ISO 9000 Document Control Procedures
ISO 9000 states that a procedure should be established and documented for the control of documents. This means that the various stages involved in the control of documentation must be identified and recorded. The standard suggests that only a single document is required to define those stages. But it is possible that various types of documents may require different processes and hence a number of documents could be produced to define the required document processes. However, document control is not a complicated process and while there are many different permutations to the various processes they all involve the same basic steps and therefore should be kept to a single document. This may require an important investment in time in order to define the needs, determine where there is commonality and eliminate duplication, but it is time well spent as it will lead to simplification of the processes and an easier to read document. We will call this the umbrella procedure describing how the document control process should operate.
The elements that should be included in the umbrella procedure of a document control procedure are as follows:
- Creation of procedures, who writes them, how they are written, format principles and the use of forms and diagrams etc.
- The naming and numbering principles for the documents that are controlled.
- The version numbering protocols, rules regarding draft documents and documents that are not yet approved.
- Dating standards such as date of creation, date of approval and date of publication.
- Who reviews the documents and what proof is recorded that they have been reviewed.
- Who approves the documents and how the approval of the documents is recorded.
- Who decides how approved documents are distributed and to whom are these documents published or made accessible to.
- What are the limitations to the publications of the documents, how and where are they to be used.
- Rules to prevent unauthorised copying and the labelling required on copies of the document.
- Rules for the printing of the documents such as, who can print them, how that is recorded and what extra words need to be inserted on the printed versions showing that they have been printed.
- Revision of published documents, requests for changes to the published version, who approves the change request, who implements the changes once they have been approved.
- How are changes recorded and highlighted from the previous revision.
- The rules covering the maintenance of the documents, who should review them and at what frequency the review process should take place. What happens to the document if it needs to be updated and also what happens if nothing is required to be done to it.
- The security processes to prevent unauthorised changes to the documents and protect against loss and theft.
- How are the documents to be filed, where and how are the master copies kept, rules on storing authorised copies and on retrieving these copies once they have been replaced by a new version.
- How and where are outdated versions archived and who has access to them.
- What is an obsolete document and what are the rules regarding their retention.
With document control software most of these tasks are already prescribed and automated and may not need to be separately described in your umbrella procedure. In fact the user manual for the document control software system could be part of your umbrella procedure and while the tasks carried out by staff should be defined in your procedures reference is then made to the user manual on how that task is performed. Effective Document Control & Management is one of the most important steps in the process of total quality management in any business.