ISO 13485 Audit Checklist

An ISO 13485 audit checklist is an indispensable resource when auditing your quality management system. With Certainty software’s customizable inspection forms and tracking feature, performing compliance inspections becomes much simpler.

ISO 13485 stipulates that top management must support its quality policy and Pro QC’s auditors examine evidence of this during an ISO 13485 audit. They include validating folders as evidence.

Requirement 1: Documentation

Perform an internal audit as part of your medical device Quality Management System (QMS). Utilizing Qualio’s free ISO 13485 Audit Checklist, conduct internal audits regularly to identify areas for process enhancement and ensure compliance.

This checklist provides an exhaustive list of requirements outlined by ISO 13485 standard and helps assess whether your QMS complies with them, while providing insight into whether or not a third-party ISO 13485 certification audit may be forthcoming.

The first part of the checklist focuses on documentation and records. This section includes procedures for identifying, protecting, retrieving, making available to staff and auditors documents available as well as approval, distribution and changes. Furthermore, this ensures documents are legible and identifiable as well as being stored appropriately.

Requirement 2: Monitoring

All processes involved in manufacturing medical devices must be closely monitored to ensure they are functioning as intended, using internal audits or records reviews as tools of surveillance.

Goal of process auditing: to make sure processes are operating as planned while still meeting ISO 13485 quality standards and regulatory requirements. Utilizing data from these processes can assist with improving internal procedures and avoiding nonconformances in future.

Lumiform can make this task simpler by making it simple for internal auditors to document and track their work. Utilizing its powerful form builder, documents can easily be digitized within minutes. This reduces time needed for preparation of 3rd party audits while helping pass them with ease by showing compliance.

Requirement 3: Training

Training is an integral component of ISO 13485 quality management systems. It ensures that staff understand their responsibilities in processes they are accountable for and their role within them, and allows them to identify any noncompliance issues and implement corrective actions efficiently.

Medical device companies without ISO 13485 certification cannot access many international markets. Therefore, it is vitally important that they develop and implement an extensive training program for their staff.

Training must meet all of the requirements set forth by ISO 13485. This training must cover everything from its fundamentals to medical device processes and procedures that must be strictly adhered to, corrective action taken against deviations, as well as how to validate improvements within your quality management system.

Requirement 4: Corrective Action

Medical devices affect health and safety more than most products; therefore their quality must be of the highest order. National and international regulatory agencies mandate medical device manufacturers have a quality management system certified by an external auditor.

Implementing an ISO 13485 audit checklist helps streamline internal quality checks, preparing you for third-party inspection. A digital quality audit checklist also offers you the capability of tracking and reporting on findings across an enterprise level.

Quality processes like audits, CAPAs, supplier evaluation and change control can be easily managed using a digital QMS like Qualio. Our solution helps ensure compliance and lets you pass ISO 13485 audits with flying colors!

Requirement 5: Evaluation

Companies who do not adhere to ISO 13485 standards face the threat of losing access to key markets. To minimize delays in market entry and minimize cost implications, medical companies must keep their documentation in order. Internal quality management teams use tools like an internal audit checklist that facilitate this task.

This checklist helps companies assess their readiness for third-party auditing, while highlighting areas for improvement within their existing QMS that could enable an upgrade to ISO 13485:2016.

Certainty Software makes conducting compliance inspections and ISO audits simpler by providing customizable checklists, tracking results and creating reports – an indispensable tool that ensures your organization stays compliant year-round while passing audits effortlessly.