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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
2. Normative References
3. Terms and Definitions
4. General Requirements
5. Structural Requirements
6. Resource Requirements
7. Process Requirements
8. Management System Requirements
ISO/IEC 17025:2017 - General requirement for the competence of testing and calibration laboratories
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