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Quality system audit checklist

Quality system audit checklist

Perform comprehensive audits of your Quality Management System with ease using this customizable checklist. Use it to track documentation, resource management, and compliance across all departments.

Use this template
or download pdf
Quality system audit checklist

Perform comprehensive audits of your Quality Management System with ease using this customizable checklist. Use it to track documentation, resource management, and compliance across all departments.

Use this template
or download pdf

About the Quality system audit checklist

ity audits play a vital role in ensuring that all processes in your organization align with regulatory and industry standards. Our quality system audit checklist is designed to help you conduct thorough, consistent evaluations of your Quality Management System (QMS). Whether you’re auditing documentation, employee awareness, or resource management, this template simplifies the process. With this easy-to-use template, you can efficiently monitor and record the performance of your QMS. Use the checklist to identify gaps, implement corrective actions, and continuously improve your operations, helping your business achieve higher standards and sustained quality.

Key elements of the quality system audit checklist

The quality system audit checklist covers key aspects of a comprehensive quality management system that should be thoroughly evaluated:
  1. Quality management system: The first section verifies if a documented QMS is in place and whether it covers all relevant processes. You’ll ensure that your system is effectively implemented and communicated across the organization, which is critical for meeting quality objectives.
  2. Documentation and records: Proper documentation is crucial to any QMS. This part of the checklist assesses whether all necessary documents are controlled, stored securely, and up-to-date.
  3. Management responsibility: You’ll assess whether leadership is fully committed to the QMS, including setting quality policies. Management reviews should be conducted regularly to ensure the QMS’s suitability and effectiveness.
  4. Resource management: This section looks at the adequacy of resources, including personnel, infrastructure, and equipment. You’ll check if employees are properly trained and whether the working environment is conducive to achieving quality outcomes.
  5. Product/service realization: Make sure that customer requirements are clearly defined and that processes for design, procurement, and production are planned and controlled.
  6. Measurement, analysis, and improvement: This final section helps you monitor the effectiveness of your QMS through internal audits, corrective and preventive actions, and customer feedback.

Best practices for using the quality system audit checklist

To get the most out of your checklist and improve your audit processes, follow these best practices. One important approach is to focus on high-risk areas first. By tackling these areas early, you prevent potential nonconformities from escalating and ensure that your resources are allocated efficiently to where they are needed most. It’s also critical to ensure auditor independence. If the auditor isn’t directly involved in the processes being reviewed, they can offer an impartial perspective, which leads to more accurate findings. This eliminates the risk of bias and ensures that the evaluation is objective. Aim to schedule audits at appropriate intervals too. Regular audits are key to maintaining continuous improvement in your organization. Instead of waiting for issues to arise, establish a proactive audit schedule that takes into account both regulatory requirements and the risk levels of your operations.

Start using Lumiform’s quality system audit checklist today

Streamline your audit process with our specialized checklist and make sure every detail is covered. Use this template to conduct thorough reviews of your quality management system, easily track nonconformities, and ensure consistency across all audits. With Lumiform’s tools, you can stay organized and efficient, even with complex, large-scale audits.

Categories

  • Quality management templates
  • General templates
  • Quality assurance templates
Preview of the template
Page 1
Quality Management System
Is there a documented quality management system in place?
Does the quality management system cover all relevant processes and activities?
Is the quality management system effectively implemented and maintained?
Are all employees aware of the quality management system and their roles?
Are quality objectives established, monitored and achieved?
Documentation and Records
Is there a document control procedure in place?
Are all necessary documents and records maintained and controlled?
Are documents and records legible, identifiable and retrievable?
Are obsolete documents promptly removed from use?
Are records stored in a way that prevents loss, damage or deterioration?
Management Responsibility
Is there a defined organizational structure with clear responsibilities?
Does top management demonstrate leadership and commitment to the quality management system?
Are quality policies and objectives established and communicated?
Are management reviews conducted periodically to ensure the QMS suitability, adequacy and effectiveness?
Are resources (human, infrastructure, work environment) adequately provided?
Resource Management
Are personnel competent based on appropriate education, training, skills and experience?
Are training needs identified and training provided?
Is the work environment suitable for achieving conformity of products/services?
Are infrastructure, facilities, equipment and tools adequate and properly maintained?
Are calibration and verification of measuring equipment performed as required?
Product/Service Realization
Are customer requirements clearly understood and documented?
Are design and development processes in place, controlled and verified?
Are purchasing processes effective in ensuring conformity of procured products/services?
Are production and service provision processes planned, implemented and controlled?
Are identification and traceability maintained throughout product realization?
Is customer property handled, stored and maintained properly?
Are preservation requirements for products understood and implemented?
Measurement, Analysis and Improvement
Are processes for monitoring, measurement, analysis and improvement planned and implemented?
Are internal audits conducted at planned intervals to evaluate the QMS?
Are nonconformities identified, documented and corrective actions taken?
Are preventive actions taken to eliminate the causes of potential nonconformities?
Is customer feedback and satisfaction data collected, analyzed and acted upon?
Is the overall effectiveness of the QMS regularly reviewed and improved?
This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.