5 Management responsibility
5.1 General recommendations
5.1.1 Introduction
Leadership of senior management, its commitment and involvement are critical in the development and maintenance of effective and efficient quality management system in order to achieve benefits for all stakeholders. They can be achieved by identifying, supporting and enhancing customer satisfaction. To senior management task is to consider measures such as:
- Development of forecasting, policy and strategic goals of the organization purpose;
- Management of the organization by personal example, to gain the confidence of staff;
- Bring to the staff direction of the organization, values related to quality and quality management system;
- Participation in projects to improve the search for new techniques, solutions and new product development;
- Obtaining feedback directly on the effectiveness and efficiency of quality management system;
- Definition of product, value-added in the interests of the organization;
- Define support processes that influence the effectiveness and efficiency of product;
- Creating an environment conducive to the integration and development of employees;
- Providing an organizational structure and resources needed to support the strategic plans of the organization.
Top management should also identify methods for measuring the activity of the organization to establish the achievement of planned objectives.
These methods include:
- Measurement of financial performance;
- Measurement of indicators of process performance across the organization;
- External measurements, such as comparison with the best achievements and evaluation of a third party;
- Evaluation of customer satisfaction, workers organizations and other stakeholders;
- Evaluation of the perception of consumers and other interested parties the characteristics of the products delivered;
- Measurement of other indicators of success identified by management.
Information obtained from such measurements and evaluations are encouraged to consider as an input to management review to ensure that continuous improvement of the quality management system is the driving force to improve the organization.
5.1.2 Issues to be taken into account
In developing, implementing and managing an organization's quality management system, top management should follow the principles of quality management as set out in Section 4.3.
Based on these principles, top management must acknowledge the leadership and commitment to the following activities:
- Understanding of current and future needs and expectations of customers, complementing the claim;
- Clarification of policy objectives and to improve the understanding, motivation and involvement of employees of the organization;
- Implementation of continuous improvement as a goal in the processes of the organization;
- Planning the future of the organization and management of change;
- Establishing and communicating to staff the foundations for achieving the satisfaction of interested parties.
In addition to the gradual or ongoing continuous improvement to senior management should also consider projects a breakthrough, leading to a change process as a way to improve an organization. In the course of these changes, management should take steps to provide resources and information necessary to maintain the functions of quality management system.
Top management should define the product realization processes, since they directly depend on the success of the organization. Top management should also identify those support processes that affect either the effectiveness and efficiency of life cycle processes, or to the demands and expectations of stakeholders.
Leadership must ensure that processes operate as an effective and efficient system. It should analyze and optimize the interaction of these processes by considering how the product realization processes and support processes.
Attention is drawn to:
- Design consistent and interacting processes to effectively achieve the desired results;
- Clear definition of inputs and management processes, their implementation and outputs;
- Monitoring of inputs and outputs to verify that the individual processes are linked and executed efficiently and effectively;
- Identification and risk management, and use of opportunities to improve performance;
- Analysis of data to facilitate continuous improvement processes;
- Determination of the leaders of the processes and giving them full responsibility and authority;
- Management of each process to achieve the objectives of this process;
- The needs and expectations of stakeholders.
ISO 9001:2000. Quality management system. Requirements 5 Management responsibility 5.1 Management commitment Senior management should ensure that evidence of a commitment to develop and implement a quality management system and continually improve its effectiveness by: |
5.2 Needs and expectations of stakeholders
5.2.1 General Provisions
Every organization has an interest in its activities by, each of which has its own needs and expectations. Stakeholders organizations include:
- Consumers and end users;
- Employees of the organization;
- The owners / investors (such as shareholders, individuals or groups, including the public sector, with particular interest in the organization);
- Suppliers and partners;
- A society in the form of various associations and government agencies for which the organization or its products have an impact.
5.2.2 Needs and expectations
Success depends on understanding and meeting the current and future needs and expectations of current and potential customers and end users, as well as on understanding and addressing the needs and expectations of other stakeholders.
