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ISO 9001 Documentation

The document summarizes key aspects of document control procedures according to ISO 9001. It explains that document control and record control are two of the first mandatory procedures to be established. Records provide objective evidence of activities while documents are more dynamic information sources. The standard requires organizations to implement procedures to control documents and records, including approval, updating, access and retention. Maintaining accurate records is important for demonstrating compliance and traceability.

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416 views2 pages

ISO 9001 Documentation

The document summarizes key aspects of document control procedures according to ISO 9001. It explains that document control and record control are two of the first mandatory procedures to be established. Records provide objective evidence of activities while documents are more dynamic information sources. The standard requires organizations to implement procedures to control documents and records, including approval, updating, access and retention. Maintaining accurate records is important for demonstrating compliance and traceability.

Uploaded by

bernabeu763
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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ISO 9001 documentation

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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