ISO 9001:2000 requirements

4. Quality management system

4.1General 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 the quality management system and their application throughout the organization (see 1.2),

The organization shall

b) determine the sequence and interaction of these prThe organization shall

c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,ocesses,

The organization shall

d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,

The organization shall

e) monitor, measure and analyse these processes, and

The organization shall

f) implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes.

Control of such outsourced processes shall be identified within the quality management system.

NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, ande) records required by this International Standard (see 4.2.4).

NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and c) the competence of personnel.

NOTE 3 The documentation can be in any form or type of medium.

4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes
a) the scope 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 reference to them, andc) a description of the interaction between the processes of the quality management system.

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents?
c) to ensure that changes and the current revision status of documents are identified?
d) to ensure that relevant versions of applicable documents are available at points of use?
e) to ensure that documents remain legible and readily identifiable?
f) to ensure that documents of external origin are identified and their distribution controlled?to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

Records shall remain legible, readily identifiable and retrievable.

A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.