Why ISO Calibration Is Essential to Your Laboratory’s Integrity

ISO Requirements for Calibration

A hard truth of laboratory work is that proving the accuracy of your work is no easy task. If you don’t have the right measures in place to back up and substantiate your team’s efforts, no matter their expertise or education, your lab’s results will never be safe from scrutiny.

As Greg Freitag, Director of Sales Operations at Qualer explains, “Too many labs don’t pay close enough attention to their equipment’s calibration processes – this unfortunately leaves the integrity of their data up for speculation by many respected industry leaders. Following ISO calibration standards can help prevent their work from being questioned.”

To avoid the nightmare of discarding reams of results due to poor equipment maintenance, it’s crucial your lab consistently meets the necessary ISO calibration standards for your laboratory equipment. 

However, ISO standards are complex. it’s not always obvious what ISO standards to adhere to and which of your equipment must comply. In this article we hope to help you make sense of ISO calibration standards and how to 

What Is An ISO Calibration Standard?

Let’s begin with the basics. An ISO calibration standard is the guidelines developed by the International Organization for Standardization (ISO) that outlines industry-accepted calibration practices for a piece of equipment. ISO creates trusted standards that are recognized around the world as best practices to follow when calibrating mission-critical equipment.

They create consistency for monitoring and measuring practices across industries. Adherence to an ISO standard is often required for a laboratory to prove their work is accurate and of a high standard, to do work for certain customers, certain product certifications.

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Why Are ISO Requirements for Calibration So Important to a Laboratory?

Laboratories are a place where answers are given and truths are found. Your lab’s results can have significant implications for the people, products, or manufacturing processes they pertain to. Being able to demonstrate the numbers you provide are accurate and trustworthy is critical and following ISO calibration standards helps you to do just that.

Other reasons laboratories should adhere to ISO calibration standards include:

  • Meet Regulatory Compliance Requirements: ISO standards are often required in a lab in order to meet certain regulatory, contractual, or legal requirements.
  • Financial Efficiency: Streamlined calibration processes reduce operational costs and improve resource management. Meeting ISO standards also increases a laboratory’s prospective client base.
  • Safety Assurance: Ensure your equipment operates safely, and reduces accident risks in the laboratory or organization.
  • Reputation: ISO standards help enhance your lab’s credibility and give your company a better competitive advantage.
  • Quality Guarantee: With ISO standards assurance, your data will be more readily trusted by customers, vendors, and accreditation bodies.

Types of ISO Standards for Laboratories

There are more than 24,000 standards in the ISO database. Some pertain to quality control practices, and others impact documentation policies, vendor selection processes and more. Knowing which one to follow and comply with when it comes to your lab equipment calibration program isn’t always obvious.

Below is an explanation of the different ISO standards affecting equipment calibration that lab managers need to know.

ISO 17025: General Requirements for the Competence of Testing and Calibration Laboratories

This is a fundamental standard for labs. This standard is designed to promote confidence in the operation of laboratories by outlining stringent requirements for their calibration and testing processes.

Key requirements of ISO 17025 include:

  • Utilization of a quality management system
  • Implementation of sound, validated calibration methods
  • Rigorous personnel training
  • Thorough record-keeping and documentation

ISO 17025 ensures labs provide valid, reliable, and consistent results, enabling trust and credibility in the data they produce. Adhering to this standard, laboratories can affirm their commitment to high-quality operations and accurate results.

ISO 13485: Calibration Requirements for Medical Devices

ISO 13485 is a standard that represents the requirements for a comprehensive Quality Management System (QMS) for the design and manufacture of medical devices. It is integral to laboratories calibrating medical equipment.

For labs calibrating medical devices, compliance with ISO 13485 is crucial. This standard ensures devices are reliable and meet the regulatory requirements, thereby safeguarding patient health and safety.

The role of calibration in ISO 13485 is paramount. By verifying the accuracy and precision of medical devices, calibration underpins regulatory compliance, promotes device efficacy, and contributes to better patient outcomes. Adhering to ISO 13485 helps ensure the trustworthiness and reliability of calibrated medical devices.

ISO 9001: Quality Management Systems

ISO 9001, the international standard for Quality Management Systems (QMS), sets out criteria for a QMS, promoting a process-oriented approach to managing an organization’s activities.

It has a pivotal role in calibration practices. 

ISO 9001 emphasizes the monitoring and maintenance of resources, including equipment, to ensure consistent quality. The standard includes the regular calibration of lab equipment, such as ISO 9001 calibration frequency parameters, to ensure their accuracy and precision and includes to follow

By integrating calibration into a broader QMS, labs can ensure their testing and measurement capabilities are not compromised, leading to better quality control, improved efficiency, and increased confidence in the validity of lab results.

ISO 8655: Pipette Calibration and Testing of Piston-Operated Volumetric Apparatus

ISO Calibration Standard

ISO 8655 is the international standard related to the calibration and testing of tools used to manually handle liquids that are also piston-operated. In more simple terms, ISO8655 is the set of rules labs need to follow when calibrating and testing the following tools:

  • Pipettes
  • Burettes
  • Diluters
  • Liquid dispensers
  • Syringes

Without properly functioning measuring tools, a lab simply cannot produce reliable, meaningful test results. Additionally, in order to prove to an auditor, client, or colleague that your results are accurate and of good quality, you need to be able to demonstrate your measuring tools were in compliance at the time your team generated those results.