In order to understand and meet the needs and expectations of stakeholders to the organization:
- Identify their stakeholders and the ability to maintain a balanced answer to their needs and expectations;
- To translate the specific needs and expectations into requirements;
- To bring the requirements to all staff of the organization;
- Focus on improving processes to ensure value for stakeholders.
To meet the needs and expectations of customers and end-user management of the organization must:
- Understand the needs and expectations of its customers, including potential customers;
- To establish the basic characteristics of the products for its customers and end users;
- Identify and assess the competitive situation in the market;
- Identify market opportunities, weaknesses and future competitive advantage.
Examples of needs and expectations of customers and end users from the organization's products:
- Compliance requirements;
- Reliability;
- Availability;
- Delivery;
- Activities after the completion of the product life cycle;
- The price and life cycle costs;
- Product safety
- Product liability;
- The impact on the environment.
The organization should identify the needs and expectations of its employees in the recognition, job satisfaction, as well as in their development. Such attention helps to ensure the fullest participation and the most highly motivated employees.
The organization should identify financial and other results that meet the identified needs and expectations of owners and investors.
Management should consider the potential benefits to the organization by establishing partnerships with suppliers to create value for both parties. The partnership should be based on a joint strategy, knowledge sharing, as well as the distribution of income and losses.
In establishing the partnership, the organization should:
- Identify key suppliers and other organizations as potential partners;
- Jointly establish a clear understanding of customer needs and expectations;
- Jointly establish a clear understanding of the needs and expectations of the partners;
- Set goals, providing the possibility of a permanent partnership.
In considering its relationship with society organizations, should:
- To demonstrate their responsibility for health and safety;
- Consider the impact on the environment, including conservation of energy and natural resources;
- To identify the applicable statutory and regulatory requirements;
- Identify current and potential impact of their products, processes and activities on society and the local community in particular.
ISO 9001:2000. Quality management system. Requirements 5.2 Customer Focus Senior management should ensure that customer requirements have been defined and implemented to improve customer satisfaction. |
5.2.3 Legislative and regulatory requirements
Management should ensure that knowledge of the organization of legislative and regulatory requirements that apply to its products, processes and activities and to include these requirements in a quality management system. It should also pay attention to:
- Clarification of compliance with current and future requirements in terms of ethics, efficiency and effectiveness;
- The benefits to stakeholders of increasing compliance requirements;
- The organization's role in protecting the interests of the community.
5.3 Quality Policy
Top management should use the quality policy as a means of managing the organization to improve its operations.
The policy of the organization's quality must be equitable and consistent part of the overall policy and strategy.
In developing a quality policy to senior management should consider:
- The level and type of future improvements necessary for the success of the organization;
- The expected or desired degree of customer satisfaction;
- Development of workers' organizations;
- The needs and expectations of other stakeholders;
- The resources necessary to go beyond the requirements of ISO 9001 ;
- The potential contribution of suppliers and partners.
The quality policy can be used to improve if it:
- Is in line with the forecast and strategy of top management on the prospects of the organization;
- Allows you to understand and pursue quality objectives throughout the organization;
- Reaffirms the commitment of top management commitment to quality and provide adequate resources to achieve goals;
- Helps to explain this commitment to quality throughout the organization with clear leadership of senior management;
- Includes constant improvement related to the needs and expectations of customers and other stakeholders;
- Effectively formulated and skillfully brought to the attention of all staff.
As with other types of policies relating to the business, the quality policy should be reviewed periodically.
ISO 9001:2000. Quality management system. Requirements 5.3 Quality Policy Senior management should ensure that the quality policy: |
5.4 Planning
5.4.1 Quality Objectives
Strategic planning and quality policy organizations provide the basis for setting goals in terms of quality. Top management should develop these objectives aimed at improving the organization. The objectives should be measured in order to promote efficient and effective analysis conducted by the leadership.
In developing these objectives, management should also consider:
- Actual and future needs of organizations and markets served;
- Conclusions from the management;
- Actual product characteristics and process performance;
- Satisfaction levels of stakeholders;
- The self-evaluation;
- Comparison with the best achievements, the results of the competition, the opportunities for improvement;
- The resources needed to achieve goals.
