ISO 17025 in Canada

Why ISO 17025 matters?

Because of differences in personnel expertise, equipment, and Standard Operating Procedures, testing laboratories can produce different results for the same sample. Uncalibrated or poorly maintained instruments, laboratory conditions, and the competence of the people running a test all contribute to these discrepancies – which in turn affect the decisions made on the results. So what can a testing laboratory do to assure quality and safety?

One answer is ISO 17025, which sets out requirements for testing and calibration laboratories. To demonstrate their technical competence and the accuracy of their results, laboratories obtain ISO 17025 accreditation. This article looks at why that matters.

About ISO/IEC 17025

ISO/IEC 17025:2017 sets the general requirements for the competence, impartiality, and consistent operation of laboratories. It defines what laboratory operations must include to build confidence in the lab’s ability to produce valid, consistent testing, calibration, and sampling results. It was developed jointly by ISO and the International Electrotechnical Commission (IEC). By helping to harmonize procedures and techniques, ISO 17025 supports international acceptance of results and cooperation between laboratories and other bodies.

Which organizations need ISO 17025?

ISO 17025 applies to all laboratories, regardless of size or the scope of their testing and calibration methods. Laboratories use it to establish their quality, safety, and technical-operations management systems and to improve the consistency of producing valid results.

How to prepare your lab for ISO 17025?

ISO 17025 requires a laboratory to design and implement actions to address risks and opportunities. Doing so lays the groundwork for improving the management system’s performance, achieving better results, and avoiding undesirable outcomes – and it is the laboratory’s responsibility to evaluate which risks and opportunities to address. Conforming to ISO 17025 also makes it easier for laboratories to collaborate, share experience, and compare results across borders.

The importance of ISO 17025

ISO 17025 helps laboratories maintain technical competence and produce accurate results. By supporting ongoing compliance with relevant requirements, it builds confidence in the laboratory, its data, and its services. It sets out what a laboratory must demonstrate to show it can deliver accurate results and operate properly. Laboratories that meet ISO 17025 will also align with many ISO 9001 principles.

The structure of ISO 17025

ISO/IEC 17025:2017 organizes its requirements into five main areas:

• General requirements (impartiality and confidentiality)
• Structural requirements
• Resource requirements (personnel, facilities, equipment)
• Process requirements (the core testing and calibration activities)
• Management system requirements

The ISO 17025 standard is designed to be used alongside other relevant industry standards, and it does not claim to cover every requirement for laboratory operation – where specific needs arise, other standards may also apply. Its flexible framework allows it to be used in combination with other standards.  

Requirements for ISO 17025 accreditation

Before seeking ISO 17025 accreditation, a laboratory generally needs to put the following in place:

• Management system documentation
• Document control
• Records management
• Actions to address risks and opportunities
• Improvement processes
• Corrective actions
• Ongoing internal audits
• Management reviews

Once these are in place, the laboratory applies to an accreditation body, which evaluates the documentation and conducts on-site assessments to confirm ISO 17025 is effectively implemented. After any non-conformities are resolved, the accreditation body grants ISO 17025 accreditation.

Benefits of ISO 17025 accreditation

• Improves the laboratory’s ability to produce reliable results
• Establishes technical competence in the event of a dispute or legitimacy challenge
• Provides a competitive advantage and increased market share
• Improves efficiency and reduces operational costs
• Builds a proactive, risk-based quality culture rather than a reactive one
• Increases customer trust and reduces complaints

Contact IAS today to learn more about ISO 17025, or visit our frequently asked questions page.

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