4.2.3 Control of documents

The intent of this element is to ensure that people use the correct versions of the correct documents. The use of incorrect or obsolete documents can result in mistakes and, ultimately, in nonconforming product (product includes service). New or revised documents should be approved prior to issue. This does not necessarily mean that documents needed to be signed. Any form of approval is acceptable as long as the procedure indicates what constitutes the evidence that the document is approved. Once documents are approved, the new revised documents need to be available at the locations where they are used or needed. Obsolete documents need to be removed and destroyed. If obsolete documents are not destroyed, they should be identified so that people know they are not supposed to be used.

In order to control the use of documents, ISO 9001 requires a method for identifying the current revision status of documents. One way this can be done by maintaining a master list that identifies all controlled documents and their revision status (number, date or equivalent). Any controlled document can be compared with this master list to verify if the latest revision is in use. Another possible method that precludes the use of obsolete documents is the use of a master file of original documents (such as drawings).

Of all requirements of ISO 9001, this is one that is most likely to be over applied. It is important not to loose sight of the intent of this requirement: to control the distribution of documents to make sure that work is being carried out according to the correct set of instructions. Document control is basically about making sure that the document that is in use is the applicable approved issue. This is important because people must have the information they need to do the jobs.

There is a risk of ending up with complex arrangements for updating and retrieving documents. The standard requires information to be up-to-date, but does not specify how this should be done. There is a lot of flexibility. By adopting the simplest and most practical methods of document control, unnecessary bureaucracy and costs can be avoided.
Organizations need to have a documented procedure for control of documents.

The documented procedure is required for:

• approve documents for adequacy prior to issue
• review, update and re-approve
• identifying changes and current revision status
• making document (current version) available at all points of use
• document to remain legible and readily identifiable
• to have control on external origin documents. 2008 edition requires controlling all external origin documents which affects planning and operation of QMS.
• prevent unintended use of obsolete document i.e. preventing use of old version of the document. Identifying old documents, if retained.

Requirement on control of external origin documents revised to "ensure that documents of external origin determined by organization to be necessary for planning and operation of quality management system". Now organizations will need to control all external origin documents as term "necessary for planning and operation of quality management system" has no boundary.

Earlier in absence of the clarity many organizations have taken only those external origin documents under control which affected product quality or product requirement.

Following additional documents may also be required to take in control (examples):

• Excise, Value added tax etc, procedures and laws affects delivery of product, which is a product requirement or customer requirement, as covered in 7.2.1, and hence needs to taken in document control.
• Vendor approval procedures of the customer as it may affects quantity of various products ordered by customer, i.e. planning and operation of QMS.
• Laws related to disposal of scraps, waste etc.

Over and above all, documents should be legible, meaning the user should be able to understand the contents. If you are giving a document written in English to a person who do not understand English then it will be treated as nonconformity. So you need to prepare documents such that its user is able to use it. You can prepare pictorial instructions which eliminates language barrier and you can prepare instruction in a language understood by intended user.

External Document Reference: Documentation Kit

Procedure for Control of Documents

Control of External Origin Documents for Use

Distribution List

Document Approval and Revision Control Register

Document Amendment Note

Document Issue record