ISO 9001 Document Control Requirements

In the world of quality management, particularly under the ISO 9001 standard, document control is an essential aspect of ensuring consistency, compliance, and continual improvement. But what exactly does "controlled document" mean, and why is it so important?

A controlled document is any document that is critical to your company’s quality management system (QMS). These documents need to be properly managed to maintain their integrity and relevance within the organisation. Whether it’s a policy, procedure, or work instruction, a controlled document is part of the framework that helps businesses comply with ISO 9001:2015 standards.

What is Document Control?

Document control refers to the processes and procedures that ensure a company's documents are created, reviewed, updated, and archived in a systematic way. This is crucial for maintaining accuracy, accountability, and consistency across the organisation. Document control helps to:

• Ensure that only the most current version of a document is being used
• Prevent obsolete documents from being used
• Track who has approved and reviewed documents
• Ensure that document distribution and access are controlled
• Protect sensitive or confidential information

In short, document control ensures that everyone in the organisation is working from the same, most up-to-date set of guidelines.

What is a Controlled Document in ISO 9001?

In the context of ISO 9001, a controlled document is one that plays a role in meeting the requirements of the QMS. ISO 9001, which is a global standard for quality management, outlines specific requirements for companies to ensure that controlled documents are properly managed throughout their lifecycle.

Controlled documents under ISO 9001 must adhere to the following criteria:

• Identification: Each controlled document must be easily identifiable, including its version, the date it was approved, and its status (i.e., active, obsolete, or under review).
• Review and Approval: Controlled documents must go through a formal review and approval process before they are issued or modified. This ensures that the content is accurate, relevant, and in compliance with the company’s QMS.
• Version Control: To avoid confusion, controlled documents should be numbered and dated. Every time a document is modified, a new version is issued, with the previous version being either archived or removed.
• Access Control: Only authorised personnel should have access to controlled documents to prevent unauthorised edits, deletions, or dissemination.
• Distribution: Once a document is approved and issued, it must be distributed to the relevant departments or employees. Access can be controlled through physical or digital means.
• Archiving and Retention: Obsolete documents should be clearly marked and archived for record-keeping and compliance purposes. The company should also establish retention periods based on legal or regulatory requirements.

Why is Document Control Important for ISO 9001?

The purpose of document control in ISO 9001 is to ensure that an organisation’s quality management processes are clearly defined, consistent, and effective. Without proper control, there’s a risk of using outdated or incorrect documents, leading to mistakes, non-compliance, or a decline in the quality of products or services.

By having a robust document control system, businesses can:

• Ensure compliance with ISO 9001 and other regulatory standards
• Improve the efficiency and accuracy of work processes
• Provide clear guidance for staff, reducing errors and rework
• Facilitate audits by ensuring that the required documents are available and up-to-date
• Safeguard company data and intellectual property

The bottom line

A controlled document in ISO 9001 is an essential element of any quality management system. It ensures that the right documents are being used at the right time, with a consistent approach to approval, distribution, and review. By implementing effective document control processes, organisations can maintain compliance, improve quality, and foster continual improvement.

If you're looking to streamline your document management and ensure compliance with ISO 9001, consider adopting a document management system that integrates document control features—automating version control, approvals, and access management to improve efficiency and reduce human error. Sound good? KeyDocs might be the solution you need. Book a demo now.

‍