What is ISO 17025?

ISO 17025 is the international standard that specifies requirements for testing and calibration laboratories regarding technical competence, result reliability, and the effectiveness of their quality-management system. Laboratories adopt it to ensure consistent operations, global acceptance of their results, and alignment with international expectations.

Scope of ISO 17025

The standard has two pillars: quality-management requirements and technical requirements. Laboratories must demonstrate not only competence in testing and calibration but also robust control of documentation, risk, and corrective actions.

  • Quality management — document control, risk analysis, quality policy, continual improvement,
  • Technical requirements — staff competence, method validation, equipment control, measurement traceability,
  • Impartiality and independence — eliminating conflicts of interest to secure objective results,
  • Sample and data handling — consistent identification, recording, and reporting of results.

Purpose of implementing ISO 17025

Implementing ISO 17025 confirms laboratory competence and boosts confidence in test and calibration results. Accreditation under this standard is recognised internationally and is often required by clients, notified bodies, or regulators.

  • Greater credibility of results and reports,
  • Satisfaction of customer and regulatory requirements,
  • Streamlined internal processes and error reduction,
  • Easier international collaboration and mutual recognition of results (ILAC MRA).

Who should implement ISO 17025?

The standard addresses testing and calibration laboratories of any size—public or private—including:

  • industrial and control laboratories,
  • academic and research labs,
  • labs performing tests for medical-device conformity assessment,
  • facilities supporting manufacturers’ quality systems.

For medical devices, ISO 17025 accreditation strengthens the credibility of test data required during conformity assessment. Under the MDR and IVDR, notified bodies may demand evidence generated by independent, accredited laboratories. ISO 17025 provides the framework for such analyses, including:

  • validation of measurement and test methods,
  • quality control of analytical data,
  • trend monitoring, complaint analysis, and product-stability studies.

The standard can be integrated with ISO 9001, ISO 13485 (for labs serving med-tech manufacturers), and ISO 15189 (for medical laboratories).

Phases of ISO 17025 implementation

Rolling out an ISO 17025-compliant system should follow planned stages to achieve full conformity and accreditation readiness:

  1. Initial assessment — identify gaps and evaluate technical competence,
  2. Documentation development — quality policy, procedures, work instructions, and records,
  3. Training & rollout — prepare personnel to operate under the new system,
  4. Internal audit & management review — verify compliance and readiness for accreditation,
  5. Accreditation audit — assessment by the national body (e.g. PCA in Poland) or a foreign accreditation service.

Maintaining and developing the ISO 17025 system

After accreditation, the lab must keep conforming to the standard through:

  • routine internal audits and management reviews,
  • monitoring quality indicators, non-conformities, and CAPA,
  • updating system documentation,
  • ongoing staff training and competence maintenance,
  • oversight of equipment, calibrations, and instrument checks.

ISO 17025 accreditation is valid for four years and requires annual surveillance visits.

Benefits of ISO 17025 implementation

Adopting the standard yields internal and external advantages:

  • international recognition of results (ILAC, EA MLA),
  • greater trust from customers and notified bodies,
  • more efficient testing and measurement processes,
  • higher laboratory competitiveness and eligibility for tenders and research projects,
  • lower risk of measurement errors and complaints.

Challenges in implementing ISO 17025

Common hurdles include:

  • extensive system documentation,
  • stringent method-validation and traceability requirements,
  • costs of equipment, training, and accreditation audits,
  • continuous preparedness for surveillance audits,
  • the need for interdisciplinary technical and managerial expertise.

How Pure Clinical supports ISO 17025 implementation

ISO 17025 deployment demands precision, technical-standard knowledge, and accreditation experience. Pure Clinical offers end-to-end assistance—from initial audit to accreditation readiness:

  • ISO 17025 gap analysis and compliance assessment,
  • development of system documentation: procedures, policies, and forms,
  • training laboratory staff in ISO 17025 and quality management,
  • support for validation of test and calibration methods,
  • conducting internal audits and preparing for the accreditation visit (e.g., PCA),
  • adapting the system for collaboration with medical-device manufacturers in the MDR/IVDR context.

We help laboratories achieve and maintain accreditation—meeting the demands of clients, notified bodies, and international projects.

FAQ

Does a laboratory certified to ISO 17025 also need to implement ISO 9001?

No, ISO 17025 already includes quality system requirements tailored for laboratories. While ISO 9001 is not mandatory, it may be beneficial for organizations with broader scopes such as combined manufacturing and testing facilities.

What traceability data must be maintained under ISO 17025?

Laboratories must retain complete calibration records, including equipment ID, calibration certificates, measurement uncertainty, and environmental monitoring. These records ensure measurement traceability and audit transparency.

Can non-standard methods be used under ISO 17025 if validated?

Yes, non-standard or in-house methods are acceptable if they are fully validated and shown to be fit for purpose. Documentation of the method's performance and client approval are required for compliance.

What are common nonconformities found in ISO 17025 audits?

Frequent issues include lack of method validation records, poor sample traceability, unmonitored lab environments, outdated procedures, and inadequate corrective action (CAPA) documentation and follow-up.