Few industries need quality control as much as the world of medical devices. Medical device quality system auditing takes the job one step further by ensuring the process itself holds up to critical standards. Here are 5 things you can expect when a medical device quality system auditing services provider evaluates a system.
ISO Standards
The guiding lights of the auditing process will be two ISO standards. Foremost, the ISO 13845 standard governs issues specific to quality control and medical devices. The last revision appeared in 2016, and it guides organizations of all sizes. It governs everything in the life cycle of a medical device, including the design, development, production, and setup of the device. It even extends to issues involving storage and supply.
The broader ISO 9001 also applies. It is the general quality control standard for all organizations, even those that don't deal with medical systems. However, within medical device quality system auditing, the focus will be on how organizational quality control affects medical systems.
FDA Standards
Medical devices in the US must also comply with federal standards. In these cases, the FDA provides further guidance.
Who Initiates Audits
Any interested party can initiate an audit. This includes governing agencies that process notifications regarding the certification of devices. Third parties with interests in the devices also can request them. For example, a company contracting the production of a device can request an audit of a supplier. Internal audits are okay, too.
Times for Audits
Audits fall into four categories.
Agencies may also conduct unannounced audits.
How the Audit Goes
The requesting party will appoint or hire an auditor. The auditor has broad rights to obtain documents from parties covering compliance with the ISO and FDA standards. An auditor will want to access digital systems to see records and processes. A company's testing regime, for example, is subject to auditing if there are quality control concerns. It's prudent to have all software and documents readily available to speed up auditing.
Upon completion of the audit, the auditor will produce a report. Ideally, everything is good and the auditor certifies the device. If not, the auditor can issue a warning or recommend revocation of certifications.