By following ISO 8655 to the letter, laboratories can keep their measuring tools functioning properly. It also helps to ensure their facility maintains alignment with other compliance requirements (such as ISO 17025) that are essential to their operations, quality assurance program, and contractual obligations.

Learn more about effective calibration practices and solutions from the Qualer blog:

Tips to Run an Effective ISO Calibration Program

Understand the ISO Standards 

The first step towards running an effective calibration program is to fully comprehend the ISO standards that apply to your laboratory. This involves identifying relevant standards, interpreting their requirements, and aligning them with your lab’s specific needs. Not all ISO standards may apply to your lab, so careful consideration is crucial.

Developing an ISO-Compliant Calibration Process 

Creating a calibration process that meets ISO standards is no small task. Here are some steps to help guide the process:

  • Schedule regular calibration checks to maintain equipment accuracy.
  • Use certified reference materials to ensure reliable calibration results.
  • Document all calibration activities and results for transparency and traceability.
  • Regularly train personnel on proper calibration techniques and changes in relevant standards.

Each of the above steps can be made easier by Incorporating calibration management software into your laboratory practices. It will also help reduce measurement uncertainty, missed calibration services, and generate ISO calibration certifications more easily. Additionally, it can give everyone at your organization a view into your equipment’s calibration statuses.

Ongoing Compliance and Improvement 

An effective ISO calibration program doesn’t end with the development of procedures. Continuous monitoring and improvement are crucial for ongoing compliance—this gives your data the backbone and measurement traceability it needs to truly showcase your team’s expertise. 

Ongoing measures involve regular auditing of calibration processes, prompt addressing of any identified issues, and keeping up to date with changes in ISO standards. Software that tracks standard updates, equipment maintenance records, manufacturer recommendations can be incorporated into your daily calibration processes and make your life much easier.

Build Better Calibration Practices. Work with Qualer

At Qualer, we’re committed to helping laboratories get the most out of their vital assets. We provide Computerized Maintenance Management Solutions (CMMS) that are uniquely tailored to the needs of laboratories.

We have years of experience giving laboratories the tools they need to keep their facilities on-point and perfectly maintained at all times. 

To learn what we can help your lab achieve, contact us today.

Frequently Asked Questions

ISO calibration follows International Organization for Standardization guidelines, focusing on technical accuracy, methods, and documentation for consistent measurement results. It’s about precision and traceability in various industries.

cGMP calibration, under Current Good Manufacturing Practices, is broader, encompassing not just measurement accuracy but also quality control aspects like equipment maintenance and record-keeping, especially in pharmaceutical and medical sectors.

It ensures products are consistently produced to quality standards, mandated by regulatory bodies like the FDA.

It’s not uncommon for a laboratory to need to adhere to both ISO standards as well as cGMP ones.

Maintaining compliance with multiple ISO standards requires careful documentation and tracking of multiple assets, calibration and maintenance tasks, and asset health.

A CMMS designed for large-scale laboratories can help streamline and simplify ISO compliance management. For instance, Qualer’s CMMS for lab facilities enables teams to track and manage each asset that falls under ISO compliance requirements.

The Qualer CMMS aids in better ISO management, regardless of the standard being adhered to with the following features:

  • Automate scheduling of maintenance and calibration tasks
  • Be a centralized hub for all ISO calibration standards and certificates of conformity 
  • Track asset managers
  • Integrate with other ISO essential software systems, such as LIMS

Best practices for documenting ISO 17025 calibration processes include maintaining detailed records of calibration procedures, results, and equipment used.

It’s crucial to ensure traceability by recording calibration dates, personnel involved, and reference standards.

Additionally, regularly reviewing and updating documentation procedures to align with ISO 17025 requirements is essential.

Implementing a system like Qualer’s CMMS can be beneficial, as it offers comprehensive record-keeping capabilities, the accuracy and ease of access to calibration records, thereby supporting compliance and efficiency in laboratory operations.

Software solutions play a crucial role in managing ISO standards for laboratory teams.

Key solutions include:

  • CMMS (Computerized Maintenance Management System): Streamlines equipment maintenance and calibration schedules, ensuring compliance with ISO standards.
  • LIMS (Laboratory Information Management System): Manages laboratory workflows, data, and assay results.
  • Quality Management Software: Provides tools for process control, document management, and quality assurance.

These systems, particularly CMMS, help lab teams maintain ISO compliance efficiently. They automate tracking, scheduling, and reporting, reducing errors and enhancing overall laboratory management and operational reliability.

To align calibration processes with ISO 13485 calibration requirements:

  • Understand and Implement Standards: Gain a thorough understanding of ISO 13485 requirements and integrate them into the laboratory’s calibration procedures.
  • Regular Training and Documentation: Ensure staff are regularly trained on these standards and maintain detailed documentation of all calibration activities for compliance and traceability.
  • Continuous Review and Improvement: Regularly review and update calibration processes to adhere to ISO 13485, and implement continuous improvement practices to maintain compliance and enhance quality.

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