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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

Workspaces

Medical Device Manufacturing Facility

Occupations

Quality Manager
Auditor
Regulatory Affairs Specialist
Medical Device Engineer
Quality Assurance Specialist

Quality Management System Assessment

(0 / 4)

1
Have internal audits been conducted as per schedule?

Indicate whether internal audits have been conducted.

To ensure that internal audits are performed regularly to maintain compliance with the QMS.
2
Is there a risk management process in place?

Select the status of the risk management process.

To verify that risks are identified and managed appropriately in compliance with ISO 13485.
3
What percentage of personnel training has been completed?

Enter the percentage of completed training.

To assess compliance with training requirements for personnel involved in the QMS.
Min: 0
Target: 100
Max: 100
4
Is there a documented procedure for document control?

Select whether the document control procedure is documented.

To ensure that the organization maintains control over documents as per ISO 13485 requirements.
5
When was the last quality audit conducted?

Select the date of the last quality audit.

To track the frequency of quality audits for compliance and improvement.
6
Describe any corrective actions taken to address quality issues.

Provide details of corrective actions.

To ensure that appropriate corrective actions are implemented to prevent recurrence of quality issues.

Enter actions here...

7
How many non-conformance reports were issued in the last quarter?

Enter the number of non-conformance reports.

To monitor and evaluate the frequency of non-conformances as part of quality control.
Min: 0
Target: 0
8
Are quality control procedures documented and followed?

Select the status of quality control procedures.

To confirm that quality control procedures are in place and adhered to, ensuring product quality.
9
Describe any recent patient safety improvement initiatives implemented.

Provide details of safety improvement initiatives.

To assess ongoing efforts to improve patient safety and prevent incidents.

Enter initiatives here...

10
Have staff members received training on patient safety protocols?

Indicate whether training on patient safety protocols has been provided.

To ensure that all staff are adequately trained on patient safety measures.
11
What percentage of patient complaints were resolved within the last month?

Enter the percentage of resolved patient complaints.

To evaluate the organization's responsiveness to patient complaints and enhance patient satisfaction.
Min: 0
Target: 100
Max: 100
12
Is there a process for reporting patient safety incidents?

Select the status of the incident reporting process.

To ensure that all patient safety incidents are reported and managed to improve overall safety.
13
Describe actions taken to address any non-compliance issues identified.

Provide details of actions taken for non-compliance.

To verify that appropriate actions are implemented to rectify non-compliance and prevent recurrence.

Enter actions here...

14
Has compliance training been provided to all relevant staff?

Indicate whether compliance training has been provided.

To ensure that all staff members understand and comply with regulatory requirements.
15
How many regulatory audits were conducted in the last year?

Enter the number of regulatory audits conducted.

To monitor the frequency of regulatory audits for maintaining compliance.
Min: 0
Target: 0
16
Are all regulatory compliance documents up to date?

Select the status of regulatory compliance documentation.

To ensure that the organization maintains current documentation for compliance with regulatory requirements.
17
Describe any improvement initiatives undertaken with suppliers.

Provide details of supplier improvement initiatives.

To assess collaborative efforts to enhance supplier performance and quality.

Enter initiatives here...

18
Have corrective actions been implemented for suppliers with performance issues?

Indicate whether corrective actions have been implemented for suppliers.

To ensure that corrective actions are taken to address supplier performance deficiencies.
19
How many supplier performance reviews were conducted in the last year?

Enter the number of supplier performance reviews conducted.

To monitor the frequency of supplier performance evaluations and ensure ongoing compliance.
Min: 0
Target: 0
20
Is there a documented supplier qualification process in place?

Select the status of the supplier qualification process.

To ensure that suppliers are evaluated and qualified to meet the organization's quality standards.

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

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