4 QUALITY MANAGEMENT SYSTEM

4 QUALITY MANAGEMENT SYSTEM

4.1 Management systems and processes

Successful leadership and management organization requires a systematic and transparent management. To succeed, you must implement and maintain a management system designed to continually improve the effectiveness and efficiency of the organization, taking into account the needs of stakeholders. Management of the organization along with other aspects include quality management.
Top management should create an organization that focuses on the consumer, through:
a) identify the systems and processes that can be clearly understood, subject to management and improved in terms of effectiveness and efficiency;
b) To ensure effective and efficient implementation and management processes, as well as indicators and data to determine the satisfactory organization.
Examples of activities to build a consumer-oriented organizations are:
- Identification and development of processes leading to the improvement of the organization;
- Collection and use of data and process information on an ongoing basis;
- Development in the direction of continuous improvement;
- Use appropriate methods to evaluate process improvement, such as self-assessment and management review.
Examples of self-assessment and continuous improvement processes are in Appendices A and B, respectively.

ISO 9001:2000. Quality management system. Requirements

4 QUALITY MANAGEMENT SYSTEM

4.1 General Requirements

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall:
a) identify the processes needed for quality management systems and their application throughout the organization (1.2);
b) determine the sequence and interaction of these processes;
c) determine criteria and methods needed to ensure both the implementation and control of these processes;
d) ensure the availability of resources and information needed to support these processes and their monitoring;
e) monitor, measure and analyze these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
The organization shall be managed by these processes in accordance with the requirements of this International Standard.
If an organization chooses to outsource to third parties performing any process that affects product conformity with requirements, it should provide for their part in this monitoring process. Its operation must be defined in a quality management system.

Note. Processes needed for quality management systems, which were discussed above should include proper management processes management, provision of resources, product realization and measurement.

4.2 Documentation

Management should define the documentation, including relevant records necessary to develop, implement and maintain the quality management system and support effective and efficient execution of processes.
The nature and extent of documentation to meet the requirements established by the contract, laws and regulations, requirements and expectations of customers and other stakeholders, as well as the organization's needs. Documentation can be in any form or on any media based on the needs of the organization.
In order to provide documentation that meets the needs and expectations of stakeholders, management should consider:
- Contractual requirements of customers and other stakeholders;
- The use of the organization of international, national, regional and branch of industry standards;
- The relevant requirements set by laws and regulations;
- Decisions of the organization;
- Sources of external information concerning the possibilities of the organization;
- Information about the needs and expectations of stakeholders.
Development, use and management of documentation should be weighed against the effectiveness and efficiency of the organization based on criteria such as:
- Functionality (eg processing speed);
- Friendly to the user;
- The need for resources;
- Policies and objectives;
- Current and future requirements relating to management of knowledge;
- Comparison with the best systems documentation;
- Interaction between customers, suppliers and other stakeholders of the organization.
Access to documentation provided by the organization to employees and other interested parties on the basis of the communication policy of the organization.

ISO 9001:2000. Quality management system. Requirements

4.2 Documentation requirements

4.2.1 General

Quality management system documentation shall include:
a) documented statements of policy and objectives for quality;
b) a quality manual;
c) documented procedures required by this International Standard;
d) documents needed by the organization to ensure effective planning, implementation and management processes;
e) records required by this International Standard (see 4.2.4).

Note 1. Where in this International Standard the term "documented procedure" appears, it means that the procedure is established, documented, implemented and maintained in working order.
Note 2. The degree of quality management system documentation of one organization may differ from another depending on:
a) the size of organization and activity;
b) the complexity and interaction processes;
c) the competence of staff.
Note 3. Documentation can be in any form or on any media.

4.2.2 Quality Manual

The organization shall establish and maintain a quality manual that contains:
a) the scope of the quality management system, including details of and justification for any exclusions (1.2);
b) the documented procedures established for the quality management system, or reference to them;
c) a description of interaction processes, quality management system.

4.2.3 Control of documents

Documents required by the quality management system to manage. Records - a special type of document, and shall be controlled according to the requirements specified in 4.2.4.
To determine the necessary management tools must be developed documented procedure, which provides:
a) verification of documents for adequacy prior to issue;
b) Review and update as necessary and re-approve documents;
c) Ensuring the identification of changes and revision status of documents;
d) ensure that relevant versions of documents at points of use;
e) ensure that documents remain legible and readily identifiable;
f) Ensuring that documents of external origin and their distribution controlled;
g) prevent the unintended use of obsolete documents and apply suitable identification documents retained for any purpose.

4.2.4 Control of records

Records shall be established and maintained to provide evidence of compliance and effectiveness of the quality management system. They shall remain legible, readily identifiable and retrievable. We must develop a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

4.3 Use of quality management principles

For the successful management of the organization and its operation must be managed systematically and openly. Recommendations to management organization, proposed in this International Standard is based on eight quality management principles.
These principles have been developed for use by senior management to improve the organization. They are included in the content of this International Standard and are given below:

a) Customer focus

Organizations depend on their customers and therefore should understand current and future needs, meet customer requirements and strive to exceed their expectations.

b) Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in the organization's objectives.

c) Involvement of people

People at all levels are the essence of an organization and their full involvement enables organizations to capitalize on their abilities.

d) Process approach

The desired result is achieved more efficiently when activities and related resources are managed as a process.

e) System approach to management

Identifying, understanding and managing interrelated processes as a system contributes to the efficiency and effectiveness of the organization in achieving its objectives.

f) Continuous improvement

Continual improvement of the organization as a whole should be regarded as a permanent objective.

g) Making decisions based on facts

Effective decisions are based on analysis of data and information.

h) Mutually beneficial supplier relationships

The organization and its suppliers are interdependent and mutually beneficial relationship enhances the ability of both to create value.
Successful use of the organization of eight management principles will result in benefits to interested parties, such as increasing cash flow, creating value and improving stability.


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