Quality objectives should be brought to the attention of members of the organization in such a way that gives them the opportunity to participate in achieving them. It should define the responsibility for the deployment of quality objectives. Objectives should be systematically reviewed and revised as necessary.
ISO 9001:2000. Quality management system. Requirements 5.4 Planning 5.4.1 Quality Objectives Senior management should ensure that quality objectives, including those necessary to meet requirements for production, were established in their respective divisions and at appropriate levels in the organization. Quality objectives must be measurable and consistent with the quality policy. |
5.4.2 Quality Planning
Management needs to take responsibility for planning the production quality of the organization. This planning should be directed at identifying the processes required to effectively and efficiently achieve the goals and quality requirements of the organization's strategy.
Basic data for efficient and effective planning are:
- The strategy of the organization;
- Specific goals of the organization;
- The specific needs and expectations of customers and other stakeholders;
- Evaluation of legislative and regulatory requirements;
- Evaluation of data on product performance;
- Evaluation of performance data processes;
- Lessons learned from previous experiences;
- These opportunities for improvement;
- Assessment of the risks involved and the data is downward.
Output quality of planning for the organization determine the product realization and support processes, including:
- Needed to organize the skills and knowledge;
- Responsibility and authority to implement plans to improve processes;
- The necessary resources, such as financial resources and infrastructure;
- A matrix for assessing the achievement of improving the performance of the organization;
- Needs to be improved, including the means and methods;
- Documentation requirements, including records.
Management needs to systematically analyze the output to ensure effectiveness and efficiency of the organization's processes.
ISO 9001:2000. Quality management system. Requirements 5.4.2 Quality management system planning Senior management should ensure that: |
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
Top management should define and then communicate to staff the responsibility and authority to implement and maintain the effective and efficient quality management system.
We must give responsibility and authority to all employees of the organization, enabling them to contribute to the achievement of quality objectives and creating the conditions for their involvement, motivation and their commitment.
ISO 9001:2000. Quality management system. Requirements 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Senior management should ensure that responsibilities and authorities are defined and communicated to the staff of the organization. |
5.5.2 Management representative
Высшему руководству следует назначить представителя руководства и наделить его полномочиями управлять, постоянно контролировать, оценивать и координировать систему менеджмента качества. Такое назначение призвано содействовать результативной и эффективной работе и улучшению системы менеджмента качества. Представитель подотчетен высшему руководству и поддерживает связи с потребителями и другими заинтересованными сторонами по вопросам, касающимся системы менеджмента качества.
ИСО 9001:2000. Системы менеджмента качества. Requirements 5.5.2 Представитель руководства Высшее руководство должно назначить представителя из своего состава, который независимо от других обязанностей должен нести ответственность и иметь полномочия, распространяющиеся на: Note. В ответственность представителя руководства может включаться поддержание связи с внешними сторонами по вопросам, касающимся системы менеджмента качества. |
5.5.3 Внутренний обмен информацией
Руководству организации необходимо определить и внедрить результативный и эффективный процесс обмена информацией по вопросам политики в области качества, требований, целей и их достижения. Обеспечение такой информацией может помочь в улучшении деятельности организации и непосредственно вовлекает ее работников в достижение целей в области качества. Руководству следует активно поощрять обратную связь и получение информации от работников организации как средства их вовлечения.
Обмен информацией может, например, включать:
- информирование, проводимое руководством на рабочих участках;
- групповые брифинги и другие совещания, например, по признанию достижений;
- использование досок объявлений, внутренних газет/журналов;
- аудио-видео- и электронные средства, такие, как электронная почта и web – сайты;
- обзоры, подготовленные работниками, и наглядно представленные предложения.
