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ISO 9001 calibration audit checklist template

ISO 9001 calibration audit checklist template

Keep your calibration processes accurate and audit-ready with this checklist. You can track equipment status, review calibration methods, and manage nonconforming items.

Use this template
or download pdf
ISO 9001 calibration audit checklist template

Keep your calibration processes accurate and audit-ready with this checklist. You can track equipment status, review calibration methods, and manage nonconforming items.

Use this template
or download pdf

About the ISO 9001 calibration audit checklist template

When devices don’t have proper calibration, it can quietly undermine product quality and compliance long before it gets noticed. The ISO 9001 calibration audit checklist helps you standardize your audit process, making it easier to identify gaps, manage calibration records, and stay aligned with ISO requirements. It’s easily customizable too, so using it saves you time and keeps your audits consistent across teams.

Contents of the ISO 9001 calibration audit checklist

Here are the key elements that make this template a powerful tool for streamlining your audits:

  1. Calibration program overview: This section outlines whether there’s a documented calibration program in place. It helps you confirm that you’ve covered all critical equipment, defined procedures clearly, and justified calibration intervals.
  2. Calibration methods: Here, you’ll verify that methods are appropriate, validated, and traceable to national or international standards. It also ensures you’ve controlled environmental conditions and considered measurement uncertainties, which are crucial for reliable results.
  3. Calibration equipment management: This part focuses on how you identify, maintain, and protect equipment and standards from damage or unauthorized adjustments.
  4. Handling nonconforming equipment: You’ll assess processes for identifying and managing out-of-calibration equipment. This includes corrective actions and how to review previous measurement results for accuracy.
  5. Calibration records: Next, this section ensures proper documentation of calibration activities, from dates and results to personnel involved. This way, records are easy to retrieve during audits and reviews.
  6. Continuous improvement measures: Finally, this section tracks how you review, audit, and improve your calibration program over time, supporting ISO 9001’s focus on ongoing quality enhancement.

When to use the ISO 9001 calibration audit checklist

Using an ISO 9001 calibration audit checklist is a powerful tool for maintaining accuracy and compliance. It’s most effective during scheduled internal audits to verify that your calibration processes meet ISO 9001 standards. You’ll also find it invaluable when onboarding new equipment, after significant process changes, or if there’s been a nonconformity related to measurement accuracy.

If you manage quality assurance, this checklist helps you maintain consistency across audits, pinpoint gaps early, and keep calibration records audit-ready. It’s also a smart tool for routine checks so your team follows standardized procedures every time.

Boost accuracy and reliability with Lumiform’s tools

Stay ahead of compliance issues by using a checklist designed to keep your calibration process sharp and consistent. With clear sections for tracking equipment status, calibration methods, and nonconformities, you’ll spot issues faster and keep records organized. Whether you’re managing routine audits or diving into complex quality checks, this template keeps your team aligned while improving data accuracy.

Related categories

  • Quality management templates
  • General templates
  • ISO templates
  • Quality assurance templates
Preview of the template
Page 1
Calibration Program
Is there a documented calibration program in place?
Does the calibration program cover all equipment requiring calibration?
Are calibration procedures documented and implemented?
Are calibration intervals defined and justified?
Are calibration records maintained and readily available?
Are calibration status labels or tags used to indicate calibration status?
Calibration Methods
Are calibration methods appropriate for the intended use of the equipment?
Are calibration methods traceable to national or international standards?
Are calibration methods validated for their intended use?
Are environmental conditions considered and controlled during calibration?
Are measurement uncertainties calculated and considered for calibration results?
Are calibration results reviewed and approved by authorized personnel?
Calibration Equipment
Are calibration standards and equipment properly identified, controlled, and maintained?
Are calibration standards and equipment properly handled, transported, and stored?
Are calibration standards and equipment properly verified before use?
Are calibration standards and equipment protected from damage, deterioration, and misuse?
Are calibration standards and equipment properly safeguarded against adjustments that would invalidate the calibration?
Nonconforming Equipment
Is there a process for identifying and managing nonconforming equipment?
Are appropriate actions taken when equipment is found to be out of calibration?
Are records maintained for nonconforming equipment, including actions taken?
Are there procedures to recall and review the validity of previous measurement results when equipment is found to be out of calibration?
Are there procedures to prevent the use of nonconforming equipment?
Calibration Records
Are calibration records maintained, including the equipment, date, results, and personnel involved?
Are calibration records reviewed and approved by authorized personnel?
Are calibration records retained for the appropriate duration?
Are calibration records readily available for review and audit?
Are there procedures in place to protect calibration records from unauthorized access, damage, or loss?
Continuous Improvement
Are there procedures in place to review the calibration program and identify opportunities for improvement?
Are corrective and preventive actions taken to address issues identified in the calibration program?
Are personnel involved in the calibration program trained and competent?
Is the calibration program periodically audited for compliance and effectiveness?
Are lessons learned and best practices shared to improve the calibration program?

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

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Frequently asked questions

What is the purpose of an ISO 9001 calibration audit?

An ISO 9001 calibration audit is meant to verify if all measuring equipment in quality-critical processes are accurate, reliable, and maintained according to defined standards. This audit checks if calibration procedures are properly documented, traceable to national or international standards, and consistently applied to support product quality and regulatory compliance.

What types of equipment require calibration under ISO 9001?

Any equipment that affects the quality of products or services requires calibration under ISO 9001. This includes measuring tools like micrometers, pressure gauges, thermometers, multimeters, scales, and even software-based measurement systems. If a device affects the accuracy of measurements used for quality decisions, it should be part of the calibration program.

Who is responsible for managing calibration audits in a company?

Typically, the quality management team oversees calibration audits, often led by a quality assurance manager or calibration coordinator. However, responsibility can vary depending on the company’s structure. In some cases, specific departments manage their own equipment, but ultimate accountability lies with leadership to maintain ISO 9001 compliance.


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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