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ISO 13485 Quality Management System Audit Checklist

A comprehensive checklist for auditing quality management systems in medical device manufacturing to ensure compliance with ISO 13485 standards and improve overall quality and safety in healthcare organizations.

ISO 13485 Quality Management System Audit Checklist

by: audit-now
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About This Checklist

The ISO 13485 Quality Management System Audit Checklist is an essential tool for healthcare organizations to ensure compliance with international standards for medical device quality management. This comprehensive checklist addresses key aspects of the ISO 13485 standard, helping organizations identify gaps in their quality management processes, improve patient safety, and maintain regulatory compliance. By systematically evaluating your quality management system, you can enhance product quality, reduce risks, and streamline operations in the medical device industry.

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Industry

Healthcare

Standard

ISO 13485 - Medical Device Quality Management

Workspaces

Medical Device Manufacturing Facilities

Occupations

Quality Manager
Auditor
Regulatory Affairs Specialist
Medical Device Engineer
Quality Assurance Specialist
1
Is there a documented procedure for document control?
2
What percentage of personnel training has been completed?
Min: 0
Target: 100
Max: 100
3
Is there a risk management process in place?
4
Have internal audits been conducted as per schedule?
5
Are quality control procedures documented and followed?
6
How many non-conformance reports were issued in the last quarter?
Min: 0
Target: 0
7
Describe any corrective actions taken to address quality issues.
8
When was the last quality audit conducted?
9
Is there a process for reporting patient safety incidents?
10
What percentage of patient complaints were resolved within the last month?
Min: 0
Target: 100
Max: 100
11
Have staff members received training on patient safety protocols?
12
Describe any recent patient safety improvement initiatives implemented.
13
Are all regulatory compliance documents up to date?
14
How many regulatory audits were conducted in the last year?
Min: 0
Target: 0
15
Has compliance training been provided to all relevant staff?
16
Describe actions taken to address any non-compliance issues identified.
17
Is there a documented supplier qualification process in place?
18
How many supplier performance reviews were conducted in the last year?
Min: 0
Target: 0
19
Have corrective actions been implemented for suppliers with performance issues?
20
Describe any improvement initiatives undertaken with suppliers.

FAQs

The primary purpose is to assess and ensure compliance with the ISO 13485 standard for quality management systems in the medical device industry, helping organizations maintain high-quality standards and regulatory compliance.

ISO 13485 audits should be conducted at least annually, with some organizations opting for more frequent internal audits to ensure continuous compliance and improvement.

This checklist should be used by quality managers, auditors, regulatory affairs specialists, and other professionals responsible for maintaining quality management systems in medical device manufacturing and healthcare organizations.

The checklist covers various aspects of the quality management system, including management responsibility, resource management, product realization, and measurement, analysis, and improvement processes.

By ensuring compliance with ISO 13485 standards, the checklist helps organizations maintain rigorous quality control processes, reducing the risk of defective medical devices and improving overall patient safety.

Benefits of ISO 13485 Quality Management System Audit Checklist

Ensures compliance with ISO 13485 requirements

Improves quality management processes in medical device manufacturing

Reduces risks associated with non-conformance

Enhances patient safety through systematic quality control

Facilitates continuous improvement in healthcare organizations