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Clause 4 of ISO 9001:2008

October 22nd , 2011

Continuing with the series of blogs on the TouchBase product and ISO 9001 standard, this blog will focus on clause 4 of the standard. The important sections of this clause are the writing of a quality manual and supporting procedures, controlling those documents and records generated while filling in the formats.

Statistics show that the maximum number of non-conformances in the implementation of ISO 9001 is attributable to document control. The reason is that companies keep documents in hard and soft copies and one can find company personnel using obsolete copies of documents which result in non-conformances when audits are carried out. What is useful is to have a document management system with appropriate access rights defined so that all the documentation- quality manual, procedures and formats are controlled. Companies have matured over the years after implementing ISO 9001 and many of them use a version control software to manage their documents.

TouchBase has a document management system module (DMS) which takes care of the version control aspect of storing documents. However, the benefit of using DMS is that one can define workflows for document creation and the approval cycles so that one does not have to search in emails to find approvals to new documents. During audits, one does find people searching for their document approvals and that also leads to non-conformances. In DMS, one can define the document creator and approver as per the document control procedure and all approval records are stored as part of the DMS.

Companies who have implemented ISO 9001 should try the DMS module of TouchBase and life will be much easier for the Management Representative.