With the end of the year wrapping up, it also means that the ANAB deadline for the transition to ISO/IEC 17025 could quite possibly be here for you.  Beginning January 1, 2019, it will hold laboratories seeking accreditation to the requirements of the 2017 standard.

What is ISO/IEC 17025?

The International Organization for Standardization (ISO) is an international standard-setting body comprised of representatives from various national standards organizations.

ISO/IEC 17025 specifies general requirements for laboratory competence, impartiality, and consistency in tests and calibrations.  ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.

They review a standard every 5 years.  In 2017, they updated it to reflect the latest changes in laboratory environments and work practices.  Making the ISO/17025: 2005 obsolete and the standard revised to IS0/17025:2017.

The Changes to the Standard

The new edition of the standard covers technical changes, vocabulary, and developments in IT techniques.

• Scope – The revisions cover testing, calibration, and sampling associated with subsequent calibration and testing.
• Structure – A new structure has been adopted to align the standard with the other existing ISO/IEC conformity testing standards.  Such as the ISO/IEC 1700 series on conformity assessment.
• Process Approach – It now matches that of newer standards like ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17012-1 (requirements for audit and certification bodies).
• Terminology – They have updated the ISO/IEC terminology. In addition to phasing out hard copy manuals, records, results, and reports for electronic versions.
• New Chapter – The concept of risk-based thinking. This ensures that risks are identifiable, consideration, and controlled throughout the design and quality management system. It also describes commonalities with the new version of ISO 9001:2015.

The Benefits of the ISO/IEC 17025:2017

Specifically, one of the main benefits is that your laboratory will gain international recognition for its commitment to quality, competency, and reliable results.

Accreditation is also an objective way to assure your customers that you have the technical competence to provide reliable and accurate test or calibration results.  This serves as an unbiased guarantee that your lab is performing at its highest level.

Another key point is that you can set your lab apart from competitors.  By aiming to control quality costs, improve measurement accuracy and guarantee consistency results, ISO/IEC 17025 is an ideal management system model for labs.  The elements work together to ensure that the required quality levels are met and the satisfaction of the customers’ needs.  For this reason, it is a powerful strategic tool for the competitive market.

Positive Financial Impact on Your Business

Having an international label and standard to attest to the reliability of laboratory results, especially between laboratories in different countries, allows the recognition of test results without having to reproduce the test from one country to another.

With the new standards, a laboratory can ensure that its electronic test results, reports, and records are compliant, and customers are confident with the results which can be trusted around the world.