QMS 9001 Document Control Procedure, QMS 9001 Document Control Procedure Template

QMS 9001 Document Control Procedure

The document control procedure is a systematic approach to creating, managing, and using documents within an organization. It ensures that documents are standardized and controlled, providing a single source of truth for each record. This leads to increased efficiency and reduced risk of error as employees only need to consult one location for the most up-to-date information. In addition, a well-implemented document control procedure can help your organization improve communication, reduce waste, and ensure compliance with regulations.

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QMS 9001 Document Control Procedure

Importance of document control procedure

  • Paper-based documents are converted to electronic counterparts, resulting in lower complex expenses and administrative expenditures: Using less paper, printing, and filing hard copies.
  • Reduced the number of papers that are lost or missing.
  • Documents are stored in a central electronic repository that includes security and hierarchical standards.
  • Search and retrieval capabilities.
  • Documents can be accessed via the internet.
  • Collaboration and version management of documents has improved.

How to implement a document control procedure

There are a few critical steps to implementing an effective document control procedure:

QMS 9001 Document Control Procedure Steps

  • Define your scope:
    The first step is identifying which documents must be included in the procedure. Depending on your industry and organization, this may consist of product specifications, manuals, drawings, and quality records. Once you have identified the types of documents that need to be controlled, you can develop specific controls for each.
  • Create document templates:
    Developing standardized templates for each document type will help ensure consistency and make it easier for employees to find the information they need. Including all relevant information in each template, such as author information, revision history, and approval dates, is essential. Some of them include:
  1. Work instructions.
  2. Technical specifications.
  3. Audit Reports.
  4. Procedure manual.
  5. Implement a change management process.
  • Change Management Process:
    Any changes made to documents must be controlled and tracked so that everyone is aware of the latest version. A change management process should be implemented to ensure that only authorized personnel can make changes and that all changes are documented and recorded.
  • Train your employees and assign responsibilities:
    Train employees on the new procedure and provide ongoing support. Monitor compliance and adjust as necessary to ensure the system is effective. All responsibilities should be assigned as per their respective designation. Actions should be described in detail so that the purpose of the procedure is clearly understood.
  • Record keeping:
    To maintain an accurate history of all the documents and data associated with a project, it is necessary to have a system for recording when documents are created, modified, and destroyed. This information can generate reports on the project's progress and help track any errors or inconsistencies. 
  • Approval:
    The key to getting approval for a document control procedure is to ensure that the benefits are clear and relevant to everyone involved. Make sure the process is easy to understand and navigate and be prepared to answer any questions.
  • Revision:
    This includes creating and implementing a new document management system and revising procedures for reviewing, approving, and issuing documents. The need for this revision arises from the business's constantly changing and expanding nature. With new products and services being developed regularly, it is essential that our documentation accurately reflects these changes.
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QMS 9001 Document Control Procedure Template

Some great ways to maintain documents 

  • Numbering:
    To maintain a proper and consistent documentation process, a Numbering system is required. The system should use a standard format for document numbers, and the numbering scheme should be consistent across all documents. The system should also be designed so that new records can be easily added to the system without disrupting the existing numbering scheme.
  • Access and storage: 
    Even if you don't have a lot of documents, it's still important to keep them organized so that you can find what you need when you need it. One way to do this is to create folders for different types of documents. For example, you might have a folder for customer invoices, another for vendor contracts, and another for employee records. You can also use labeling systems to help you remember where things are.
  • Archiving and retention:
    Proper document archiving and retention can help improve decision-making, optimize business processes, and even protect the company in the event of litigation. Two main approaches can be used for archiving documents: manual and electronic. Manual archiving is the traditional approach, where physical copies of documents are stored in a file cabinet or other storage area.
  • Document review:
    The process of document review is a critical step in most legal cases. The reviewed documents can provide vital clues as to the facts of the case and how to best present those facts in court. As such, the process must be done thoroughly and efficiently.

Documentation requirements for ISO9001

  • Quality policy and objectives: ISO defines the quality policy's requirements, and the quality policy must be a document in and of itself. It also outlines the quality objectives that must be met.
  • Quality manual: A quality manual is a document that outlines the procedures for performing and monitoring quality assurance activities within a business. The quality manual should be tailored to the business's specific needs and designed to ensure that products and services are consistent with high quality. The quality manual should also be easy to use so that all employees can reference it when necessary.
  • Additional records: Additional records may be required to demonstrate ISO compliance with processes, products, and the quality management system. While the control criteria for such records differ from those for other documents, ISO requires that they be controlled.
  • Approving documents for ISO9001: Which files are final and approved, as well as who supported them, are defined by document approval procedures. They keep track of documents, policies, work instructions, handbooks, and other materials that have been accepted. Document acceptance stages in Document Locator are tailored to meet company needs. People are notified of their duties in review, acceptance, and sign-off as documents are routed, and notifications are issued.
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