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ISO 9001:2000 - CONTROL OF DOCUMENTS

GENERAL

A process is " set of interrelated activities or interacting activities which transforms inputs into outputs "(ISO 9000:2005).

can be represented graphically as follows:

All processes have an object or purpose, a "something" that seek to achieve and that is given by the area and management of its own. ----------------------------------------------

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Documents required by the QMS must be controlled. Records are a special type of document
be controlled according to the requirements given in 4.2.4.
should be a documented procedure to define the controls needed to
a) approve documents for adequacy prior to issue,
b) review and update documents as necessary and re-approve,
c) ensure that identify changes and current revision status of documents,
d) ensure that relevant versions of applicable documents are available at point of use,
e) ensure that documents remain legible and readily identifiable,
f) ensure that identifies the external documents and their distribution controlled, and
g) prevent the unintended use of obsolete documents and apply suitable identification if they are retained for any reason.

4.2.3 Control of documents, ISO 9001:2000

DEFINITIONS

Document information and its environment EXAMPLE

support registry specification, documented procedure, plan, report, statement.
NOTE 1 The medium can be paper, magnetic disk, optical or electronic, photograph or master sample, or a combination thereof. NOTE 2
often a set of documents, for example specifications and records, called "documentation."
NOTE 3 Some requirements (eg, the requirement to be readable) relate to all types of documents, but may have different requirements for specifications (for example, the requirement to be revision controlled) and records (eg The requirement to be recoverable).

REQUIREMENT ANALYSIS - PROCESS CONTROL OF DOCUMENTS

OBJECT

Identifying, controlling and making available all documents relevant to the operation of the QMS, this consideration is extended to the relevant documents of external origin.

DATA ENTRY

include details of the documentation and information systems that an organization uses to support its QMS. This consideration also applies to external documents:

- documents that require control, how are, how often change, who owns
- the type or class of such documents, for example, plans, designs, formats, electronic media, audio, posters, etc
- identifying documentation needs
- identification of various control options, for example, software, ringtones, databases, file systems and library. ACTIVITIES

should establish a (I) procedures (s) documented (s) to define the controls needed to meet the requirements of clause 4.2.3 of ISO 9001:2000. This procedure should clearly define the areas where they apply (use) the different documents, and the various responsibilities associated with the generation, review, monitoring and maintaining them. The documentation must be available and accessible when required.

OUTPUTS

include:

- a (I) document (s) of procedure including the responsibilities and authorities

- registration document or similar index, to enable identification of changes or revisions to state

- distribution of documents or storage systems, for example, in paper or electronic media, intranet, internet, etc.

- records system files

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