QA-Z Consulting Specialists has explained the Requirements for Document Control clause of ISO 9001:2000.
Quality system standards are universal in their insistence on close and effective control of documentation throughout the Quality Management System, both internal and external documentation.
If documentation is essential to the system then control of that documentation is essential to the implementation and maintenance of the system. The methods established to exert that control must cover the total lifespan of each document.
For example, if an organisation installs fire extinguishers, then documents such as the actual templates of forms used to ensure that testing is undertaken and templates of forms on which customer details get recorded, etc must be controlled as per the Control of Documents clause.
When the form is completed with details of the testing, it becomes a record. The form will then be protected and controlled as per the Control of Records clause. This effectively covers the entire lifespan of the document.
Methods of control vary from organisation to organisation and industry. Control is a specific and unique application not determined within the Standard.
The Standard provides a list of things to implement in order to establish documentation control but does not specify how an organisation is to apply it. This leaves the application to be established as suits the need of the organisation.
Some organisations save processing time through the investment of a documentation control system, which eliminates specific form design, etc.
For example, customer details are entered into the electronic management system and at the click of a button the system sorts the information to produce a quotation or other records. The information that is entered into the system automatically searches for specific details of product prices and suppliers then formulates a quote.
Which documents should be controlled?
Documents as specified in the Standard ISO 9001 only refer to those that impact directly upon the processes in the scope of certification. E.g. (Manufacturing) - Machine Operating Instructions (if these are written incorrectly wrongly, it could affect how the machine operates that produces the product). (Service industry)- Templates of forms that record the customer’s order or expectation (If these forms do not include space for the name of the customer or quantity, type or colour, or specific requests, then how can customer requirements be met?)
One part of the Clause 4.2.3 refers to ‘approval for adequacy prior to issue’ being required of documents. The importance of having this control in place becomes evident in the previously given example. These controls are to safeguard both the organisation and the customer in order to effectively meet customer requirements.