ISO 13485 is a quality management standard that applies to medical device companies. ISO 13485 audit requirements are outlined in Clause 8 of the standard and define the remedial processes necessary to maintain an effective quality management system (QMS). Clause 8 notes that internal audits are necessary to monitor and measure quality. The latest version of the standard, ISO 13485:2016, includes a new audit requirement at the end of Clause 8. It calls for audit data to be examined for trends, e.g., a spike in complaints related to shipping, which could indicate a larger problem. ISO 13485:2016 supersedes ISO 13485:2003 and ISO 13485:1996.
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Although ISO 13485 certification is voluntary in the U.S., it is considered a necessity for any U.S.-based manufacturer hoping to market its devices globally. This is because ISO 13485 is required in many countries, including Europe and Canada. Companies that adhere to ISO 13485 standards find it easier to address the requirements of the applicable Medical Device Directive (MDD) and CE marking process. The FDA has its own regulatory requirements for medical devices, the FDA Quality System Regulation (QSIT), also known as cGMP.
According to ISO 13485, auditing is critical as part of remedial processes for ensuring conformance and maintaining quality. "Remedial" does not only refer to fixing quality issues, but also covers a broader concept that includes gathering customer feedback, internal audits, and establishing a procedure for handling nonconforming products.
The ISO 13485 audit section (Clause 8) recommends that medical device manufacturers "plan and perform regular internal audits." It recommends setting up an internal audit program; developing an internal audit procedure; solving problems discovered by audits; and verifying that problems have been solved. Another section of standard mentions audits as a tool for maintaining the effectiveness of a quality management system.
To be effective, audits must be performed regularly. MasterControl Auditâ„¢ is an automated solution designed to make regular audits faster, easier and more effective. It is widely used by companies to comply with various regulations (FDA, MHRA, EMA, and MHLW), guidelines (Annex 11, ICH), and ISO standards. The following MasterControl features address ISO 13485 audit requirements:
Increased Efficiency: MasterControl eliminates the legwork in the planning and scheduling of audits. It automates assignment of ISO 13485 audit tasks, as well as tracking, follow-up, escalation, review and approval of those tasks. Scheduling of audits is automatic, so agendas and checklists can be completed well in advance.
Streamlined Process: MasterControl's best practice forms help streamline the ISO 13485 audit process, from collection of data to tracking of findings. Auditors and process owners can add their input directly into the forms for a faster workflow.
Transparency: The entire quality system is visible to auditors because users' actions are captured by a time-stamped audit trail. MasterControl also features robust analytics and reporting tools (including customizable reports) that give managers a real-time view of issues and help them resolve issues in a timely manner.
Risk Management: Regular audits complement a company's overall risk management program because audit findings help identify issues that could have broader implications of risks. While previous versions of ISO 13485 ask manufacturers to apply risk management methods to design controls, ISO 13485: 2016 requires that a risk-based approach be applied to all QMS processes, including auditing.
Connectivity: MasterControl connects the audit process with other quality processes, such as document control, training control, CAPA, customer complaints, and change control. This connectivity gives managers the ability to view ISO 13485 audit requirements as part of the company's overall compliance effort. Connectivity also allows them to monitor the entire quality system more effectively.
Cost-effective: MasterControl helps increase efficiency, optimize productivity, and reduce the time and effort involved in compliance, all of which contribute to lower compliance cost.
Increased Customer Satisfaction and Retention: MasterControl solutions help device makers sustain delivery of high-quality products. As consumers grow more sophisticated and competition continues to increase, companies able to demonstrate product superiority by, for example, satisfying ISO 13485 audit requirements and obtaining ISO 13485 certification, will be in a better position to win sales and retain customers.
To learn more about ISO 13485 audits or the MasterControl Audit software solution, please contact a MasterControl representative.