Iso 9000 document

The document control procedure (4.2.3) and record control procedure (4.2.4) are usually
the first of the six mandatory procedures to be initiated when implementing an ISO
9001:2008 quality management system.

A robust document control process invariably lies at the heart of any compliant quality
management system because almost every aspect of auditing and compliance verification
is determined through the scrutiny of documented evidence. With this in mind, it
becomes apparent that the ongoing maintenance of an efficient document management
system must not be overlooked.

Difference between Documents and Records

What does ISO 9000:2005 tell us about the difference between documents and records
and furthermore; why it should matter?

The standard tells us that documents are considered as being information (e.g.
specifications or procedures) and its supporting medium (e.g. paper or electronic). The
standard implies that over time these documents will evolve as new information
supersedes old and that change must be managed. Documents are active and dynamic.

Records, on the other hand, are more static since they are historical in nature. They are
the documents that state the results of activities undertaken in accordance with the
product realization, measurement, analysis and improvement processes (e.g. calibration
logs and non-conformance or corrective action reports). They also provide evidence that
an activity was performed in the manner specified (e.g. inspection records).

Requirements for Controlling Documents and Records

What does ISO 9001:2008 tell us about ensuring compliance with the principal
requirements of document control procedures?

Clause 4.2.3 tells us that an organization must control the documentation required by the
quality management system and that a suitable document control procedure must be
implemented to define the controls needed to; approve, review, update, identify changes,
identify revision status and provide access. The document control procedure must clearly
define the scope, purpose, method and responsibilities required to implement these
parameters.

ISO 9001:2008 does not define how an organization should format its documentation,
since most organizations maintain a consistent corporate image, it is expected that any
corporate format will suffice.
Similarly; Clause 4.2.4 demands that an organisation must implement a documented
procedure to define the controls needed for the identification, storage, protection,
retrieval, retention and disposition of records and that these records must remain legible
and identifiable throughout their retention period.

It is acceptable to combine the control of records procedure with the document control
procedure but care should be taken not to obscure the differences between records and
documents.

What's so important about Records?

Records are an important organizational asset; they provide the primary route for
evidence based verification and traceability, and are able to demonstrate compliance with
customer requirements. Records also prove the efficacy of the quality management
system.

Delivery of such records to a client is often a contractual and legal requirement. In certain
industries, such as civil engineering, assurance records become a fundamental point of
reference when determining compliance with the intended design as well as helping to
satisfy the requirements prescribed by building control authorities and the health and
safety executive. These records are demonstrative of a contractor's duty of care and that
the end product is fit for purpose.

The Document Control Function

The document control function is an administrative management activity and operates on

the frontline by ensuring compliance with Clause 4.2 and the associated document
control procedures and record control procedures. Generally, the document control
function should have a direct report to the Quality Representative.

Summary

Remember; keep it simple and allow the process owners to write or revise the documents
they need. Use the document control function to apply formatting and revision changes as
well as distribution and retention. It is best to interpret the requirements as they apply to
your company; there is no hard and fast method.

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