ISO/IEC 17025

About the ISO/IEC 17025 Resource Center

The ISO IEC 17025 Resource Center website is a unique source of information specific to the ISO/IEC 17025 standard and ISO 17025 laboratory accreditation. The information and documents provided on this site have been donated to benefit others in understanding what ISO 17025 is all about. This information will be of benefit to laboratories on the road to becoming accredited or to customers of laboratories in understanding the benefits of an ISO 17025 accreditation.  


REVISED!

The ISO/IEC 17025 international standard was recently revised in 2017.

 

Addition of processes rather than procedures, risk based thinking and management, identifying opportunities in business, quality and customer satisfaction, measured performance, prevention of negative impacts, effective improvements, separated technical and Management System Records.  


Risk based thinking applied in this version enables some reduction in prescriptive requirements and their replacement by performance based requirements. There is more latitude on how laboratories can implement the standard. For example, ISO/IEC 17025:2005 stated "the laboratory shall have policies and procedures to ensure protection of confidential information" and ISO/IEC 17025:2017 states "the laboratory shall ensure the protection of confidential information...". This can be accomplished with policies and procedures if the lab prefers or by evidence of records such as training, internal audit, etc.  


The laboratory needs a plan to address risks, however, there is no requirement for a formal risk management system or documented risk management process.

  

Contents of the ISO/IEC 17025:2017 International Standard

1. Scope

2. Normative References

3. Terms and Definitions

4. General Requirements  

5. Structural Requirements  

6. Resource Requirements  

7. Process Requirements  

8. Management System Requirements

Overview

 ISO/IEC 17025:2017 - General requirement for the competence of testing and calibration laboratories

ISO: International Organization for Standardization

IEC: International Electrotechnical Commission

17025: Unique standard number assigned by ISO

2017: Year standard was published

The ISO 17025 standard was re-issued in 2017 as a replacement to the 2005 version. There are now 5 requirements sections instead of the 2 requirements sections (section 4 and 5) from the 2005 version of the standard. The new requirement sections are as follows:

Section 4 - General Requirements: Impartiality and Confidentiality
Section 5 - Structural Requirements: Legal Entity, Management, Range of Laboratory Activities (NEW), Conformity, Availability and Authority of Resources, Personnel and Integrity
Section 6 - Resource Requirements: General, Personnel, Facility and Environment, Equipment, Metrological Traceability, External Products and Services
Section 7 - Process Requirements: Review of requests, tenders and contracts, Method Selection, Sampling, Handling of Customer Items, Technical Records, Evaluation of Measurement Uncertainty, Validity of Results, Reporting, Complaints, Nonconforming work, Control of Data and Information Management (NEW)
Section 8 - Management System Requirements: Options, Management System Documentation, Control of Management System Documentation, Control of Records, Risks and Opportunities, Improvements, Corrective Actions, Internal Audit, Management Reviews


 


ISO 17025 Quality Manual Template