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The key changes between the 2005 and 2017 Versions of the ISO/IEC 17025 standard

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According to the standard announcement, general requirements for  the competence of the testing and calibration laboratories : TIS 17025-2561 (ISO / IEC 17025-2017) "resulting in every laboratory to change the quality management system to comply with the new version of the standard TIS 17025-2561 (ISO / IEC 17025-2017). This can be used all organizations performing testing, calibration and / or sampling.

The new version of standard provides an update in ;
- Terminology, Formerly, the terms will be based on ISO / IEC 17000 and VIM. The new version will follow ISO / IEC 17000 and ISO / IEC Guide 99.
- Process approach, whereby the standard is aligned with other recent standards such as: ISO 9001
- Scope
- The recent was up-to-date IT technology
- The concept of risk-based thinking, the new topic introduced in Thai version.
comparing the main topics of version 2005 and 2017, the 2017 version is adjusted to be in accordance with standards in the ISO / IEC 17000 series specified as in the table.

When comparing the scope of ISO/IEC 17025 : 2005 with the scope of ISO/IEC 17025 : 2017 version, it is noted that the 2017 version specifies the general requirements for the competence, impartiality, and consistent operation of laboratories.

Additionally, in the normative reference section of ISO/IEC 17025 : 2017, ISO/IEC Guide 99 is listed as a reference which provides the basic and general concepts, and associated terms with ISO/IEC 17000. There is listed as a reference, which specifies the vocabulary and the general principles for conformity assessment.

The terminology has been updated as well, which means that the ISO/IEC 17025:2017 standard covers the newest ISO/IEC terminology and the changes that have been included in the International Vocabulary of Metrology (VIM). Under the section terms and definitions of the ISO/IEC 17025 : 2017 standard, the term “laboratory” has been added. This term refers to the bodies that perform one or more of the following activities such as testing, calibration, and/or sampling, associated with subsequent testing or calibration.

It is important to mention 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.

Main requirement of the 2017 version of ISO/IEC 17025 can be divided according to the following main requirements.

1.General requirements : this clause includes impartiality and confidentiality, whereby the laboratory activities are to take into account impartiality and safeguard the confidentiality of all the information obtained during the execution of laboratory activities.

2.Structural requirements : this clause represents the legal entity that defines and documents the range of laboratory activities. Additionally, it identifies the management, the laboratory activities, the organization and management structure, the responsibility, authority and interrelationships of all personnel.

3.Resource requirements : This clause highlights the importance of the provision of the resources such as the personnel, facilities and environmental conditions, equipment, metrological traceability, and the externally provided products and services used to support the operation of the laboratory.

4.Process requirements : In this clause, it its mentioned that the process requirements are deployed as follows :
• Review of requests, tenders and contracts
• Selection, verification and validation of methods
• Sampling
• Handling of test or calibration items
• Technical records
• Evaluation of measurement uncertainty
• Assuring the validity of results
• Reporting of results
• Complaints
• Nonconforming work
• Control of data – Information management


 
5. Management system requirement : This clause states that the laboratory has two options to choose when implementing a management system, option A or option B

Option A : This option lists the main requirements for implementing a Laboratory Management System. This means that the Laboratory can implement directly a management system based on the requirements of ISO/IEC 17025. In addition, the laboratory can choose to incorporate the requirements of ISO 9001 that  are relevant for performing laboratory activities.

Option B : When a laboratory  chooses to implement a management system through option B, they have to operate in accordance with the requirements of ISO 9001, in a way that fulfills requirements 4 to 7 of the ISO/IEC 17025 standard.

However, as it is stated in ISO/IEC 17025, both options are intended to achieve the same result in the performance of the management system and compliance with clauses 4 to 7. the change in the 2017 version of the ISO/IEC 17025 standard is the modification of the Annexes A (informative) Metrological traceability and Annexes B (informative) Management system options
 
The certification of ISO/IEC 17025-2005 will expire on November 28, 2020 (refer data of the Thai Industrial Standards Institute). Therefore, the laboratory who hold ISO/IEC 17025-2005, should apply for ISO/IEC 17025-2017 with the certification body from now on.




 
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