ISO 17025 Standards
ISO/IEC 17025 is the main ISO Standard for the competence of testing and calibration laboratories and is used worldwide.ISO 17025 Standards
- ISO/IEC 17025:2017 general requirements for the competence of testing and calibration laboratories
- ISO/IEC 17043:2010 Conformity assessment – General requirements for proficiency testing
What are the ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories?
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the fundamental ISO standard used for testing and calibration laboratories. ISO/IEC 17025 is used for most labs in major countries, and these labs must hold accreditation in order to be considered technically competent. ISO/IEC 17025 was originally known as ISO/IEC Guide 25 and was issued by ISO in 1999.
Although there are many similarities to ISO 9001, ISO/IEC 17025 is specific to laboratories and has more requirements regarding competence applying directly to organizations that produce testing and calibration results. Initially released in 1999, the standard was revised in 2005 to better match ISO 9001:2000, and 12 years later was revised with ISO/IEC 17025:2017. Created by the International Organization for Standardization (ISO), ISO 17025:2017 abides by international requirements and guidelines.
To align with the latest market conditions and technological advancements, the new edition of the standard includes the current activities and modern practices of laboratories. It addresses technical updates, new terminology, and IT developments, while also incorporating the latest version of ISO 9001 on quality management.
ISO/IEC 17025 has a list of set requirements with guidelines and information. Many organizations like to use the phrase ISO 17025 certified, but rather, what they mean is that they have met the requirements of the standard. Read more about ISO/IEC 17025 Accreditation.
The series is not industry specific and is applicable to any manufacturing, distribution or service organization. It is managed by Technical Committee (TC) 176, comprised of international members from many industries and backgrounds.
ISO/IEC 17025 fosters collaboration between laboratories and other organizations by promoting broader acceptance of results across countries. This standard allows test reports and certificates to be recognized internationally without additional testing, thereby enhancing global trade.
What are the older (obsolete) ISO 17025 quality standards?
ISO/IEC Guide 25 was the original competence of testing and calibration laboratories standard introduced in 1999.
ISO/IEC 17025:2005 was introduced to better match ISO 9001:2005.
ISO/IEC 17025:2017 was introduced 12 years older in order to keep up with the changing market and in general to comply with ISO 9001:2015.
What standards support ISO 17025?
Other ISO quality standards were created to support the ISO 17025 Standard:
What are the main changes in the 2017 version?
- The scope has been updated to include testing, calibration, and sampling related to subsequent calibration and testing.
- The process approach now aligns with newer standards like ISO 9001 (quality management), ISO 15189 (quality for medical laboratories), and ISO/IEC 17021-1 (requirements for audit and certification bodies).
- The standard now places greater emphasis on information technologies, incorporating the use of computer systems, electronic records, and the generation of electronic results and reports.
- A new chapter presents the concept of risk-based thinking.
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