Medical device companies that wish to sell devices in Europe must establish a QMS manual that meets the requirements of the ISO 13485:2016 standard.
One of the key differences between the quality system requirements outlined in 21 CFR Part 820 and the ISO 13485:2016 medical device quality standard has to do with companies establishing a quality manual. Under the ISO standard, the QMS manual is a required document that acts as a table-of-contents for your quality management system, explaining the purpose and objectives of the device, and explaining to the end user where certain information about the product is located. The phrase "quality manual" does not appear in the FDA QSR, but medical device companies may still find it useful to establish a quality manual that
- communicates the purpose and objectives of the quality management system to employees of the company,
- acts as a starting point for auditors, indexing information in the QMS and making it easier for auditors to navigate, and
- establishes roles and responsibilities for maintaining the QMS and performing quality-related activities.
What is a QMS Manual?
A QMS manual, or quality manual, contains the specifications for the quality management system of an organization. Quality manuals were first required by the ISO 9001 standard for quality management systems, the document from which the ISO 13485:2016 medical device quality standard was derived.
A quality manual is a tool for navigating the company's quality management system. It states the company's goals and objectives for the quality management system and may define management responsibilities for various activities required.
What are the ISO 13485 QMS Manual Requirements?
Under the ISO 13485:2016 standard, medical device companies can choose what information to include in their QMS manual as long as it meets the minimum requirements. These are the four key topics that should be covered to comply with the standard.
1. Description of Document Structure
A QMS manual should describe how the documents contained in the QMS are structured. Envision the document structure within your QMS as a pyramid. At the top of the pyramid are the most high-level documents that describe the quality policy, roles and responsibilities and process flows in the QMS - essentially everything that belongs in the quality manual. The next level down in the pyramid consists of standard operating procedures (SOPs) and work instructions that describe your manufacturing processes. The base of the pyramid is comprised of the documentation and records that are produced during the execution of those processes.
Your quality manual should contain a detailed schematic overview of how documents are categorized within the QMS, making it easy for an internal or external auditor to quickly find the information they need.
2. Scope of the Quality Management System
The scope of the quality management system should be defined in the QMS manual. Medical device companies should identify the manufacturing facility that will be included in the QMS and what specific medical device development activities are performed there.
3. References to Documented Procedures
A typical medical device company has hundreds of SOPs, describing everything from documentation procedures to manufacturing processes. Quality manuals should not go into detail on individual SOPs, but they should act as an index or reference tool for someone that is searching your company QMS for a particular SOP.
4. Process Interactions and Work Flows
The quality manual should briefly describe the processes that operate within the QMS and how they interact with each other.
Digitize Your QMS Manual with Greenlight Guru's Medical Device QMS Software
Greenlight Guru is purpose-built to help medical device companies comply with the quality and regulatory standards. With Greenlight Guru's medical device QMS software, companies can create and securely store a QMS manual through the document management workflows that seamlessly link together every process within the QMS, ensuring true quality medical devices are produced and brought to market, safer and faster.