ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

4.2.3 Control of Documents - Continued

ISO 9001 Training - Key Explanation Points and Tips:

Not all documents need to be available everywhere within your organization. You must determine what document is applicable (i.e. needed to assure product or process quality) to a specific process or activity and make the relevant version of that document available to that activity, e.g. providing current packaging and shipping work instructions to the shipping department. Your procedure must cover how this is done.

Once you determine that certain documents need to be made available at various locations, implement some form of distribution control. There are many ways to do this. One way would be to keep a distribution log. Your procedure must cover your form of distribution control.

Documents can take a beating in very harsh environments (covered in oil, dust, acid eaten, weather-beaten, etc.) to the point of being illegible. You must regularly review the condition of frequently used hardcopy documents to determine whether they need to be replaced. Your procedure must cover how this is done.

Documents must also be readily identifiable as to its purpose and scope. A simple heading may suffice, (e.g. In-process Inspection Sheet). Computerized documents are sometimes given file names that don’t identify its contents and this might require numerous files to be opened before you find the right one.  Identification also implies effective filing for timely retrieval, whether manual or computerized. A frequent nonconformity is not being able to retrieve a document or record because of poor filing procedures.

External documents (such as customer drawings or supplier material/part specifications) must be identified. There are many ways to do this. One way would be to keep a manual or computer list of these documents. Determine who needs these documents and have some form of distribution control. Your procedure must cover how this is done.
ÞDon’t overlook  supplier, regulatory or industry documents. Apply applicable controls to these as well (4.2.3f).

Obsolete documents can cause many problems if not controlled. There are many ways to do this. One way would be to provide computerized documents in read-only mode and make only the current version accessible at workstation computer screens. Obsolete hardcopy documents can be removed through distribution control.  Your procedure must cover how this or other methods are used.

Ensure your procedure also covers methods to disallow unauthorized and unapprovedor incorrect documents from being created, used or distributed.

If documents are archived, make sure that all such documents are properly identified, indexed and filed, and preferably have controlled or restricted access to them. Again your procedure must cover how this is done.

Nonconformities against the document control process are one of the most frequent audit findings. Develop appropriate performance indicators to demonstrate effective implementation of your document control process. Examples include - number of obsolete or unauthorized documents found being used; number of unauthorized changes found; number of instances documents were not available at points of use; etc. Track trends in these indicators and use this information to tighten your controls and continually improve your document control process.

As mentioned in clause 4.1, use the PDCA to plan, implement, measure and improve your document control process. Your procedure should describe this approach.