Regulatory

ISO 13485 Audit Requirements and Checklist

ISO 13485:2016 is one of the most popular international standards that apply to medical device manufacturers and suppliers. Although using the standard is voluntary, the U.S. Food and Drug Administration (FDA) and its counterparts in Canada, Australia, Japan, and the European Union, encourage and expect medical device firms to adhere to the standards. ISO 13485 was updated in 2016 to address technological advances and regulatory changes. The standard covers quality management system essentials, as well as ISO 13485 audit requirements.

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Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview

ISO 13485 Videos

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Free ISO 13485 Audit Resources

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White Paper: ISO 13485 - Change? Do I Have To? White Paper: cGMP and ISO 13485 Integrated Quality Management System White Paper: 6 Must-Haves for a Quality Management System (QMS) White Paper: Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview
Data Sheet: MasterControl Audit
FAQ: 21 CFR Part 820 – ISO 13485 Harmonization

ISO 13485 Audit Requirements and Management

Audit is a key factor that demonstrates compliance with regulatory and customer requirements. Under ISO 13485’s audit requirements, the management team carries the responsibility of making sure regular audits are performed as part of quality management. ISO 13485 auditors hold the management ream accountable for a firm’s quality policies and procedures. Management must provide adequate resources for conducting audits, review audit results, and provide leadership in fostering continuous quality improvement.

ISO 13485 Internal Audit

Medical device manufacturers and suppliers must perform ISO 13485 internal audits on a regular basis as a way to ensure device quality and safety. The ISO 13485 audit section recommends setting up an internal audit program, developing an internal audit procedure, solving problems discovered by audits, and verifying that problems have been solved. Here is a breakdown of ISO 13485 internal audit requirements:

Establish an internal audit procedure

An internal audit process is meant to assess the strength of an organization’s quality processes and uncover any weaknesses. A company’s quality policy should include a formal internal audit program with documentation and implementation components.
Plan the organization’s internal audit program

ISO audit requirements call for a formal audit process, which implies the need for a documented plan that can be shared throughout the organization.
Perform internal audits at planned intervals

ISO standards require regular internal audits. Most companies typically perform it on an annual or semi-annual basis, though the frequency should depend on the organization’s needs.
Keep a record of the audit plan and performance

The documentation aspect of an internal audit program should include policies, procedures, instructions, and records of audits that have been performed.
Implement correction of nonconformances and their causes

Corrective action and preventive action (CAPA) is a crucial aspect of ISO audit procedures. CAPA implementation should be formally documented and its records maintained.
Evaluate steps taken to resolve nonconformances

It’s not enough to correct nonconformances and other quality issues. CAPA also calls for measures to help mitigate and prevent future occurrences of the same quality issues.

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.

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

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

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.
Supplier

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.

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.

Exceed ISO 13485 Auditors’ Expectations

Choose a software solution that exceeds the expectations of ISO 13485 auditors and trusted by regulators. Two divisions of the FDA use MasterControl as their quality management system. They use MasterControl to manage documents, training, change control, and other quality processes.

For more information about MasterControl solutions, contact a MasterControl representative today.

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ISO 13485 Audit Requirements and Checklist

ISO 13485 Videos

Free ISO 13485 Audit Resources

ISO 13485 Audit Requirements and Management

ISO 13485 Internal Audit

Establish an internal audit procedure

Plan the organization’s internal audit program

Perform internal audits at planned intervals

Keep a record of the audit plan and performance

Implement correction of nonconformances and their causes

Evaluate steps taken to resolve nonconformances

ISO 13485 Audit Checklist

An ISO Audit Checklist is Useful for all Types of Audits

Internal

External

Supplier

External Recertification

Develop Your Own ISO 13485 Checklist with MasterControl Audit™

Simplify audit planning

Reduce audit preparation time

Consolidate data

Exceed ISO 13485 Auditors’ Expectations

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