Effective Document Control Part 4

Part 4: Documented Information

Previously the ISO standards attempted to separate documents into categories: those that provided direction (documents) and those that showed results (records). But there are various examples of documented information that both contain results and provide direction. Organizations need to be aware of these, as well as how to implement and maintain them effectively.


               Electronic databases exist for many purposes. Enterprise Resource Planning software (ERP) contains information such as bills of material, costing, capacity, inventories, and customer requirements. This information is then used to provide direction to an organization in terms of purchasing requirements, production schedules, and shipping. These databases may be standalone, or they may connect directly to the plant floor and customers, providing real-time status and control.

               Calibration: Another database typically maintained by an organization is for tracking the status of measuring devices. This both provides a record of what is in use and provides direction about when the devices need to be calibrated.

               Training: Human Resources often maintains a database of employees and job requirements which provides direction in terms of training requirements.

               Any database is only as good as the information it contains. If the database is kept up to date, it will provide effective direction.

Control charts:

               When a process has monitoring and measuring, whether continuously or at set intervals, the data collected can be displayed in a control chart. This may be for quality control purposes, but control charts are also used to ensure that emissions or other environmental releases do not exceed limits.

               A control chart is a record of what has happened, but it also provides direction. When the measurements are outside control limits, or there is a pattern to the measurements that indicates a trend, information from the control chart is used to adjust the process parameters or settings. There may also be a requirement for segregation of product for further testing.

Standards and Requirements:

               There are many sources of information from outside an organization that must be controlled, maintained, and used for direction. Some examples:

               Legal Requirements: An organization is required to have access to documented information about any legal requirements that apply to its operations. These requirements provide direction in terms of processes, procedures, and methods that may be needed to remain in compliance.

               Customer Requirements: Customers may have simple requirements that are documented in a purchase order, or complicated requirements such as those found in engineering drawings, specifications, or supplier manuals.

               Standards: International standards such as the ISO standards provide direction and allow businesses all over the world to have common methods. Regional and national standards organizations exist, as do industry groups. Each organization needs to determine the standards that apply based on their business, industry, and related needs.

Management System:

               One last category of documented information to consider is that required by the management system itself. There are various reports, minutes, forms, and other items that form part of the record of the organization’s performance but also provide direction.

               Audit reports: record the status of a management system, provide direction when there are nonconformities or opportunities for improvement.

               Management minutes: also record the status of a management system, provide direction in terms of actions that are required.

               Corrective actions: record the status of a nonconformity, provide direction by means of an action plan to address root causes.

               Risk analysis: record the status of risks or opportunities facing an organization, provide direction for addressing the situation.