ИСО 9001:2000. Системы менеджмента качества. Requirements 5.5.3 Внутренний обмен информацией Высшее руководство должно обеспечить, чтобы в организации были разработаны соответствующие процессы обмена информацией, в том числе по вопросам результативности системы менеджмента качества. |
5.6 Анализ со стороны руководства
5.6.1 Общие положения
Высшему руководству необходимо развить проводимый им анализ за пределы верификации результативности и эффективности системы менеджмента качества в процесс, распространяющийся на всю организацию, и который также оценивает эффективность системы. Анализ со стороны руководства следует превратить в трибуну по обмену новыми идеями с открытой дискуссией и оценкой входных данных, стимулированных лидерством высшего руководства.
Для добавления ценности организации по результатам анализа со стороны руководства высшему руководству надо управлять осуществлением процессов жизненного цикла продукции и вспомогательных процессов посредством систематического анализа, основанного на принципах менеджмента качества. Частота анализа устанавливается исходя из потребности организации. Входные данные к процессу анализа необходимо преобразовать в выходные данные, охватывающие не только результативность и эффективность системы менеджмента качества. Результаты анализа предоставляют данные, которые используются при планировании улучшения деятельности организации.
ИСО 9001:2000. Системы менеджмента качества. Requirements 5.6 Анализ со стороны руководства 5.6.1 Общие положения Высшее руководство должно анализировать через запланированные интервалы систему менеджмента качества организации с целью обеспечения ее постоянной пригодности, адекватности и результативности. В анализ следует включить оценку возможностей улучшения и потребности в изменениях в системе менеджмента качества организации, в том числе в политике и целях в области качества. |
5.6.2 Входные данные анализа
Входные данные к оценке результативности и эффективности системы менеджмента качества учитывают интересы потребителей и других заинтересованных сторон и содержат:
- статус и результаты достижения целей в области качества и деятельности по улучшению;
- статус пунктов, по которым требовались действия на основе анализа со стороны руководства;
- результаты аудитов (проверок) и самооценки организации;
- обратную связь об удовлетворенности заинтересованных сторон, возможно, даже до момента их участия;
- факторы, связанные с рынком, такие, как технологии, исследования и разработки, деятельность конкурентов;
- результаты сравнения с лучшими достижениями;
- сведения о работе поставщиков;
- новые возможности улучшения;
- управление несоответствиями процессов и продукции;
- оценку рынка и стратегию;
- статус деятельности по стратегическому партнерству;
- финансовые результаты деятельности, связанной с качеством;
- другие факторы, которые могут воздействовать на организацию, такие, как финансовые, социальные или экологические условия и соответствующие изменения законов и регламентов.
ИСО 9001:2000. Системы менеджмента качества. Requirements 5.6.2 Входные данные анализа Входные данные для анализа со стороны руководства должны включать информацию по: |
5.6.3 Выходные данные анализа
Если анализ со стороны руководства выходит за пределы верификации системы менеджмента качества, то результаты такого анализа могут использоваться высшим руководством в качестве входов к процессам улучшения. Высшее руководство может применять этот процесс анализа как мощное средство при определении возможностей улучшения деятельности организации. График проведения анализов способствует своевременному обеспечению данными для стратегического планирования в организации. Отобранные выходные данные следует доводить до сведения работников организации, демонстрируя им, как процесс анализа со стороны руководства ведет к постановке новых целей, которые принесут выгоду организации.
Дополнительные выходные данные для повышения эффективности включают, например:
- цели, касающиеся характеристик продукции и показателей процессов;
- цели улучшения деятельности организации;
- оценку пригодности организационной структуры и ресурсов;
- стратегию и инициативы по маркетингу, продукции и удовлетворенности потребителей и других заинтересованных сторон;
- сокращение потерь и планы снижения идентифицированных рисков;
- информацию по стратегическому планированию будущих потребностей организации.
Необходимо иметь достаточно записей для обеспечения прослеживаемости и облегчения оценки самого процесса анализа со стороны руководства, чтобы убедиться в его постоянной эффективности и в добавлении ценности организации.
ИСО 9001:2000. Системы менеджмента качества. Requirements 5.6.3 Выходные данные анализа Выходные данные анализа со стороны руководства должны включать все решения и действия, относящиеся к: |

















