The ISO/IEC 17025 standard specifies the requirements for the competence of testing and calibration laboratories, which has been developed specifically for guiding laboratories to cover every aspect of laboratory management system. The requirements of the ISO/IEC 17025:2017 version of the standard are applicable to all organizations performing testing, calibration, and/or sampling.
ISO/IEC 17025:2005 vs. ISO/IEC 17025:2017
With beginning of the ISO/IEC 17025:2005 version included the following:
- Scope
- Normative references
- Terms and definitions
- Management requirements
- Technical requirements
Whereas, the ISO/IEC 17025:2017 version includes the following:
- Scope
- Normative references
- Terms and definitions
- General requirements
- Structural requirements
- Resource requirements
- Process requirements
- Management system requirements
When the thing is to compare the scope of ISO/IEC 17025:2005 version with the scope of ISO/IEC 17025:2017 version, it is noted that the 2017 version of the ISO/IEC 17025 standard considers the general requirements for the competence, impartiality, and consistent operation of laboratories.
In Addition, in the reference section of ISO/IEC 17025:2017, ISO/IEC Guide 99 is listed as a reference which gives the basic and general concepts, and associated terms. ISO/IEC 17000 is also listed as a reference, which considers the vocabulary and the general principles for conformity assessment.
As well as the terminology has been updated, which means that the standard of ISO/IEC 17025 with 2017 version covers the newest ISO/IEC terminology and the modifications that have been included in the International Vocabulary of Metrology (VIM). In the section terms and definitions of the ISO/IEC 17025:2017 standard, the term "laboratory" has been added.
This term mentions to the bodies that perform one or more activities such as testing, calibration, and/or sampling, associated with subsequent testing or calibration. It is very important to specify that the newest standard focuses more on information technology, mainly in the use of systems, the provision of electronic test results, and the provision of electronic records.
Documents Requirements for ISO/IEC 17025:2017
When laboratories are going for accreditation, there is required to be fulfilled some specific ISO/IEC 17025:2017 documents as well as ISO 17025 documents are beneficial to design and develop testing and calibration laboratories.
There are various categories are available to fulfil such requirements for better understanding and defining quality systems in laboratory as per the ISO/IEC 17025:2017 standard. The document categories are as following:
- ISO 17025 Quality Manual
- Quality Procedures
- Exhibits
- Word Instructions
- Standard Operating System
- Forms / Record Templates
- ISO 17025 Audit Checklist
