What is Document Control and why is it necessary?
What is “document control?”
Document control for medical devices is the process of managing and maintaining the documents related to the design, development, production, and use of a medical device. This includes creating, reviewing, approving, distributing, and archiving documents such as specifications, test plans, and user manuals. The purpose of document control is to ensure that the correct version of a document is being used, that the information in the document is accurate and up-to-date, and that the document is readily accessible to those who need it. It also helps to ensure compliance with regulatory requirements for medical devices.
Why is document control for medical devices necessary?
Document control is necessary for several reasons:
Compliance: Medical devices are regulated by government agencies such as the FDA in the US, and document control is necessary to ensure compliance with the regulations and standards set by these agencies.
Quality: Document control helps to ensure that the correct version of a document is being used, and that the information in the document is accurate and up-to-date. This helps to ensure the quality of the medical device and reduce the risk of errors or defects.
Traceability: Document control helps to ensure that there is a clear and traceable history of the development and production of a medical device. This can be important in case of an investigation or recall of a device.
Collaboration: Document control allows multiple teams and individuals to work together on a project by providing a central location for storing and sharing documents.
Auditing: Document control helps in the process of auditing, by keeping the records of all documents, changes, approvals, and distribution. This helps to demonstrate compliance with regulations, and to quickly access the necessary information during an audit.
Is document control required for ISO 13485 compliance?
Yes, document control is required for ISO 13485 compliance. ISO 13485 is an international standard that specifies the requirements for a quality management system for the design, development, production, and distribution of medical devices. One of the requirements of the standard is that an organization must establish, implement, and maintain a document control process.
This includes:
Identifying the documents required by the quality management system and the organization,
Reviewing and approving the documents before issue,
Ensuring that the documents are legible, readily identifiable, and retrievable,
Ensuring that the documents are current and that any obsolete documents are removed or clearly identified as such,
Ensuring that the changes and the current revision status of documents are identified,
Providing access to the documents to the personnel who need them.
The purpose of this requirement is to ensure that the correct version of a document is being used, that the information in the document is accurate and up-to-date, and that the document is readily accessible to those who need it. It also helps to ensure compliance with the standard and regulatory requirements for medical devices.
Is document control required by the FDA?
Yes, document control is required by the FDA for medical device manufacturers. The FDA has a set of regulations, known as the Quality System Regulation (QSR), that outline the requirements for a quality management system for the design, development, production, and distribution of medical devices.
The QSR requires that manufacturers establish, implement, and maintain a document control process that includes:
Identifying the documents required by the quality management system and the organization
Reviewing and approving the documents before issue
Ensuring that the documents are legible, readily identifiable, and retrievable
Ensuring that the documents are current and that any obsolete documents are removed or clearly identified as such
Ensuring that the changes and the current revision status of documents are identified
Providing access to the documents to the personnel who need them
The purpose of this requirement is to ensure that the correct version of a document is being used, that the information in the document is accurate and up-to-date, and that the document is readily accessible to those who need it. It also helps to ensure compliance with the FDA regulations and requirements for medical devices.
It is important to note that the FDA conducts regular inspections to ensure compliance with the QSR, and manufacturers are expected to demonstrate that they have a robust and effective document control process in place.
