2. The main provisions of quality management systems
2.1 Rationale for quality management systems
Quality management systems can assist organizations in enhancing customer satisfaction.
Consumers require products whose characteristics would satisfy their needs and expectations. This needs and expectations, are generally recorded in the technical specifications for products and are generally considered to customer requirements. Requirements can be installed in a consumer contract or determined by the organization itself. In any case, the acceptability of products in the consumer ultimately sets. Because the needs and expectations are changing, organizations are also under pressure due to competition and technological progress, they must constantly improve its products and its processes.
The systems approach to quality management encourages organizations to analyze customer requirements, define processes, which would produce products acceptable to consumers, as well as to support these processes in a controlled state. The quality management system can be the basis for continuous improvement to increase the likelihood of increasing satisfaction of both consumers and other interested parties. It gives confidence to the organization and to customers in its ability to deliver products that fully comply with the requirements.
2.2 Requirements for quality management systems and product requirements
The family of ISO 9000 makes a distinction between the requirements for quality management systems and product requirements.
Requirements for quality management systems installed in the GOST R ISO 9001 . They are generic and applicable to organizations in all sectors of the industry or the economy, regardless of product category. ISO 9001 does not establish requirements for the product.
Product requirements may be established customers, or organization, anticipation of customer needs or requirements of regulations. Product requirements and in some cases to related processes may include, for example in the technical specifications, product standards, the standards for processes, contractual agreements and regulations.
2.3 The approach to quality management systems
Approach to develop and implement a quality management system consists of several steps, including:
a) Identify the needs and expectations of customers and other stakeholders;
b) development of policies and objectives of the organization's quality;
c) establishment of processes and responsibilities necessary to achieve the quality objectives;
g) To establish and identify required resources and support to achieve their quality goals;
e) development of methods for measuring the effectiveness and efficiency of each process -
e) use these measurements to determine the effectiveness and efficiency of each process;
g) the definition of the means necessary to prevent inconsistencies and eliminate their causes;
i) the development and application process for continuous improvement of the quality management system.
This approach is also used to maintain the improvements and the existing quality management system.
The organization, which takes the above approach creates confidence in the capabilities of their processes and quality of its products, and provides a framework for continuous improvement. This can lead to increased customer satisfaction and other stakeholders and the success of the organization.
Any activity or set of activities that uses resources to transform inputs into outputs, can be viewed as a process.
To operate effectively, organizations must identify and manage numerous interrelated and interacting processes. Often the output from one process directly forms the input to the next. The systematic identification and management processes used by the organization and above all to ensure their interactions can be considered a "process approach".
The purpose of this standard - to encourage the adoption of a process approach to management of the organization.
Figure 1 is based on process approach quality management system, described in a family of ISO 9000. He suggests that interested parties play a significant role in the organization of input data. Monitoring the satisfaction of interested parties requires the evaluation of information relating to the perception of the parties concerned the extent to which their needs and expectations. The model shown in Figure 1, does not show processes at a detailed level.
Symbols:
-> The activity that adds value
······> Flow of information
Figure 1 - Model of the quality management system based on process approach
Note - wording given in parentheses, are not applicable to ISO 9001.
2.5 Policy and quality objectives
Policy and quality objectives are established to guide the organization. They define the desired results and promote the use of organization resources to achieve these results. The quality policy provides a framework for the design and analysis of the quality objectives. Quality objectives should be coordinated with the quality policy and commitment to continuous improvement, and the results should be measurable. The achievement of quality objectives can have a positive impact on product quality, operational efficiency and financial performance and, consequently, to the satisfaction and confidence of stakeholders.
2.6 Role of top management in quality management system
With the leadership and real action top management can create an environment conducive to the full involvement of workers and the efficient operation of the quality management system. The quality management principles can be used by senior management as the basis for its role in:
a) developing and maintaining policies and objectives of the organization's quality;
b) promote the policy and quality objectives throughout the organization to increase awareness, motivation and involvement of staff;
c) providing guidance on the requirements of consumers throughout the organization;
d) ensuring implementation of appropriate processes to meet the requirements of customers and other stakeholders and to achieve the quality objectives;
e) ensuring the development, implementation and maintenance of the effective quality management system to achieve these quality objectives;
e) provision of necessary resources;
g) periodic review of quality management system;
i) making decisions on policy and quality objectives;
k) deciding on measures to improve the quality management system.
2.7 Documentation
2.7.1 The value of documentation
The documentation makes it possible to convey the meaning and consistency. Its use contributes to:
a) achieving compliance with the consumer I improve quality;
b) provision of appropriate training;
c) the repeatability and traceability;
g) ensure that the objective evidence;
d) evaluating the effectiveness and continuing suitability of the quality management system. Development of documentation should not be an end in itself, but must add value.
2.7.2 Types of instruments used in quality management systems
In quality management systems, the following types of documents:
a) documents that provide consistent information on quality management system, designed for both internal and external use, such documents are of the quality manual;
b) documents that describe how the quality management system applied to a specific product, project or contract to such documents include quality plans;
a) documents establishing the requirements, these include documents containing technical requirements;
d) documents that contain recommendations or suggestions, these include guidance documents;
d) Documents containing information on how to consistently perform the actions and processes, such documents may include documented procedures, work instructions and drawings;
e) documents containing objective evidence of activities performed or results achieved to such documents are records.
