ISO 17025 quality management system made simple.

ISO 17025, also referred to as ISO/IEC 17025, is the international standard for testing and calibration laboratories. It sets out requirements for the competence, impartiality and consistent operation of laboratories, ensuring the accuracy and reliability of their testing and calibration results.

The standard is published by the International Organization for Standardization (ISO) in collaboration with the International Electrotechnical Commission (IEC). It is reviewed for relevancy every five years. The most current version is ISO/IEC 17025:2017.

ISO 17025 is applicable to any size laboratory or facility that performs testing, sampling or calibration – any measurable result – and seeks to assure stakeholders of the competence of their systems and reliability of their results. Examples of industries covered by the rule include chemicals, forensics, automotive and food production.

Note that ISO 17025 does not apply to medical labs. Instead, ISO 15189 is the standard that specifies requirements for quality and competence in medical laboratories.

Requirements for ISO/IEC 17025 fall into five main categories:

1. General Requirements – Centered around impartiality and confidentiality
2. Structural Requirements – Covering management and employee involvement, and lab organization
3. Resource Requirements – Requirements for personnel, facilities, equipment, systems and support needed to optimally perform lab activities
4. Process Requirements – Core processes to improve efficiency, including selection, verification and validation of methods
5. Management Systems Requirements – Including documentation, document control, risk assessment, continuous improvement and corrective actions

For detailed information about ISO 17025 visit ISO/IEC 17025

Companies can be certified to ISO 17025 by an authorized, third-party accrediting body. Certification is not mandatory, however many organizations require this certification as a prerequisite to doing business.

Obtaining official certification shows customers and stakeholders that your lab resources and practices are competent and your results are trustworthy. Start by examining the standard and comparing it to your lab's current activities. Create a gap analysis and work on improving in necessary areas.

Both ISO 9001 and ISO 17025 are quality management systems. The biggest difference is that ISO 17025 is specific to testing and calibration laboratories. ISO 17025 and ISO 9001 have many similarities, including requirements for document control, risk management, resource management and corrective actions. Testing labs often use ISO 9001 alongside ISO 17025 to ensure that all aspects of quality management are addressed.

QT9 QMS offers 23-plus standard modules that help streamline and centralize ISO 17025 compliance, including document control, risk management, audit management and employee training. Our highly rated QMS is cost effective, easy to use and offers full customer support, an available ERP integration and Business Intelligence tool.