ISO 9001:2015 document control is an important component of the ISO 9001 quality management system. It ensures that organizations maintain and manage their documents as the regulatory standard mandates. Organizations must have proper policies, procedures, and regulations focusing on how the users should create, review, approve, and update documents. Using ISO 9001 document control in an ISO document management system, organizations can prevent errors, ensure that the latest versions are in use, and maintain the integrity of the quality management system. Proper document control is essential for compliance, consistency, and continuous improvement, which are core principles of ISO 9001:2015
One of the most important requirements for regulatory compliance is documentation; In fact, a well-designed system to create, update, access,…
ISO 9001:2015 Document Control Requirements
To remain ISO 9001:2015 compliant, organizations must have robust document control. Organizations with a robust document control system can avoid noncompliance penalties, reduce risks, and increase overall efficiency. To remain compliant, businesses across various industries, including manufacturing, healthcare, finance, and service sectors, must follow these six parameters.
Document Identification
Each document must possess a unique identity comprising a title, reference number, revision status, and issue date. These distinctive markers facilitate easy location, reference, and effective ISO 9001 document management across its entire lifecycle.
Document Approval and Review
A documented approval procedure should be established, delineating the responsible parties for document approval and periodic review. This process guarantees the utilization of accurate, current information within the organization.
Document Distribution
All important personnel should have ready access to documents, supported by a transparent ISO 9001 document control software system for distributing and monitoring document revisions. This ensures that employees have access to updated and recent documents.
Document Storage and Archiving
A proper storage system is an important requirement as organizations must have track of all documents. Now that cloud-based systems are required, all documents must be updated on the cloud. This system allows organizations to store, archive, and retrieve data anytime, anywhere.
Document Change Control
A robust change control process with the feature to monitor and communicate document changes to all stakeholders is an important requirement of ISO 9001:2015. This helps manage document revisions and updates.
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Six Mandatory Document Controls in ISO 9001
According to Clause 7.5.3, “Control of Documented Information,” the purpose of a document control procedure is to ensure the availability and suitability as and when needed, and there is adequate protection from loss of confidentiality, improper use, or integrity. However, to follow this clause, knowing the difference between documents and records is important.
A document holds all the information about the company and helps the management to create an effective and efficient organizational operation. On the other hand, a record acts as evidence of a past event. Records are facts and cannot be altered at any point.
While focusing on document control, it is important to know its essential components. ISO 9001:2015 defines six essential components for your ISO 9001:2015 document control procedure:
Document Approval
The first step in ISO 9001 document control is implementing a defined process for approving new documents. This is necessary to ensure consistency and thorough approval by relevant personnel. Organizations must outline the review process while assigning approval rights to the right personnel and maintain a comprehensive audit trail.
Document Updating and Reapproval of Amended Documents
Periodic document review is a key aspect of document control procedure of ISO 9001. This keeps documents current and aligned with organizational practices and regulations. If there are any irregularities, they must be reported and properly amended to keep in line with the regulations and the organization’s goals.
Identify Changes
Document change management is an important component in the ISO 9001 document control process. Organizations must maintain a change audit trail to easily identify document modifications, including the users who made the change and the dates of changes.
Make Documents Available Where Needed
Ensure documents are accessible to those who require them and notify relevant parties of any changes. An ISO document management system can streamline this process and clarify document ownership.
Control Documents of External Origin
Implement ISO 9001:2015 document control to external documents by creating user rights and restrictions. Using a Document Management Solutions helps manage external partner access effectively.
Prevent Inadvertent Use of Obsolete Documents
To prevent accidental use of outdated documents, users can mark them obsolete. However, this is no longer a concern with the rise of cloud-based ISO document management systems. Users must be aware of version control and use a single document instead of creating multiple copies of the same file.
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ISO 9001:2015 Document Control Implementation Steps
ISO 9001:2015 is a globally recognized standard for Quality Management Systems that provides a structured and systematic approach to Quality Assurance. Compliance with ISO 9001:2015 signifies an organization's commitment to delivering high-quality products or services and a dedication to continuous improvement.
