Getting the Most out of the Document Control Procedure

Getting the Most out of the Document Control Procedure
July 1, 2011 seouser
document quality

To get the most out of the document control procedure, a number of factors need to be taken into consideration. The ISO 9001:2008 quality management standard necessitates the execution of six compulsory procedures, including a procedure for the control of documents, as well as records. To implement these procedures, you will first need to understand the difference between document and record, while also understanding the need to standardise these procedures.

Defining Documents

ISO 9000:2005 Fundamentals and Vocabulary states that a document is information. This could include specifications or procedures, either paper-based or electronic. Documents change and naturally evolve as new data replaces current data, and document control manages this ability to change and the way that it is distributed. In any organisation, information is a huge asset. Procedures need to state how the following requirements will be implemented:

  • How documents are approved for suitability prior to use
  • How documents are reviewed and updated
  • How to identify the correct versions of documents
  • How the correct versions of documents will be accessed
  • How legibility is ensured
  • How external documents are controlled and distributed
  • How to prevent unintended use

Defining Records

A record is different to a document as it is static. A record’s main purpose is to store historical information that will not be changed. Records capture results of tasks performed in a quality management system, such as product realisation process outputs, measurement analysis and improvement systems. As such, records are a primary source of evidence, proving that activities were performed as per requirements. The record control procedure must be designed to identify the follow:

  • Identify and access records
  • How records are stored and for how long
  • How records are protected in order to remain legible
  • How records are retrieved for use
  • How records should be disposed of

The Document Control Procedure and the Certification Process

Now that the difference between records and documents is clear, the next step is to understand the procedure and its importance within the ISO 9001 certification process. In order to understand the procedure fully, and realise the relationship and need for a document control system, certification body audit should be considered. As the final step in the ISO 9001 certification process, auditing plays a crucial role. Records and documents are audited, and companies who have preserved documents and records should have taken the correct steps for certification, which includes audits. For organisations striving for ISO 9001 certification, it is vital that the document control procedure ensures that all documents and records are compliant with Clause 4.2 – as such, this function should be a basic part of the quality management system.