Why ISO Calibration Is Critical for Life Science Laboratory Integrity

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.

"Too many labs don't pay close enough attention to their equipment's calibration processes,” explained industry expert Greg Freitag. “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 is crucial for a life science laboratory to consistently meet the necessary ISO calibration standards for laboratory equipment.

ISO standards are complex, however. It's not always obvious what ISO standards to adhere to and which of your equipment must comply. This article will help you make sense of ISO calibration and how to implement effective calibration management.

What Is an ISO Calibration Standard?

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

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

Why Is Life Science Calibration So Important to Your Laboratory?

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

Other reasons life science calibration practices should adhere to ISO standards include:

• Meet Regulatory Compliance Requirements: In a lab, ISO standards are commonly followed for the purpose of meeting certain regulatory, contractual, or legal requirements.
• Financial Efficiency: Streamlined calibration management processes reduce operational costs and improve resource management. Meeting ISO standards also increases a laboratory's prospective client base.
• Safety Assurance: Ensuring proper calibration gives peace of mind that your equipment operates safely and reduces accident risks in the laboratory or organization.
• Reputation: ISO calibration helps enhance your lab's credibility and gives your company an improved competitive advantage.
• Quality Guarantee: With the assurance of alignment with ISO standards, your data will be more readily trusted by customers, vendors, and accreditation bodies.

Types of ISO Standards for Life Science Calibration

As mentioned above, there are many types of ISO standards that impact life sciences companies. In fact, 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(s) 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 calibration management that lab managers in the life science industry 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 (QMS).
• Implementation of sound, validated calibration methods.
• Rigorous personnel training.
• Thorough record-keeping and documentation.

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

ISO 13485: Calibration Requirements for Medical Devices

ISO 13485 is a standard that represents the requirements for a comprehensive QMS for the design and manufacture of medical devices. It is integral to laboratories performing life science calibration of medical equipment.

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

Calibration plays a central role in ISO 13485. By verifying the accuracy and precision of medical devices, calibration management 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, outlines the 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.

By integrating life science calibration into the broader QMS, a lab 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 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, ISO 8655 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. Compliance with the standard also helps ensure that a facility is aligned with other compliance requirements (such as ISO 17025) that are essential to their operations, quality assurance program, and contractual obligations.

3 Tips to Run an Effective ISO Calibration Program

1. Understand the ISO Standards Pertinent to Your Lab

The first step for running an effective calibration management 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 calibration standards may apply to your lab, so careful consideration is crucial.

2. Develop an ISO-Compliant Calibration Process

Creating a life science 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 these steps can be made easier by incorporating purpose-built 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, calibration management software can give everyone at your organization a view into your equipment's calibration statuses.

3. Commit to Ongoing Compliance and Improvement

An effective ISO calibration program doesn't end with the development of procedures. Continuous monitoring and improvement are crucial for upholding consistent compliance—they give your data the backbone and measurement traceability needed 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. Calibration management software that tracks standard updates, equipment maintenance records, and manufacturer recommendations can be incorporated into your daily calibration processes and make your team’s work much easier.

Build Better Calibration Practices With MasterControl

At MasterControl, we're committed to helping laboratories get the most out of their vital assets. We provide specialized calibration management software that's uniquely tailored to the needs of companies that must meet life science calibration requirements.

We have years of experience giving laboratories the tools they need to keep their facilities on-point and perfectly maintained at all times. Our calibration management solutions ensure you stay ISO compliant while streamlining your calibration processes.

To learn what our calibration management software can do to help your lab, contact us today.