Document control within the ISO 9001:2015 framework ensures that critical information is managed effectively. This enhances product and service quality by reducing errors, discrepancies, and inconsistencies. It instills confidence in customers and stakeholders, as they can trust that the organization follows best practices and meets or exceeds regulatory requirements. ISO 9001:2015 document control mitigates risks by establishing a clear process for document approval, review, distribution, and change control. This minimizes the likelihood of non-compliance and costly errors and enhances organizational efficiency by facilitating easy access to up-to-date information.
By implementing ISO 9001:2015 document control, organizations also gain a competitive edge. They can more readily adapt to changing market demands, improve customer satisfaction, and reduce operational inefficiencies. This standard fosters a quality culture where employees pursue excellence, driving innovation and growth.
Establishing an efficient ISO document control system entails the following steps:
Develop Document Control Procedures:
Create and document a comprehensive set of procedures that outline the essential aspects of your ISO document control system, encompassing document identification, approval, distribution, storage, and change control.
Designate Responsibilities:
Assign specific individuals or roles responsible for document management, approval, and review. Ensure they receive proper training and comprehend their roles effectively.
Utilize Standard Templates:
Implement standardized document templates to ensure consistency and simplify usage across the organization, fostering a uniform and professional look for all documents.
Adopt Version Control:
Implement a version control system to manage and monitor document revisions effectively, guaranteeing the circulation of only the latest and approved versions.
Conduct Audits and Reviews:
Regularly perform audits and reviews of your document control system to pinpoint areas for improvement and update procedures as necessary.
Develop Document Control Procedures:
Create and document a comprehensive set of procedures that outline the essential aspects of your ISO document control system, encompassing document identification, approval, distribution, storage, and change control.
Designate Responsibilities:
Assign specific individuals or roles responsible for document management, approval, and review. Ensure they receive proper training and comprehend their roles effectively.
Utilize Standard Templates:
Implement standardized document templates to ensure consistency and simplify usage across the organization, fostering a uniform and professional look for all documents.
Adopt Version Control:
Implement a version control system to manage and monitor document revisions effectively, guaranteeing the circulation of only the latest and approved versions.
Conduct Audits and Reviews:
Regularly perform audits and reviews of your document control system to pinpoint areas for improvement and update procedures as necessary.
CQ Works Great and is a Pleasure to Use
We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.
Helen Cary, Document Control Specialist
Benefits of Using CQ’s Quality Management Document Control Software
ComplianceQuest Document Control Software is designed to ensure the document management process is streamlined to meet regulatory needs, while also allowing users to handle documents efficiently.
Streamline Quality Documentation Process Ensuring the timely and efficient approval of quality documents is paramount for any successful business. However, organizations struggle with approvals as the documents are stored in various locations. CQ’s Document Control Software has a centralized repository for all documents making creation, import, and retrieval of documents effortless.
Schedule Periodic Reviews, Revisions, and Reapprovals Rest easy, knowing your quality documents remain current and compliant. ComplianceQuest Document Control software helps organizations meet industry regulations and standards. It has robust reporting capabilities that can be used during audits.
Enforce Precise Quality Document Access ControlsDetermining who should have access to specific quality documents is a crucial aspect of safeguarding sensitive information. CQ’s Document Control Software ensures that authorization to sensitive documents is as per internal data governance and data security policies.
Seamlessly Connect Quality Processes Across the Organization Managing quality processes can be intricate and time-consuming, especially when various departments use different systems to track quality procedures. The software helps meet organization's document retention policies, while ensuring that all documents are archived or removed from the system as per policy requirements.
Automating document management across the enterprise to increase visibility, improve security, and reduce cost with CQ's robust, flexible, and scalable document control software
Document control in Quality Management Systems (QMS) is a critical process that encompasses managing policies, procedures, work instructions, and records. It includes version control, access restrictions, audit trails, and approval workflows. It is fundamental for regulatory compliance, quality assurance, and continual improvement in industries such as healthcare, manufacturing, and finance.
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The time required to implement a Quality Document Management Solution can vary widely depending on several factors, including the complexity of the organization's processes, the size of the document repository, and the chosen software or system. ComplianceQuest offers cloud-based Quality Document Management Solution that is built on Salesforce. Since the entire system is on cloud, the implementation time is reduced considerably from months to mere weeks depending on the type of customization required.
