In Colombia, the technical competence of testing laboratories is determined by compliance with the requirements of ISO IEC 17025 standard, which has been modified in its 2005 version to ISO IEC 17025:2017.
This new version proposes a structure more compatible with quality standards such as ISO 9001, updates the terminology including the International Metrology Vocabulary and ISO updates that have common terms and definitions for all standards related to conformity assessment.
In order to make the transition, it is important that the management system of each laboratory identify which are the main changes and impacts that could occur. Among the most relevant are:
- The 17025: 2017 version, adopts the evaluation of risks and opportunities aimed at preventing negative effects on results.
- Impartiality is included as a numeral within the general requirements unlike the 2005 version that mentioned it between lines of requirements related to management.
- Section 5.5.2, 2005 version, gave the “Calibrate or Verify” option, the 2017 version only contemplates the “Calibrate” option.
- It is generally established that the methods performance must be specified in the validation.
- In number 7.9 of the current version there is a greater interest in the treatment of complaints.
- Describing a Quality Manual within the system is not a mandatory requirement for the 2017 version.
The above applies for accredited laboratories and in the process of initial granting with transition periods that will be defined by the accrediting entities.
On the other hand, it is important to mention that the new versions of reference methods such as the ASTM Standards and the Standard Method, add to the testing laboratories a permanent revision and adjustment of the internal methodologies, in addition to validations and periodic confirmations that allow changes in the limits of quantification, control patterns, among others, that are related to the assurance of the quality of the results; to mention an example, the new version SM Edition 23: 2017, Section 4500-NO3, establishes 11 changes with respect to 22 version of the year 2014.
The aforementioned changes have as main objective, to strengthen the reliability of the results; these also obey to different market conditions and new technological advances, which generate the need to adapt the corresponding reference methods. Finally, this shows us that quality must be prepared and subject to a process of continuous improvement and change management.