Whether your medical device company is seeking certification with the ISO 13485: 2016 standard or compliance with the FDA QSR, establishing an effective quality management process is one of the first tasks that you will undertake as you bring your medical device to market. Both of these documents discuss quality management in terms of a "quality management system" - a set of quality management processes that, when combined together, result in effective quality management throughout the activities of the organization.
When ISO first established its medical device quality standards in ISO 13485:2003, the methodologies used were heavily adapted from the "process approach" to quality that was characteristic of ISO 9001:2000. Quality management is treated as an ongoing, continually improving process that supports quality in each company's activities from pre-market planning and initial product design through to post-market surveillance activities.
A quality system is more than just documentation, it's a set of functional, ongoing processes designed to consistently produce medical devices that are safe and effective for the end user. When a medical device company is audited, either by the FDA or by a third-party agent (i.e. Notified Body), the auditor will conduct a thorough investigation into the quality management process to determine whether the company has established, and is following, the appropriate policies and procedures. The auditor will likely focus on:
Medical device companies that are required to establish a quality management system to support product safety must appropriately structure oversight and accountability of such a system to ensure that the system is effective and that it is followed where required by all employees at the company. There are several quality management processes that fall under management controls, including management review of the quality system, internal quality audit procedures and the management approval process which applies to all documents in the QMS.
Medical device companies must establish a set of processes known as design controls to help ensure that the medical device
Quality management systems are centered around the Corrective and Preventive Actions (CAPA) process. As an organization collects feedback on its devices, it may become aware of product defects that are caused by errors in the manufacturing, storage or transportation of the medical device. When a nonconformance event occurs, medical device companies must maintain a process for taking corrective action to ensure that the event does not happen again. When a possible source of nonconformance is identified, a preventive action process can be initiated to help ensure that the issue is addressed before it leads to an adverse event.
Manufacturers are responsible for developing, controlling and monitoring processes to ensure that manufactured medical devices conform to the required specifications. There are also quality management processes used to test products for conformance once the manufacturing process has been completed.
Greenlight Guru's eQMS Software was purpose-built for compliance with the quality management process requirements of ISO 13485 and the FDA QSR. With Greenlight Guru, medical device companies can establish and maintain the proper management controls, establish production and process controls that are easily accessible to operators and auditors alike, and seamlessly integrate and manage the design control and CAPA processes to build better, safer products and reduce time to market.