In writing the policy statements and documented procedure for Document Control section of your quality manual, you must be able to properly interpret the requirements of sub-clause 4.2.3 Control of Documents. The following discussion intends to provide basic understanding and it hopes to provide you necessary information in writing your policies and procedures. As stated in the ISO 9001:2008 standard, a documented procedure shall be established to define the controls needed:
a) to approve documents for adequacy prior to issue,
Approval of documents comes without first defining the responsibilities for preparation, review and approval of documents. Defined responsibilities and accountabilities will ensure that documents are really adequate prior to issue. Below is an example of responsibility matrix for a government institution.
b) to review and update as necessary and re-approve documents,
Controlled documents that make up the QMS are many times being called “living documents”. As such, documents must be reviewed for continuing suitability to meet changes in customer requirements, regulations or even internal needs of the organization. To ensure that this will be done, it is recommended that management reviews include action plan for cross-functional review of documents to be facilitated by the MR.
c) to ensure that changes and the current revision status of documents are identified,
This is practically identifying the changes made in the documents. Common approach is to underline the changes or put a small triangle with a revision # inside which is common for engineering drawings. Revision history page may also be used to provide information on description of changes.
d) to ensure that relevant versions of applicable documents are available at points of use,
This is where document distribution comes in. Distribution of print documents is quite tedious to do but still necessary for effective communication of QMS requirements as in the case of manufacturing industries where customer product and process specifications are crucial. However, distribution of electronic documents through the company’s intranet is the emerging approach and this would definitely do well.
e) to ensure that documents remain legible and readily identifiable,
One of the purposes of having documents is to communicate intent and to have legible documents is just rationale. Identification of documents would require you to use some coding system and appropriate document title.
f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled,
The requirements being discussed so far are just for internally-generated documents. But just like any other organization, documents from external entities such as drawings from customers, IRRs and circulars from regulatory agencies are likewise being required to be controlled in terms of distribution, identification and disposition of obsolete versions. For some instances where the latest versions of guidelines and circulars of government institutions are posted in their website, the organization may just have to reference in document control policy the websites URLs to address requirement for distribution and identification.
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
As practiced, obsolete documents are being retained to preserve knowledge, technologies, etc. for possible future research and other purposes. Common approach to identify them is to stamp them with “obsolete” to prevent their unintended use and provide storage area for them.
Should you be looking for sample forms for your document control system, you may download this and have your way for effective control of documents. These forms can be used for other management systems such as environmental management system (ISO 14001) and occupational health and safety management system (OHSAS 18001).
