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Medical Device Manufacturing Process Audit Checklist

A detailed checklist for auditing medical device manufacturing processes to ensure compliance with ISO 13485 standards, focusing on production quality, consistency, and safety in healthcare product manufacturing.

Medical Device Manufacturing Process Audit Checklist

by: audit-now
4.1

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About This Checklist

The Medical Device Manufacturing Process Audit Checklist is an indispensable tool for healthcare organizations to ensure compliance with ISO 13485 standards in their production processes. This comprehensive checklist addresses critical aspects of medical device manufacturing, including process validation, equipment maintenance, and contamination control. By implementing this checklist, manufacturers can identify potential issues in their production lines, improve product consistency, and maintain the highest standards of quality and safety. Regular audits using this checklist help organizations minimize manufacturing defects, reduce recalls, and ultimately enhance patient safety in the healthcare industry.

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Industry

Healthcare

Standard

ISO 13485 - Medical Device Quality Management

Workspaces

Medical Device Manufacturing Facilities

Occupations

Quality Assurance Manager
Manufacturing Engineer
Production Supervisor
Regulatory Compliance Specialist
Process Validation Engineer
1
Is the device validation status compliant with ISO 13485 standards?

Select the compliance status of device validation.

To ensure that the validation processes meet regulatory requirements.
2
What are the current contamination levels (in CFU/m³) in the manufacturing area?

Enter the contamination levels in CFU/m³.

To monitor contamination and ensure it is within acceptable limits.
Min: 0
Target: 0
Max: 100
3
How would you rate the overall production quality of the manufactured devices?

Select the production quality rating.

To assess the quality of the manufacturing process.
4
Was the quality control process followed during production?

Indicate if the quality control process was followed.

To ensure adherence to quality standards.
5
Is the manufacturing process compliant with all applicable regulations?

Select the regulatory compliance status.

To verify compliance with regulatory standards in medical device manufacturing.
6
Please provide details of any incidents reported during the manufacturing process.

Enter incident details.

To document any deviations or issues that occurred.
7
What is the current defect rate (%) observed in the manufacturing process?

Enter the defect rate as a percentage.

To assess the quality of the production process and identify trends.
Min: 0
Target: 0
Max: 10
8
When was the last regulatory compliance audit conducted?

Select the date of the last audit.

To track the frequency of compliance audits.
9
Is the validation protocol approved by the relevant authorities?

Select the approval status of the validation protocol.

To ensure all validation protocols meet compliance standards.
10
Provide a summary of the validation test results.

Enter a detailed summary of the validation test results.

To document the outcomes of validation tests performed.
11
What is the sample size used for the validation tests?

Enter the number of samples used for validation.

To ensure that the sample size meets the statistical requirements for process validation.
Min: 1
Target: 30
Max: 100
12
Is revalidation required based on the current findings?

Indicate if revalidation is needed.

To determine if revalidation is necessary for the manufacturing process.
13
Is the Quality Management System (QMS) compliant with ISO 13485 requirements?

Select the compliance status of the Quality Management System.

To ensure that the QMS adheres to the necessary standards for medical device manufacturing.
14
List any corrective actions taken to address non-conformities in the QMS.

Enter details of corrective actions taken.

To document responses to identified issues within the QMS.
15
How often are internal audits conducted (in months)?

Enter the frequency of internal audits in months.

To assess the regularity of internal audits as part of the QMS.
Min: 1
Target: 6
Max: 12
16
When was the last management review meeting held?

Select the date and time of the last management review.

To ensure that management reviews are conducted regularly for effective oversight.
17
Is the supplier certified to ISO 13485 or equivalent standards?

Select the certification status of the supplier.

To ensure that suppliers meet necessary quality standards for medical device components.
18
Provide a summary of the supplier's performance over the last year.

Enter a detailed performance review of the supplier.

To evaluate supplier reliability and quality of supplied components.
19
What is the defect rate (%) of components received from the supplier?

Enter the defect rate as a percentage.

To assess the quality of incoming materials and identify trends in defects.
Min: 0
Target: 0
Max: 10
20
When was the last audit of the supplier conducted?

Select the date of the last supplier audit.

To ensure that supplier audits are performed regularly for compliance.

FAQs

The checklist covers areas such as process validation, equipment calibration and maintenance, material handling and storage, contamination control, production and process controls, packaging and labeling, and product release procedures.

It includes specific items to verify proper cleanroom practices, personnel hygiene protocols, environmental monitoring, and contamination control measures throughout the manufacturing process.

The audit should be conducted by trained quality assurance personnel, manufacturing engineers, or third-party auditors with expertise in medical device manufacturing and ISO 13485 requirements.

Manufacturing process audits should be conducted at least annually, with more frequent audits recommended for critical processes or when significant changes are implemented in the production line.

Non-compliance can lead to product quality issues, regulatory sanctions, costly recalls, damage to company reputation, and most importantly, potential harm to patients using the medical devices.

Benefits of Medical Device Manufacturing Process Audit Checklist

Ensures compliance with ISO 13485 manufacturing requirements

Improves consistency and quality in medical device production

Reduces the risk of manufacturing defects and product recalls

Enhances traceability throughout the production process

Facilitates continuous improvement in manufacturing operations