What is a controlled document in ISO 9001?

If your organisation is pursuing ISO 9001 certification, you’ll likely come across the term “controlled document.” But what exactly is a controlled document in ISO 9001?

What is a controlled document?

Simply put, a controlled document in ISO 9001:2015 is a document that is subject to certain controls to ensure its accuracy and completeness. To be considered a controlled document, it must meet certain criteria, such as being approved by a designated authority and having a defined review and update schedule.

What types of documents are in a QMS?

There are two main types of QMS documented information: management and operational documents.

• Management documents are typically high-level documents that provide an overview of your QMS. These could include your quality policy, objectives, and scope.
• Operational documents, on the other hand, provide more detailed information on how your QMS is implemented. These could include procedures, work instructions, and records.

Do all documents need to be controlled?

It’s important to note that not all documents need to be controlled. That’s right; the decision of which documents to control should be based on the document’s importance to the quality management system and the potential impact of changes to the document. So, for example, meeting minutes that are not critical to the operation of the quality management system may not need to be a controlled document.

Examples of documents that should be controlled include:

• Quality policy and quality objectives.
• Standard operating procedures (SOPs).
• Work instructions and process maps.
• Approved forms and templates.
• Training manuals and competency records.
• Audit reports and corrective action plans.
• Design specifications and test reports.
• Supplier evaluation and approval records.

Examples of documents that may not need to be controlled include:

• Internal meeting notes or brainstorming records.
• Draft documents or working copies not yet approved.
• Informal emails and internal memos.
• Reference materials such as brochures or catalogues.
• Temporary checklists or notes used for short-term tasks.

Controlled documents are typically those that guide or affect quality processes and compliance, while uncontrolled documents are those used for general communication or temporary reference.

Benefits of document control

Establishing an ISO 9001 document management system is required for organisations to ensure the control of relevant documents and records, helping in ensuring compliance with the ISO 9001 standard. ISO 9001 Document Control provides numerous benefits to organisations such as:

Increased accuracy

One of the most important benefits of Document Control for a Quality Management System (QMS) is increased accuracy. In a world where incorrect information can spread like wildfire, it’s crucial to have systems and processes in place to ensure that the documents used by your organisation are accurate. QMS Document control helps create a centralised repository for all organisational documents, making it easier to track and update documents as needed including the identification and removal of obsolete documents. It also helps ensure that only authorised personnel have access to documents, reducing the risk of accidental changes or unauthorised alterations.

Improved communication

Document control also helps ensure that everyone in the organisation is using the same up-to-date information. This reduces misunderstandings and makes communication more efficient.

Reduced costs

By having a central repository for all organisational documents, you can eliminate the need for duplicate copies. This can save money on printing and storage costs.

Improved regulatory compliance

A well-managed document control system can help your organisation meet the international standard ISO 9001 requirements and other regulatory standards.

Enhanced customer satisfaction

When your organisation is able to provide accurate and up-to-date information to customers, they will be more satisfied with your products and services.

Better project management

Having all project information centrally located makes it easier to track progress and ensure that deadlines are met.

What other benefits can document control provide?

Additional benefits of document control include:

• Minimising the risk of data loss.
• Faster product development.
• Providing an audit trail for documents (useful for tracing errors or discrepancies).
• Promoting collaboration and coordination among team members by providing a central repository for all project-related information.

Document control is vital for success

Document control is a cornerstone of an effective Quality Management System (QMS) and plays a vital role in ensuring compliance with ISO 9001:2015 standards. By focusing efforts on maintaining the accuracy, consistency, and accessibility of critical documents you’ll enhance operational efficiency but also improve communication, reduce costs, and ensure compliance with the ISO 9001 standard.