ISO 13485/21 CFR 820 Quality Management System (QMS)
A Quality Management System (QMS) is used by an organization involved in one or more stages of the life cycle of a medical device (MD) or in vitro diagnostics medical device (IVD MD).
Find out why organizations choose to implement ISO 13485/21 CFR 820-compliant QMS
Fulfill legal requirements to operate under a QMS
All medical device regulations worldwide require the manufacturer of medical devices to operate under a quality management system. You can enter and operate in this market by implementing an ISO 13485/21 CFR 820-compliant QMS.
Maximize medical device benefits and lower its risk to a patient
With medical devices, you can offer benefits for the end users. At the same time, the organization must reduce the risk of their usage. Medical devices are safety-critical systems where an error can result in death or serious injury to people. The QMS setup introduces the ISO 14971-compliant risk management system to help you to achieve these goals.
Build awareness about building, delivering, and maintaining MD-type products
Working with safety-critical systems like medical devices takes awareness, process, and embedding industry experience and lessons learned into medical device products and the operations of companies that deliver them. Only a few people have a track record in this industry. Hence building their awareness and skills is one of the critical goals for the QMS.
Enable the organization to place products on the market
To put a medical device on the market, you must undergo a conformity assessment process. Part of the process is checking if the organization operates under a defined and certified QMS. A robust QMS allows you to fulfill that requirement and makes the conformity assessment process easier to control.
Mitigate the potential liabilities costs
You increase product quality by building a robust and effective quality management system. Monitoring your QMS and MD products under surveillance allows you to react faster to adverse events. Medical device manufacturers reduce potential liabilities by setting an effective QMS.
How it works
Learn about the basics of operating the QMS
A quality management system is a complete set of interlinked policies, processes, procedures, document templates, and roles that are engaged in their execution, describing the way the company operates. The system helps to manage the organization so that safe, fit-for-purpose, and clinically proven medical devices are delivered to end users and patients. The QMS setup defines not only ISO 13485 / 21 CFR 820 but also other harmonized standards relevant to a set of medical devices the organization delivers. The QMS integrates processes and requirements derived from those standards and guidance documents. The organization must appoint a quality manager to supervise its QMS.
The organization and MD-type products operate under a strict risk management system defined in the ISO 1497 standard. The organization manages risk at different levels, such as organizational processes, product risk, software risk, clinical risk, software tools, or manufacturing processes. Risk management aims to maximize MD product benefits and patient safety and minimize adverse risks at every step of an organization’s or product life cycle’s activities.
Medical device product life cycle (PLC)
The QMS is set up to put an MD or IVD MD product on the market. That requires that the organization manages such products along their entire product life cycle (PLC). ISO 13485 / 21 CFR 820 know-how set offers a structure and templates for the complete product documentation throughout its phases. It starts with product planning and sprouts into requirements management, risk management, design and development, purchasing, production, clinical evaluation, product conformity assessment, going live, service provision, installation, servicing, post-market surveillance, and vigilance to end with the product withdrawal. The QMS setup shall reflect and support processes at all stages of the PLC.
Clinical evaluation (MD)/performance evaluation (IVD MD)
To put a medical device or in vitro diagnostics medical device on the market, the organization has to prove its clinical evaluation (MD) or performance evaluation (IVD MD). The part of the QMS is a systematic and planned process to continually generate, collect, analyze, and assess the clinical data of a device to verify its safety and performance, including clinical benefits. Clinical evaluation and performance evaluation require clinical expertise and expert knowledge in its execution. This process is also supported with PLC-specific templates by ins2outs.
When an MD-type product is on the market, as a result of conformity assessment activities, the post-market surveillance and vigilance processes start. The manufacturer and economic operators collect and review experience gained from the devices on the market to identify any need to apply corrective or preventive actions. The vigilance process aims at reporting and sharing objective information with competent national authorities. The manufacturer also executes other PLC-level processes at this stage. All these processes, required roles, and document templates are reflected in the ISO 13485 / 21 CFR 820 know-how set.
Monitoring and improvements
To manage quality, you must monitor and continuously improve it. With the QMS comes the frameworks for monitoring and improving your QMS and your MD/IVD MD products. Internal audits, supplier evaluation, and external QMS certifications provide you with an assessment of your QMS and products’ states.
Define your QMS in 5 steps
Learn how to define and certify the Quality Management System
1. Get know-how
Use your know-how to start the definition of the system or buy ISO 13485 / 21 CFR 820 ready know-how sets
2. Define QMS
Step by step, define your QMS by creating/updating system documentation
3. Share and execute
ins2outs will train your organization users on all finalized documentation. The QMS is used by the organization
4. Certify QMS
Invite a notified body for the certification. Present the QMS documentation in the stage I audit, and execution in stage II
Use your QMS daily. Benefit from tasks automation on ins2outs. Put MD products on the market.
QMS on ins2outs
Get more efficient QMS using ins2outs
ins2outs with the QMS
On ins2outs, you can define your QMS using policies, procedures, instructions, and document templates. Educating your employees is easy with the role-based training paths. All the training is approved with the passwords completed acceptance tasks, fulfilling the nonrepudiation requirement. The “Documents” section of the system enables you to store QMS and product life cycle (PLC) documentation for each MD-type product on the platform. ins2outs is developed and delivered under ISO 13485-certified QMS and ISO 27001-certified ISMS.
ISO 13485 / 32 CFR 820 Know-how setTo speed up the definition step of the QMS, purchase the ISO 13485:2016 / 21 CFR 820 compliant know-how set. The know-how set comprises policies, processes, procedures, instructions, and document templates grouped around the QMS-specific roles and processes. It provides the baseline of the Quality Management System. Finally, it introduces the complete MD / IVD MD product life cycle documentation (PLC) hierarchy and the required documentation templates. The ISO 13485 / 21 CFR 820 how-how set is derived from and linked to the following normative sources: ISO 13485:2016, 21 CFR 820, 21 CFR 830, ISO 14971:2019, IEC 62304-1:2015, EU 2017/745 (MDR), and EU 2017/746(IVDR). It enables your organization to shorten the product path to market and maximize its clinical benefits post-market. Using the know-how set can shorten the QMS definition/certification phase by 75%.
Quality Manager as a Service (QMaaS)To bring the required competencies to your organization, engage one of our experienced Quality Managers. The consultant defines, supervises, and operates your ISO 13485 / 21 CFR 820-compliant Quality Management System. The consultant will lead your QMS certification and support market approvals of your medical devices. As this role is delivered in a service model, you can start or stop it anytime.
ins2outs fit for medical device development
As a medical device manufacturer or a supplier, the organization has to prove that the software it uses for a Quality Management System was developed to medical device standards. With ins2outs, it is easy. The software development and service provision of ins2outs is made under ISO 13485-certified quality management system. As Star, we are a supplier of medical devices and software-related services. Additionally, ins2outs product life cycle activities are conducted under ISO 27001-certified Information Security Management System. Finally, we provide our customers with records from validation and verification activities for each released version or hotfix. Due to that, proving QMS software compliance is easier in front of the incoming audit in your organization.
ins2outs QMS Pricing
Choose any of the following packages to introduce and operate your QMS
ISO 13485 / 21 CFR 820 Know-how set
- Defines ISO 13485 / 21 CFR 820-compliant QMS
- Requires ins2outs account
- One-time net fee
- For organizations of any size
- Experienced Quality Manager
- Delivered via ins2outs
- Monthly net fee
- For organizations with up to 50 users
- Requires one active user account
- Standard features package
- Full view and edit rights