business model. Companies that handle customized projects or orders, such as in mechanical or plant engineering, will often detail the requirements in several steps. Starting with a rough recording of the customer’s requirements in the quotation phase, the specifications are refined and harmonized as the project progresses. Manufacturers of series products or consumer goods for the broad market, on the other hand, often rely on extensive market analyses. Target groups, competitors and the company’s own product portfolio are analyzed in order to anticipate the expectations of potential customers. Regardless of the business model, the management level must develop a clear understanding of customer needs. This is the only way to align the entire organization with the goal of customer orientation and ensure consistent quality. Common methods for recording customer requirements include Customer surveys (in person, by telephone, online, via sales staff)

• Evaluation of customer feedback and enquiries
• Market and competition analyses
• Attending trade fairs, conferences and specialist events
• Benchmarking and comparison of key performance indicators
• Analysing turnover and sales figures

The information collected must then be evaluated and prioritized in a structured manner. Ideally, this takes place in a cross-functional team of employees and managers with direct customer contact. Depending on the complexity of the products or services, this process can be very time-consuming and require the involvement of specialised departments. By systematically recording and evaluating the requirements of interested parties, the organization creates the basis for targeted and customer-oriented quality management. The insights gained are incorporated into the design of products, processes and services and thus make a significant contribution to stakeholder satisfaction and the sustainable success of the company.

Clause 5.2: Policy

Summary

Top management defines a quality policy that provides the framework for the organization’s quality objectives and quality management system. The quality policy should officially state the organization’s intentions and orientation concerning quality.

What does that mean in concrete terms?

Die Norm fordert in Kapitel 5.2.1, dass die oberste Leitung eine Qualitaetspolitik festlegen muss, die folgende Kriterien erfuellt:

• It must be appropriate to the purpose and context of the organization and support its strategic direction.
• It must provide a framework for setting quality targets.
• It must contain an obligation to fulfill applicable requirements (e.g. customer requirements, legal requirements).
• It must include a commitment to continuous improvement of the quality management system.

The quality policy should be formulated clearly, comprehensibly and appropriately for the organization. It serves as a guideline and orientation for the alignment of the quality management system. clause 5.2.2 also requires that the quality policy:

• The following information must be documented and available
• Must be communicated, understood and applied within the organization
• Must be made available to relevant interested parties as appropriate

Top management must actively communicate the quality policy and set an example through their actions.

How can this be implemented in practice?

Die Qualitaetspolitik muss als dokumentierte Information vorliegen und im gesamten Unternehmen bekannt gemacht werden. It is important that the wording is understandable and comprehensible for all employees. The following measures can be taken: The quality policy should be written in clear and simple language, free of unnecessary technical terms. It must communicate the organization’s quality philosophy and orientation to employees. Another important point is that the quality policy must fit the overall strategy and vision of the company . Quality objectives can only be pursued credibly and consistently if they are in line with the company’s objectives. For this reason, top management should always keep the strategic direction in mind when formulating the quality policy and resolving potential conflicts of objectives. Communicate the quality policy via various channels such as notice boards, intranet, employee magazines, meetings or training courses. This way you can reach all employees. Explain and explain the quality policy in staff meetings or team meetings. Top management should exemplify the importance and objectives of the policy and be available to answer questions of understanding. Incorporate quality policy into employee onboardings and training so that new colleagues know and internalize it from the start. Create short versions or visual presentations of the quality policy, e.g. as a poster or video, to make it more descriptive. Carry out regular training on the quality policy to ensure that all employees understand it and act accordingly. Link the quality policy with employee target agreements so that every employee recognizes their contribution to implementation. Publicizing it is crucial to ensure that the quality policy is lived in the company and does not just exist on paper. A wide range of communication measures and explanations make it tangible and understandable for all employees.

Clause 5.3: Roles, responsibilities and authorities in the organization

 

Summary

This clause aims to ensure that it is clearly defined and communicated throughout the organization who has which tasks and responsibilities within the quality management system. A QM system can only function smoothly and effectively if roles, responsibilities and decision-making powers are clearly defined.

What does that mean in concrete terms?

The standard requires top management to ensure that responsibilities and authorizations for relevant roles in the QM system are assigned and communicated. These include, for example:

• Responsibility for ensuring the conformity of the QM system with the requirements of ISO 9001
• Responsibility for ensuring that the processes achieve the intended results
• Reporting on the performance of the QM system and opportunities for improvement
• Die Foerderung der Kundenorientierung in der gesamten Organization
• Maintaining the integrity of the QM system in the event of changes
• These responsibilities and authorities must not only be defined but also made known and understood within the organization. This is the only way to ensure that every employee knows and fulfills their role in quality management.

How can this be implemented in practice?

The clear allocation of roles, responsibilities and authorizations is the key to smooth interaction between all those involved in the quality management system. The following measures have proven successful in practice: Creation of a clear organizational chartAn organizational chart visualizes the organizational structure and makes superordinate, subordinate and subordinate relationships visible at a glance. It should reflect the main functions and areas of responsibility. Writing detailed job descriptions Job descriptions define the specific tasks, competencies, responsibilities and powers for each role. They create clarity and serve as a basis for employee appraisals. Appointment of process owners For each defined core process of the QM system, a process owner or person responsible should be appointed. This function can be assumed by managers or experienced employees. Creation of a responsibility matrix In a matrix overview, tasks, processes and decision-making rights are assigned to the respective responsible roles. This makes it easy to recognize duplicate responsibilities and gaps. Documentation in process descriptions In the descriptions of the individual QM processes, the responsible persons as well as their tasks and powers for this process should be clearly defined. Regulation of representations Mandatory substitution arrangements should be established for critical functions and key positions in order to ensure continuity in the event of absences. Communication and training The defined roles, responsibilities and powers must be made known to all employees and trained if necessary, e.g. in the context of onboardings, meetings or via the intranet. Periodic review and adjustment The assignments of roles and responsibilities should be reviewed at regular intervals to ensure that they are up-to-date and appropriate, and quickly adjusted in the event of changes. Clear structures, binding regulations and open communication allocate roles in the QM system transparent and comprehensible for everyone involved. In this way, frictional losses can be avoided and processes can be implemented efficiently and in a target-orientated manner.

Result

So let’s summarise once again: A concise quality policy exemplified by the management is the foundation and framework for an effective quality management system in accordance with ISO 9001. It sets the long-term direction and creates clarity about the quality objectives. If the quality policy is known within the company and is supported by all employees, it forms the basis for an active quality culture that has a positive effect on customer satisfaction, product quality and employee motivation. It is therefore worth devoting the necessary attention to the formulation and implementation of the quality policy.

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