AI Checklist Generator

From the makers of Manifestly Checklists

Email address

Home > Manufacturing > Internal audit

Internal audit

1. Audit Planning

Define the scope and objectives of the audit specific to in vitro diagnostic devices

Identify applicable regulatory requirements (e.g., FDA, ISO 13485)

Review previous audit reports and corrective actions taken

Assemble the audit team with relevant expertise in diagnostics

Develop an audit schedule and logistics plan

2. Regulatory Compliance Review

Verify compliance with medical device regulations and standards

Assess adherence to labeling and marketing requirements

Review pre-market and post-market surveillance data

Evaluate compliance with clinical performance studies and validation protocols

3. Quality Management System Evaluation

Assess the effectiveness of the Quality Management System (QMS)

Review documentation of quality policies, procedures, and records

Evaluate the risk management process (ISO 14971)

Examine the handling of non-conformities and corrective actions

4. Design and Development Review

Evaluate the design control processes, including design input, output, and verification

Review documentation of design changes and impact assessments

Assess usability engineering processes and user feedback incorporation

Verify compliance with design transfer and production processes

5. Manufacturing and Control Processes

Conduct walkthroughs of the manufacturing environment and processes

Assess controls related to equipment calibration and maintenance

Evaluate raw material and component sourcing and verification

Review batch production records for accuracy and completeness

6. Product Performance and Vigilance

Analyze post-market performance data and adverse event reports

Review processes for handling complaints and feedback

Assess monitoring of product stability and shelf life

Evaluate the effectiveness of corrective and preventive actions (CAPA)

7. Training and Competence

Verify training records for personnel involved in production and quality assurance

Assess the effectiveness of training programs related to regulatory compliance

Review competency assessments and ongoing professional development opportunities

Evaluate the communication of updates to procedures and regulations

8. Reporting and Documentation

Compile audit findings, observations, and areas for improvement

Develop actionable recommendations based on audit results

Prepare a comprehensive audit report for management review

Schedule a debrief meeting with stakeholders to discuss findings

9. Follow-Up Actions

Establish timelines for implementing corrective actions

Monitor progress on the implementation of recommendations

Schedule follow-up audits to verify compliance and effectiveness of actions taken

Document lessons learned and incorporate into future audit planning

Download CSV Download JSON Download Markdown

Use in Manifestly

Related Checklists

Inventory Management

Inventory Management is essential for monitoring and controlling the stock levels of materials and products in order to optimise production, reduce costs, and improve customer service.

view →

Shipping and Receiving Checklist

A Shipping and Receiving Checklist is important to ensure accuracy, quality control, and timely delivery of products.

view →

Employee Termination

Employee termination is important for maintaining a workplace environment that is safe, productive, and free from disruption.

view →

Regulatory Compliance

Regulatory compliance is essential for ensuring that manufacturers produce safe products that meet industry and government standards.

view →

Production Planning

Production Planning is essential for optimizing resources and ensuring efficient production of goods and services.

view →

Equipment Maintenance Checklist

Equipment Maintenance Checklist helps to ensure that manufacturing equipment is properly maintained and operating at optimal levels for maximum efficiency and productivity.

view →

Employee Onboarding

Employee Onboarding is essential to ensure that new hires are quickly integrated into the organization and enabled to become productive contributors to the team.

view →

Performance Evaluation Checklist

Performance Evaluation Checklists help to ensure that all manufacturing processes are running efficiently and effectively, and that any potential issues are identified and addressed quickly.

view →

Quality Assurance

Quality Assurance ensures that products and services meet customer standards and expectations.

view →

Environmental Compliance

Environmental Compliance ensures that the manufacturing process does not harm the environment or put the health and safety of employees and communities at risk.

view →

Workplace Safety Checklist

A Workplace Safety Checklist is an essential tool for ensuring a safe and productive work environment for employees.

view →

Employee Training Checklist

Employee Training Checklists are important tools to ensure employees are properly trained in safety, quality and job-specific skills.

view →

Hey there! Here's a little about us or visit our recurring workflow SaaS: Manifestly Checklists

Light Dark