What Is a Controlled Document Per ISO?

ISO standards often require strict document controls.

ISO, the International Organization for Standardization, maintains strict guidelines for the control of documents pertaining to business operations. Any company attempting ISO certifications must demonstrate a verifiable method for using, updating, and storing documents pertaining to configuration control of the business.

Controlled Documents

Any document used in the application of any ISO standard must be controlled by means of a quality management system (QMS) specific to the company. ISO defines a controlled document as one that meets these criteria, regardless of the standard applied.

Quality Management

A controlled document may be stored electronically, on a disk, on paper, or as a photograph. The QMS ensures each document's integrity by adhering to specific rules for document use and storage. The extent of individual companies' QMS will vary depending on company size, personnel competency, and complexity of the business.

Structure

Typically, an ISO standard will have four levels of document structure: policy, procedure, work instruction, and forms and records. Each level is designed for a specific area and applied through all levels of the organization. Each type of document can be applied in virtually any business.

References

• ISO: ISO 9001 Documentation Requirements
• 9000 World: Document Control