Document Control Procedure

For any type of quality management system, whether within the medical device sector or not, having an established document control process and procedure it is essential. The quality system is mainly based on documentation and without an appropriate process to deal with this whole set of documents, it is not possible to efficiently manage the processes within a quality system.

According to ISO 13485:2016, there are specific requirements which are related to the management of the documentation. These requirements are defined in the sections:

• 4.2.4 for the management of documented procedures
• 4.2.5 for the management of records, which are considered a particular type of documents.

Similar requirements are present for the FDA Quality System Regulation 21 CFR 820.

Requirements for QMS Procedures

The Document Control Procedure shall define the requirements for the management the procedures of the quality management system.

The requirements for QMS procedures can be summarised as below:

• procedure shall be reviewed and approved before
• when procedures are modified, they shall be reviewed again and re-approved
• revision status of the document and the changes to the document shall be clearly identified
• the current version of the document shall be easily accessible
• document shall be legible
• external documents are managed in such a way they are identified and their distribution is controlled
• deterioration and loss of documents shall be prevented
• unintended use of obsolete documents shall be prevented.

Requirements for Records

Another topic of fundamental importance that shall be clarified within the Document Control Procedure is Records Management. Records are a particular types of documents used to provide evidence of conformity to all the applicable regulatory requirements. The main requirements associated to a record shall be summarised as follows:

Changes of record shall remain identifiable. Moreover, methodology to protect confidential health-related information on records shall be properly implemented.

Retention Period

One of the key characteristics for QMS procedures and Records is their retention period, thus the amount of time that the specific document shall be retained by the organization. Procedures and records have different requirements for the retention period based on the applicable regulatory requirements.

For Procedure ISO 13485:2016 requires the organization to define the retention period for obsolete version of documents; this retention period shall be ensure availability of documents at least during the lifetime of the devices on the market.

For records, requirements are similar however it is clearly specify that records shall have at least a retention time of 2 years, independently from the lifetime of the product.

Document Control Procedure

As mentioned before, the Document Control Procedure is at the base of any Quality Management System and it is of fundamental importance for the management of the whole QMS documentation.

Subscribe to 4EasyReg Newsletter

4EasyReg is an online platform dedicated to Regulatory matters within the medical device, information security and AI-Based business.

We offer a wide range of documentation kits to support your compliance efforts towards a wide range of standards and regulations, such as ISO 13485, EU MDR, ISO 27001, ISO 42001 and much more. . Specifically, in our webshop you will find:

• ISO 13485 Documentation / Compliance Kit
• ISO 27001 Documentation / Compliance Kit
• ISO 42001 Documentation / Compliance Kit
• FDA Cybersecurity Documentation

Within our sister platform QualityMedDev Academy, a wide range of online & self-paced training courses is available, such as for example:

• Complaint Handling and Vigilance Reporting
• Artificial Intelligence in Medical Device. Regulatory Requirements
• Unique Device Identification (UDI) Requirements according to EU MDR
• Clinical Evaluation Process According to EU MDR
• Medical Device SW Verification & Validation
• Risk Management for Medical Devices
• Usability Evaluation for Medical Devices

As one of the leading online platforms in the medical device sector, 4EasyReg offers extensive support for regulatory compliance. Our services cover a wide range of topics, from EU MDR & IVDR to ISO 13485, encompassing risk management, biocompatibility, usability, software verification and validation, and assistance in preparing technical documentation for MDR compliance.

Do not hesitate to subscribe to our Newsletter!