ISO 9001 Internal Audit Checklist – Download Free PDF

ISO 9001 internal audit checklist template

Our ISO 9001 internal audit checklist is designed to help you efficiently assess your organization’s compliance with ISO 9001 quality management standards. Tailored for industries like manufacturing, logistics, and healthcare, this template ensures you meet regulatory requirements while identifying non-conformities in your processes. According to the International Organization for Standardization (ISO), over 1.2 million organizations worldwide are certified to ISO 9001, underscoring the global demand for thorough quality management systems.

This template simplifies internal audits by providing a step-by-step guide to evaluate quality procedures, document findings, and assign corrective actions. It’s ideal for multi-site operations needing consistent reporting and compliance management. For related needs, explore our ISO 14001 or ISO 27001 internal audit checklists to address environmental or information security standards.

Related categories

Preview of the template

Quality Management System

Does the organization have a documented quality management system?

Does the quality management system address the requirements of ISO 9001?

Is the quality management system effectively implemented and maintained?

Are quality objectives established?

Are quality objectives measurable and consistent with the quality policy?

Management Responsibility

Is top management committed to the development and implementation of the quality management system?

Has a quality policy been established and communicated?

Have roles, responsibilities, and authorities been defined and communicated within the organization?

Resource Management

Are resources, including infrastructure and work environment, adequate to achieve quality objectives?

Are personnel with appropriate competence, education, training, skills, and experience identified and provided?

Is the work environment managed to ensure conformity of product?

Product Realization

Are processes for product realization, including planning, customer-related processes, and design and development, established and implemented?

Are purchasing processes, including evaluation of suppliers, established and implemented?

Are production and service provision processes, including identification and traceability, controlled?

Are customer property and product preservation processes established and implemented?

Measurement, Analysis, and Improvement

Are processes for measurement, analysis, and improvement established and implemented?

Are internal audits conducted to verify the effectiveness of the quality management system?

Are corrective and preventive actions taken to address nonconformities?

Is the quality management system continually improved?

Frequently asked questions

What is the purpose of an ISO 9001 internal audit?

An ISO 9001 internal audit ensures your organization’s quality management system (QMS) complies with ISO 9001 standards. It identifies process gaps, non-conformities, and improvement opportunities, helping you maintain certification and improve efficiency. Regular audits also prepare your business for external audits and reduce compliance risks.

What are the key steps in an ISO 9001 internal audit?

Key steps include planning the audit, reviewing ISO 9001 requirements, creating an audit checklist, conducting interviews and inspections, documenting findings, and preparing a report. Finally, assign corrective actions to address non-conformities. An organized approach ensures thoroughness and consistency across all departments.

What are common non-conformities found in iso 9001 audits?

Frequent non-conformities include incomplete documentation, lack of employee training, inadequate process monitoring, and failure to address customer complaints effectively. Other issues might involve missing records of corrective actions or deviations from documented procedures. Addressing these gaps promptly is critical to maintaining ISO 9001 certification.

How do you prepare for an ISO 9001 internal audit?

Preparation involves scheduling the audit, notifying relevant teams, reviewing ISO 9001 requirements, and creating a detailed audit checklist. Make sure all necessary documents are accessible, and train staff to understand the purpose and process of the audit to reduce resistance or confusion.

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.