ISO 13485 Audit Checklist

Confirming your compliance with global quality assurance standards, such as the International Organization for Standardization (ISO) 13485, involves stringent and complex audit and certification processes. While audits are challenging, you can simplify them, as well as improve your chances of success, by creating an ISO 13485 audit checklist.

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ISO 13485 Checklist Overview

Originally published in 1996, ISO 13485 is a quality management standard specifically designed to harmonize the international regulatory requirements of medical devices and related products. Major revisions of the ISO 13485 standard were published in 2003 and again in 2016. These revisions include guidelines that apply specifically to suppliers and manufacturers of medical device components. The standard also emphasizes that manufacturers are expected to apply a risk-based approach to all quality processes, which reiterates the value of an ISO 13485 checklist.

An ISO Audit Checklist is Useful for all Types of Audits

Internal audits are conducted by employees or outside consultants using an internal audit checklist to evaluate a product, service, process, or entire system.

External audits are conducted by a third-party organization, which is common for medical device audits. Upon successful completion of the audit, the company usually receives a certificate of compliance.

A supplier audit is an external audit of a supplier organization, conducted either by the customer or an external auditor on behalf of the customer.

External Recertification External ISO 13485 recertification audits are completed every three years. Internal and supplier audits are more frequent to help maintain the same level of quality demonstrated during the certification audits.

Does ISO 13485:2016 Mention an Audit Checklist?

Clause 8 of the ISO 13485 addresses the importance of audits, citing that a manufacturer must plan and perform internal audits on a regular basis. The audit plan includes an ISO 13485 audit checklist of required tasks. The format of the checklist encourages the auditor to document objective evidence of compliance based on the organization’s processes, characteristics of the processes, and the requirements of the audit standard. The lead auditor commonly creates and maintains the audit checklist.

Develop Your Own ISO 13485 Checklist with MasterControl Audit™

MasterControl Audit enables you to create multiple checklists for different audit types (internal, external, supplier, recertification) and regulatory requirements. Auditors can complete checklists online, offline in a Microsoft Word document, and on a mobile device. MasterControl’s audit solution enables you to:

  • Simplify audit planning: Effortlessly plan and manage audit schedules using MasterControl’s drag and drop calendar. Capture and maintain associated findings, report on the resulting data, and create final audit reports.

  • Reduce audit preparation time: Create robust audit reports using rich text data maintained from auditor entry to peer review through automated report generation.

  • Consolidate data: Global audit teams can access audit checklists and other important audit information from virtually anywhere.

Benefits of Using MasterControl Audit

MasterControl Audit is the ideal solution for companies of all sizes that need to ensure compliance with a diverse set of regulations and standards across a global supply chain.

Easily connect and collaborate with other internal and external auditors, suppliers, and other stakeholders involved in the audit process using familiar tools, such as Microsoft Office applications.

Use powerful online analytics and reporting tools, including customizable reports and online charting, to get a real-time view of all audit processes to better understand where issues are occurring. Streamline resolutions by launching CAPAs or SCARs directly from an audit finding.

QMS Provider for the FDA

The U.S. Food and Drug Administration (FDA) implemented MasterControl in 2009 to improve the quality processes of the Office of Regulatory Affairs (ORA). Since that time, the FDA expanded its implementations and continues to use a variety of MasterControl’s Quality Excellence™ solutions across all of the ORA’s business units.

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