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 (see 1.2);
b) determine the sequence of these processes and their interaction;
c) establish criteria and methods needed to ensure that as the implementation of these processes, and management;
g) ensure the availability of resources and information necessary to implement these processes and their monitoring;
e) monitor, measure and analyze these processes, as well as
e) take the actions necessary to achieve planned results and continual improvement of these processes.
Management of these processes should be the organization in accordance with the requirements of this International Standard.
If an organization chooses to outsource any processes that affect product conformity with requirements, third-party organization, it must ensure that manage such processes. The management of such processes that are performed by outside organizations, must be identified (marked, described, represented, was recorded) within the quality management system.
Note. Processes needed for the above-mentioned quality management system should have (recommended) to include processes for management activities, provision of resources, product realization and measurement.
4.2 Documentation requirements
4.2.1 General
Quality management system documentation shall include:
a) documented statements of quality 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 the effective planning, implementation and management processes, as well as
e) records required by this International Standard (see 4.2.4).
Note 1. When the text of this International Standard the term "documented procedure" appears, it means that the procedure is developed and maintained in working order.
Note 2. The documentation of quality management systems of one organization may differ from another depending on the volume:
a) the size of the organization and activities;
b) the complexity of the processes and their interactions with each other, as well as
c) the competence (skills) of staff.
Note 3. The documentation can be in any form or by any type of media.
4.2.2 Quality Manual
The organization shall establish and maintain a quality manual that contains:
a) A description of the quality management system, including details of and justification for any exclusions (see 1.2);
b) the documented procedures established for the quality management system, or links to them, as well as
c) description of the interaction between the processes of quality management system.
4.2.3 Control of documents
Documents required by the quality management system must be controlled. Records are a special type of document and should be managed in accordance with the requirements of paragraph 4.2.4
There should be a documented procedure established to determine the management action required:
a) to approve documents for adequacy prior to issue;
b) to review, update (if necessary) and re-approve documents;
c) to ensure the identification of changes and current status in the current edition of the documents;
g) to ensure that relevant versions (editions) of applicable documents are in place for their use;
e) to ensure the preservation of documents in a state that allows them to read and easy to identify;
e) to ensure that documents of external origin and control their distribution, as well as
g) to prevent unintended use of obsolete (obsolete) documents and their proper identification when they retained for any purpose.
4.2.4 Control of records
Must be identified, records be maintained to provide evidence of conformity to requirements and effective operation of quality management system. Records must be kept in a state that allows them to read, easy to identify and find. There should be a documented procedure established to determine the management action required for the identification, storage, security, location, setting retention and removal (elimination) of records.
