ISO Accreditation: Does My Lab Need It?

ISO Accreditation: Does My Lab Need It? | LabLynx Resources

What You Need and How to Get It

Across industries, ISO accreditation is becoming a must-have for testing laboratories. This proof of competence reassures customers that your lab has the discipline and systems to produce consistently valid results. At the same time, ISO accreditation boosts your lab’s productivity. Yet the only quick, affordable way for a laboratory to achieve ISO accreditation is to have a laboratory information management system (LIMS). Here’s what you need to know about ISO accreditation and how a LIMS makes all the difference.

Benefits of ISO Accreditations

Standards are guidelines for best practices that produce consistent results. But a standard is not a standard if everyone has their own version. This is why the national standards organizations in 165 countries work together within the International Organization for Standardization. ISO committees distill expert opinions on best practices across many fields and industries.

For laboratories, the main standards of interest are created by ISO’s Committee on Conformity Assessment (CASCO). Many of its standards focus on the accreditation process, but there is one that applies universally to all testing laboratories:

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

Receiving an accreditation to ISO/IEC 17025 shows your customers, regulators and the public that your lab has the systems in place to produce consistently valid test results. Another standard, ISO/IEC 17020:2012, applies to those laboratories that conduct inspection activities. ISO also develops testing standards that define best practices for specific industries. Some other main ISO standards that can apply to laboratories include:

  • ISO 15189:2012 Medical Laboratories – Given the healthcare system’s unique requirements the ISO adapted ISO/IEC 17025 to include elements specific to medical testing laboratories. For example, laboratories must consider the appropriateness of test requests in order to avoid negative patient outcomes.
  • ISO 17034:2016 General Requirements For The Competence Of Reference Material Producers – For business who provide reference materials/standards for other labs to use in QC testing, their laboratories must ensure consistent products that meet the stringent specifications that other samples are measured against.
  • ISO 14000 Environmental Management: These standards help organizations develop systems to measure and improve their environmental impacts. In particular, the ISO 14000 standards guide organizations trying to reduce their greenhouse gas emissions.
  • ISO/TS 20224-6:2020 Molecular Biomarker Analysis: ISO standards can dive deep into specific applications. ISO/TS 20224-6 specifies how food processors use real-time PCR testing to detect the presence of horse DNA. Similar ISO specifications are available in aerospace, textiles, mining and other industries.
  • ISO 9001:2015 Quality Management Systems – Labs, like any other business, may need to guarantee their processes and practices (SOPs: standard operating procedures) in order to instill confidence in their professionalism. Or they may need to meet these standards as part of a larger organization. And laboratory information management systems can be the storehouse of these individual SOPs and the Quality Manual itself, and even facilitate or ensure they are followed by incorporating them into workflows.

There are literally hundreds of ISO standards governing very specific products and processes, which may or may not come into play for your lab.

Does ISO Accreditation Matter?

ISO standards are voluntary and getting accredited can be both expensive and time-consuming. Unless your laboratory’s customers or regulators require it, going all the way through the accreditation process may not be necessary. But it could be in your organization’s best interest to use a standard like ISO/IEC 17025 even if you skip the accreditation process.

ISO/IEC 17025 improves a laboratory’s performance and efficiency by institutionalizing best practices and operational excellence. Creating, documenting and enforcing standard workflows reduces the errors and manual processes that sap your lab’s productivity. Staff can spend more time conducting tests and other value-added activities when they are not bogged down re-doing tests.

Accreditation to ISO standards supports your laboratory’s business. Given the difficulties involved, ISO accreditation provides significant competitive advantages. Potential customers may prefer dealing with ISO-accredited laboratories, especially if they themselves are ISO-compliant.

If you operate or plan to operate in a regulated industry, then ISO accreditation may not be optional. Regulators often require ISO 17025 accreditation, directly or indirectly, as part of their licensing process. California and other states, for example, require ISO 17025 accreditation when licensing cannabis testing laboratories. Many federal and state agencies require National Environmental Laboratory Accreditation Program accreditation which is modeled after ISO 17025.

The Role of LIMS in ISO Accreditation and Compliance

A laboratory information management system (LIMS) simplifies the accreditation process and makes post-accreditation audits less painful.

The LIMS does more than document your lab’s standard operating procedures. By configuring the methods and workflows for each testing process into your LIMS, you ensure that the standard process is the only one that your staff follows.

ISO 17025 requires laboratories to ensure their employees are qualified to perform the tests they conduct. A LIMS records employee credentials and certifications and tracks their training progress. The scheduling system can prevent employees from being assigned to tests they are not qualified to conduct.

Accredited laboratories must monitor the condition of their instruments as well as the conditions under which they perform tests. The LIMS collects maintenance schedules, instrument calibration records, temperature data and other information into a central repository.

To keep their accreditation, labs must have independent auditors review their quality management processes. These audits are much less painful when you have a LIMS. All of the data that auditors require are stored in the LIMS: SOPs, employee certifications, instrument calibrations and more.

Agile Laboratories Rely on LabLynx LIMS for ISO Accreditation

Building your operations around ISO 17025 and other standards does not mean you are binding your laboratory to rigid, inflexible processes. The business of laboratory testing is too dynamic for that to be sustainable. Laboratories must be responsive to new science, changing customer requirements and evolving regulations. LabLynx LIMS solutions help make laboratories agile while providing the structured systems needed for ISO accreditation.

Configurability: You do not need expensive development work to configure new methods and workflows in your LabLynx LIMS. The easy user interface lets laboratory administrators configure the new workflow along with SOPs and other relevant documentation.

Instrument Integration and Sample Management: End-to-end digitization eliminates all of the inefficiencies your paper or spreadsheet processes generated. Your LabLynx LIMS will track samples from registration to disposal. Integration capabilities avoid transcription errors by sending test data straight from the instruments to the LIMS.

Secure Cloud Accessibility: As a central repository for your lab’s data, the LabLynx LIMS’ secure, cloud database gives your staff anywhere, anytime access to the information they need. Web portals let you extend that access to customers so they can track the progress of their tests and get quick access to results.

If ISO accreditation is in your lab’s future, or even improving processes to meet standards without seeking accreditation, LabLynx can help you build a solid foundation. As part of the implementation process, our in-house experts will help configure your LabLynx LIMS to support accreditation to ISO 17025 or other relevant standards. Find out more by contacting LabLynx’ at [email protected] or 866-LABLYNX (522-5969) for more information.

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