Each organization determines the extent of the necessary documentation and media. It depends on such factors as the type and size of organization, complexity and interaction of processes, the complexity of products, customer requirements, the relevant regulatory requirements, demonstrated ability of personnel, as well as the depth to which you want to confirm compliance to the quality management system.
2.8 Assessing quality management systems
2.8.1 Assessing quality management system processes
In assessing quality management systems should be asked four basic questions for each process being evaluated:
a) identified and determined whether the appropriate process?
b) allocated to the liability?
c) if implemented and maintained in working order procedure?
d) whether the process is effective in achieving the desired results?
The combined answers to the above questions can determine the results of the evaluation. Assessment of the quality management system can vary in scope and include activities such as auditing (verification) and analysis of the quality management system, as well as self-esteem.
2.8.2 Audit (audit) quality management system
Audits (inspections) are used to determine the degree of compliance to the quality management system. Surveillance audits (inspections) are used to evaluate the effectiveness of quality management system and identify opportunities for improvement.
Audits (inspections) conducted by the first party (the organization itself), or on its behalf, for internal purposes, may serve as a basis for declaring the organization of its compliance.
Audits (inspections) conducted by the other party may be consumers of the organization or by others on behalf of consumers.
Audits (inspections) conducted by a third party, carried out by external independent organizations. Such organizations usually have accreditation, certification is carried out in compliance with such requirements of ISO 9001. ISO 19011 provides guidance on audit (inspection).
2.8.3 Analysis of the Quality Management System
One of the objectives of senior management - conducting regular systematic evaluation of the suitability, adequacy, efficiency and effectiveness of quality management system with regard to the policies and quality objectives. This analysis may include consideration of the need to adapt policy and quality objectives in response to changing needs and expectations of stakeholders. The analysis includes identification of the need for action.
In the analysis of the quality management system, along with other information sources using audit reports (audits).
2.8.4 Self-esteem
Self-assessment of the organization is a comprehensive and systematic analysis of the organization and results in relation to the quality management system or a model of excellence (Quality Award model).
Self-assessment can provide an overview of the organization and degree of development of quality management system. It can also help determine the organization of areas needing improvement, and priorities.
2.9 Continuous improvement
The aim of continuous improvement of the quality management system is to increase the opportunities to increase customer satisfaction and other interested parties. Actions for improvement include:
a) analyze and evaluate the current situation to identify areas for improvement;
b) setting goals for improvement;
c) identification of possible, solutions to achieve the objectives;
d) evaluation and selection decisions;
e) implementation of selected solutions;
e) measurement, verification, analysis and evaluation of the implementation to determine that whether the objectives achieved;
g) design changes.
The results are analyzed in order to establish further opportunities for improvement. Thus, the improvement is a permanent action. Feedback from customers and other stakeholders, audits (inspections) and analysis of the quality management system can also be used to identify opportunities for improvement.
2.10 Role of statistical techniques
The use of statistical techniques can help in the understanding of climate variability and, therefore, can help organizations solve problems and improve the efficiency and effectiveness. These techniques also contribute to a better use of available data to assist in decision making.
Variability can be observed in the progress and results of many activities even in the face of apparent stability. This variability can be seen in the measured characteristics of products and processes. Its presence can be seen at various stages of product life cycle from market research to customer service and disposal.
Statistical methods can help to measure, describe, analyze, interpret and model such variability, even with relatively limited data. Statistical analysis of these data may help to better understand the nature, extent and causes of variability, thus contributing to the solution and even prevent problems that may result from this variability, as well as continuous improvement.
Guidelines for the application of statistical methods in quality management system are given in ISO / TR 10017.
2.11 Quality management systems and other management systems
The quality management system is part of the organization's management system, which aims at achieving results in line with the quality objectives to meet the needs, expectations and requirements of stakeholders. The quality objectives complement other objectives of the organization associated with the development, funding, profitability, environmental, occupational health and safety. Different parts of the organization's management can be integrated with quality management system in a single system
management, using common elements. This can facilitate planning, resource allocation, identification of additional targets and assess the overall effectiveness of the organization. Organization's management system can be evaluated for compliance with the requirements of their own organization. It may also be checked for compliance with ISO 9001 and GOST R ISO 14001 . These audits (inspections) may be conducted separately or jointly.
2.12 Relationship between quality management systems and excellence models approaches of quality management systems are listed in the ISO 9000 family of standards, and model of excellence based on common principles. Both of these approaches:
a) enable the organization to identify its strengths and weaknesses;
b) include provisions for evaluation against generic models;
c) provide the basis for continuous improvement;
d) include ways to external recognition.
The difference between the approaches of quality management systems ISO 9000 family and excellence models lies in their applications. ISO 9000 family standards include requirements for quality management systems and recommendations for performance improvement; evaluation of quality management systems set these requirements. Model of excellence include criteria to conduct a comparative assessment of the organization, and this applies to all activities and all interested parties. Assessment criteria in excellence models provide a basis for comparing the organization of its activities with other organizations.
