What is Document Control?

Document Control Definition

Document control can refer to a document management profession or a practice for managing product and quality related documentation. In some industries, like medical device manufacturing, there are regulatory compliance requirements specifying the practices for creating, managing, distributing, and disposing of documents. Product companies should identify the best practices to protect proprietary or sensitive documentation.

What is a Document Control


Why is document control needed?

Document control is an essential element of an organization’s quality management system (QMS). It ensures that only approved and up-to-date documentation is used throughout an organization. Regulated companies are subject to document control requirements set forth by ISO 9001.

*Source: thecoresolution.com

When should a document be controlled?

A document should be controlled if it meets any of the following criteria:

  • Guides the production of a product
  • Guides the verification, inspection, or testing of a product
  • Defines customer and/or product requirements
  • Used for defining or controlling processes
  • Used for decision making by production personnel
  • Used for data collection
  • Used for training personnel
  • Addresses or relates to an ISO 9001 requirement

*Source: aqmauditing.com

Why is document control an essential department within manufacturing companies?

Document control is essential to manufacturing companies because it ensures efficiency, performance, reliability, traceability, and quality throughout the entire product lifecycle.

*Source: consepsys.com

What is document control requirements?

Document control requires the following:

  • Review and approval of documents for adequacy prior to release
  • Review/update/re-approval of documents on an as-needed basis
  • Identification of changes and current document revision status
  • Ensuring that relevant versions of applicable documents are available at points of use
  • Ensuring that documents remain legible and readily identifiable
  • Identification and controlled distribution of external documents
  • Preventing obsolete documents from unintended use
  • Policy or procedure for the identification, storage, protection, retrieval, retention, and disposal of documents

*Source: the9000store.com

The Cost

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