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ISO 9000 requirements checklist

ISO 9000 requirements checklist

Review and document compliance with the standard’s key requirements using this checklist. It outlines essential criteria for quality management systems so you can identify gaps.

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ISO 9000 requirements checklist

Review and document compliance with the standard’s key requirements using this checklist. It outlines essential criteria for quality management systems so you can identify gaps.

Use this template with Lumiform

  • Customize this template or build your own
  • Fill out templates via mobile app
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

An ISO 9000 requirements checklist helps you stay organized and ensures your team covers all critical compliance points. It covers essential elements from system documentation to continuous improvement processes.

Research indicates organizations implementing ISO 9000 standards work more efficiently as their processes become better aligned and understood by everyone, increasing productivity and reducing internal costs. For example, when conducting internal audits, this checklist allows you to verify that management reviews are occurring at planned intervals and that corrective actions are properly documented and implemented.

Related categories

  • Quality management templates
  • Risk management and compliance templates
  • General templates
  • ISO templates

Created by

Author Name Inioluwa Ademuwagun
Preview of the template
Entity
Quality Management System
Is there a documented quality management system that meets the requirements of ISO 9001?
Is the scope of the quality management system clearly defined?
Are all the necessary procedures, processes and resources identified and provided?
Management Responsibility
Is top management committed to the development and implementation of the quality management system and continually improving its effectiveness?
Are quality objectives established at relevant functions and levels within the organization?
Is management review conducted at planned intervals to ensure the continuing suitability, adequacy and effectiveness of the quality management system?
Resource Management
Are the resources needed to implement and maintain the quality management system and continually improve its effectiveness, identified and provided?
Is personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experience?
Is the infrastructure (e.g. building, workspace, process equipment, supporting services) needed to achieve conformity to product requirements provided and maintained?
Product Realization
Are planning activities conducted to ensure the effective operation of the quality management system?
Are processes for design and development, purchasing, production and service provision, identification and traceability, customer property, and preservation of product established, implemented and maintained?
Is monitoring and measurement equipment calibrated or verified at specified intervals or prior to use?
Measurement, Analysis and Improvement
Are processes needed to monitor, measure, analyze and improve the quality management system established, implemented and maintained?
Are internal audits conducted at planned intervals to determine the effectiveness of the quality management system?
Are corrective and preventive actions taken to eliminate the causes of actual or potential nonconformities?

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Frequently asked questions

How do I address requirements that partially meet ISO 9000 standards?

Document the specific aspects that meet requirements and those that don’t, rather than simply marking “no.” Create action plans that build upon existing strengths while addressing gaps. This approach recognizes progress already made and focuses improvement efforts on specific deficiencies rather than implementing completely new processes.

What’s the difference between corrective and preventive actions?

Corrective actions address existing non-conformities identified during your audit, while preventive actions target potential issues before they occur. Both are evaluated in the measurement section of the checklist. Effective quality management systems balance these approaches—fixing current problems while proactively preventing future ones based on trend analysis and risk assessment.

What should I do if we have several “no” responses on the checklist?

View these as valuable improvement opportunities rather than failures. For each “no” response, document the specific gap, assign responsibility for resolution, establish a realistic timeline, and implement a verification process to confirm the fix. This turns compliance challenges into strategic quality improvements that strengthen your management system.

Author
Inioluwa Ademuwagun
Inioluwa is a freelance content writer with a passion for words and everything marketing. She has worked closely with B2B SaaS and e-commerce brands creating product-led content. She loves to read fiction and would describe herself as an introverted nerd who desires to travel around the world. She currently doing that with her words till she can with her eyes
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.
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