What is ISO 17025? How Did it Start?
The ISO 17025 standard helps maintain the quality of laboratory services by governing laboratory operations and procedures, as well as the technical quality of data provided by the laboratories.
The origins of ISO 17025 can be traced back to EN 45001 and ISO/IEC Guide 25. The first revision of ISO 17025 was released in 1999, the 2nd revision in 2005, and the most current being released in 2017.
The sections of the ISO 17025:2017 standard are as follows:
What Type of Businesses are Accredited?:
The most common type of businesses adhering to ISO 17025 are:
The ISO 17025 standard offers key advantages for both users and providers. Users of ISO 17025 laboratory services benefit from enhanced data reporting that makes it possible to compare measurements from different laboratories — even those from multiple countries. The enhancement and standardization of laboratory data provides companies an increased level of confidence in their test instrument accuracy.
What are the Auditing Requirements?:
Becoming and maintaining accreditation to the ISO 17025 standard requires two types of auditing:
1. Internal Audits – Audits by internal or contracted staff that are specifically trained to the ISO 17025 standard and internal procedures/requirements.
2. External Audits – Auditing by an external accreditation body.
Internal Auditing is key to understanding compliance of the company to the requirements of the ISO 17025 standard. It requires review and assessment to verify that the current quality system is effective – and if not, to correct and prevent any identified issues. ISO 17025 has very clear requirements regarding the internal audit process, as evidenced by the excerpt below from Section 8.8:
“The laboratory shall conduct internal audits at planned intervals to provide information on whether the management system:
a) conforms to:
— the laboratory’s own requirements for its management system, including the laboratory activities;
— the requirements of this document;
b) is effectively implemented and maintained.”
“The laboratory shall:
a) plan, establish, implement and maintain an audit programme including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the laboratory activities concerned, changes affecting the laboratory, and the results of previous audits.”