Document control is important because it’s vital in maintaining the quality of processes and products. It ensures that correct, up-to-date information and procedures are consistently followed. Without effective document control, quality can be compromised due to miscommunication or use of outdated information or procedures. This can lead to inconsistencies, errors, non-compliance with regulations, and other issues that can negatively impact an organization’s performance and reputation.

Document control in QMS is the process that manages documents in a way that ensures they are current, accessible, and effectively controlled. It involves the creation, approval, distribution, and retrieval of documents. It’s a key component of QMS as it ensures the consistency, traceability, and accessibility of documents.

The ISO 9001 requirement of document control stipulates that an organization must establish, implement and maintain a process to manage documents related to its quality management system. This includes procedures for document approval, review, update, and re-approval. Documents must be readily available where they are needed, and obsolete documents must be removed from use. The organization must also ensure that documents from external sources are identified and their distribution controlled.

A document control system improves how information is stored and accessed within an organization. The system should have these key components to improve security while enabling the right people to find the necessary information.

• Document storage: The system can store the relevant documents from many different sources.
• Access control: This feature restricts document access based on job roles, ensuring only authorized personnel can view specific documents. 
• Revision management: Document control software should track revisions so it’s easy to see where users make changes to a document.
• Distribution of documents: The right document control system will have automation built in to help distribute the correct documents as needed.

Numerous benefits come with implementing document control. These include:

• Improved productivity: An organization can improve its document control system efficiency by automating specific workflows.
• Fewer errors: Centralized systems reduce the risk of errors associated with improper version control. 
• Better collaboration: Document control software allows employees to collaborate more effectively on a single centralized document.
• Improved security: A document control system ensures only the people with the right permissions can access sensitive information.
• Regulatory compliance: A document control system helps an organization manage its documentation in line with regulations. This includes policies, procedures, and sensitive employee and industry-related records.
• Consistent quality: An organization can streamline its quality processes with all quality documents in a single system. The result of this is improved products and happier customers.

This shows that document control can touch all areas of an organization to help improve efficiency while ensuring compliance.

A document control system works by managing the lifecycle of documents. It starts with the creation of the document, followed by review and approval from authorized personnel. Once approved, the document is distributed to relevant parties. The system ensures that all versions of the document are controlled, preventing the use of obsolete versions. The system also manages the retrieval, retention, and disposal of documents, ensuring compliance with regulations and standards dependent on the industry.

When an organization implements its document control system, it depends on several factors. One catalyst is growth. If a company is scaling, that added complexity could necessitate formal document control processes. If so, choosing flexible document control software that can scale with the organization’s needs is important.

New or changing regulations can also signal the need for a document control system. Many regulatory standards require specific document procedures and policies. Document control software can benefit businesses by helping them systematically organize documents to stay compliant. On top of this, version control and security features can also help with compliance.

If an organization faces issues such as document errors, security breaches, or inefficiencies with paper-based systems, document control software can help. An organized system can improve the accuracy of documents and reduce the chance of errors, making things easier to find. If a company regularly encounters operational challenges, proper document control can improve visibility and reduce the chance of security issues.

Document control can significantly benefit any industry where quality and compliance are a priority. These include biotech, food and beverage, medical devices, manufacturing, life sciences, and many other sectors. 

For example, a medical device manufacturer might use a document control system to guide inspections and testing while adhering to industry regulations. This strategy helps those on the factory floor follow guidelines for compliance and consistent product quality.

A construction firm, on the other hand, might use document control to manage each project from start to finish. That means creating documentation relating to design and planning and ensuring it reaches the correct stakeholders. As well as keeping everyone in the loop, it also ensures everyone is working from the same version of the construction plans.

Document control involves the systematic process of creating, reviewing, approving, distributing, and ultimately disposing of documents. It highlights the importance of maintaining version control, managing changes, and complying with regulatory standards to ensure document integrity and security.

In contrast, document management refers to organizing, storing, and accessing documents within an organization. Its goal is to enhance efficiency and collaboration by providing a centralized platform for document retrieval and usage.