Quebec laboratories face a major challenge: Proving competence and reliability in testing and calibration. ISO/IEC 17025 accreditation is the international benchmark that demonstrates this competence. It serves as proof that a laboratory meets strict requirements for quality and reliability. What is ISO 17025? What are its benefits? Let’s take a closer look.
ISO 17025 is an essential standard for laboratories, helping them harmonize procedures and methods. This harmonization makes coordination between laboratories and other organizations easier.
A Brief History
Laboratory standardization began with the ISO/IEC Guide 25, published in 1990 through collaboration between the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). In 1999, the first ISO 17025 standard was released based on Guide 25, then revised in 2005 and 2017 to incorporate risk management and impartiality. The third edition, published in 2017, was reviewed and confirmed in 2023, meaning it remains current today.
What is ISO 17025?
The international standard ISO 17025:2017 defines general requirements for the competence of testing and calibration laboratories. It applies to all laboratories, regardless of size or sector. Its objectives include:
- Harmonizing methods and procedures
- Ensuring measurement traceability
- Strengthening confidence in reported results
ISO 17025:2017 is built on five main requirements that lead to laboratory accreditation. The figure below shows the details of each requirement.
These requirements align with ISO 9001, but ISO 17025 goes further by integrating technical competence management. A company or laboratory can be ISO 9001 certified without being ISO 17025 accredited.
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Quebec Context and Accreditation Bodies
In Quebec, ISO 17025 accreditation is particularly important for laboratories that must meet regulatory requirements in sectors such as environmental, agri-food, pharmaceutical, and industrial.
Key organizations involved include:
- Centre d’expertise en analyse environnementale du Québec (CEAEQ): Manages the Laboratory Accreditation Program (PALA) for environmental analyses.
- Standards Council of Canada (SCC): The national body that accredits according to ISO/IEC 17025.
- Some private laboratories are ISO 17025 accredited to provide services that comply with international standards.
What Are the Main Benefits?
Adopting ISO 17025 offers numerous advantages for laboratories and businesses alike.
First, it ensures international recognition, which facilitates exchanges and strengthens credibility with clients and partners, promoting loyalty and long-term agreements. Studies show that accreditation supports long-term growth and stability by enhancing reputation and regulatory compliance.
It also guarantees reliable results through strict requirements for method validation, traceability, and technical competence. Additionally, it helps meet regulatory obligations and expectations from Quebec authorities. ISO 17025-accredited laboratories report a significant reduction in errors and rework thanks to standardized processes and validated methods.
Beyond technical compliance, ISO 17025 fosters a culture of continuous improvement within the laboratory. By requiring training and accountability, the standard strengthens employee engagement and empowers teams to develop their skills. This dynamic boosts motivation, retention, and professional recognition. Accreditation also optimizes resources and improves operational efficiency, leading to measurable productivity gains.
Finally, when leadership actively participates in the process, achieving accreditation becomes a source of collective pride, reinforcing team cohesion and spirit.
How to Succeed in Your Accreditation Process?
To successfully achieve ISO 17025 accreditation, careful planning is essential, involving management and all teams. This planning should include a clear timeline and resource allocation, both financial and human. The accreditation process typically takes 6 to 18 months, depending on the laboratory’s size and complexity. Costs vary but generally include audit fees, training, and sometimes the purchase of specialized equipment. Upgrading or acquiring equipment to meet metrological traceability requirements often represents 20–30% of the total project budget.
Since the standard requires 100% of personnel involved in critical activities to be trained and competent, ongoing training and skills monitoring are necessary. This means anticipating a high volume of training, which may require additional staff or production adjustments to avoid delays and maintain quality.
A robust documentation system must be implemented to ensure traceability of procedures and protocols. Analytical methods must also be validated, including participation in proficiency testing to demonstrate result reliability.
Finally, audit preparation is a key step: using digital tools to centralize data and simplify compliance can make a significant difference. Proper preparation for the ISO 17025 audit reduces costs and audit time by avoiding document searches and non-conformities, resulting in substantial financial savings and time efficiency.
How Can a Digital Tool Help You Achieve ISO 17025 Certification?
Integrating digital tools is a key lever for simplifying compliance with ISO 17025 and reducing costs associated with manual management.
An Electronic Document Management System (EDMS) centralizes all documents in a single, secure space, ensures accurate tracking through version history, and guarantees that you are always working on the latest update. This centralization can reduce the time spent on document management by 25–40%, while minimizing the risk of errors and making audit preparation easier. In one place, you will find all essential information: procedures, protocols, certificates of analysis, reports, and other critical documents.
In addition, a dedicated competency and training management module is essential to meet the standard’s requirements. It ensures traceability of authorizations, schedules mandatory training, and provides employees with opportunities to update their knowledge. This approach helps boost motivation and team performance while reducing the risk of non-compliance.
Finally, self-assessment modules allow you to simulate an internal audit before the official visit. They help identify gaps, collect evidence (photos, documents, videos), and implement corrective actions in advance. This proactive approach reduces the risk of non-conformity and can accelerate audit and certification cycles by 15–20%, while strengthening the culture of continuous improvement.
ISO/IEC 17025:2017 remains the benchmark for testing and calibration laboratories, regardless of size or sector. It is a strategic lever for improving result reliability, optimizing processes, and gaining international recognition.
For biomedical laboratories, ISO 15189 applies. Historically, ISO 15189:2012 was mandatory in Quebec for public and private labs, in accordance with directives from the Ministère de la Santé et des Services sociaux (MSSS) and the accreditation process managed by the Bureau de normalisation du Québec (BNQ) and the SCC. However, this version has now been replaced by ISO 15189:2022.
Whether you are a biomedical laboratory or a testing and calibration lab, accreditation is much more than an obligation: it is an opportunity to strengthen your credibility, improve performance, and position yourself as a trusted player in the market. So, are you ready to turn this requirement into a competitive advantage?
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