ISO 17025: 2017 is the standardized Norm that regulates the activity of testing and calibration laboratories to ensure technical competence and the reliability of the results obtained through any type of procedure that the laboratory wants to submit to accreditation based on the methodology or analytical resources available.
The Standard, in its 2017 revision, expands the general, structural, process, resource and management requirements that laboratories must ensure to be accredited. Also, it introduces the analysis of risks and opportunities as an element that allows reducing uncertainty (and therefore error) in its measurement processes. Through accreditation, it is demonstrated that “they operate competently and have the ability to generate valid results.”
The general requirements correspond to the structure of the documentation, both process and commercial, and its management, as well as other aspects of a quality management system (post-sale, non-conformities, corrective actions, auditing, etc.) analogously to that contained in ISO 9001. A novelty introduced with respect to the 2005 edition is the introduction of the concept of ‘impartiality’ and ‘confidentiality’ to protect both laboratory personnel against external pressure and the interests of the client regarding the property of the analytical result.
The structural requirements refer to the involvement of the laboratory with respect to the quality system itself and the activities that fall under the scope of the accreditation, defining the organizational structure of the same.
The resource requirements point to the need to have personnel with the necessary technical skills, facilities and adequate equipment to carry out the process, as well as to define the responsibilities of all technical and management personnel who direct, carry out or verify processes with impact on results, including activities and supplies provided by third parties, such as calibrations and consumables.
The management requirements, point to the procedures to maintain and improve the quality system, and include risk and opportunity management, continuous improvement processes, internal audits and management of corrective and preventive actions.
The process requirements constitute the main block of the Standard and affect all the activities of the analytical process, from the request for analysis, sampling and identification of the sample, custody and storage, measurement methodology, calculation of uncertainty and traceability and veracity of the result.
The wine cellar laboratory can benefit from adopting standardized procedures that include the elements of the standard that allow them to operate competently and generate valid results, especially in all those tests that, due to their characteristics, require a result that does not allow for delays associated with outsourcing the analysis. The requirements related to the most relevant resources and processes would be:
- 6.4 Equipment: Very particularly those referring to calibration and reference material, reagents in accordance with official methods and the state of calibration (and associated uncertainty) of measuring tools.
- 6.5 Metrological traceability: Establish and maintain it, quality control.
- 6.6 Products and services supplied externally: Adequacy and conformity to needs, evaluation and monitoring of performance.
- 7.1 Review of applications, offers and contracts: Adequacy and validity of the method according to the official standard for testing.
- 7.2 Selection, verification and validation of the test method.
- 7.3 Sampling.
- 7.6 Measurement of uncertainty.
- 7.7 Assurance of the validity of the results: internal and external control.
- 7.8 Results reports.
- 7.11 Data control and information management.
- 8 Requirements of the management system: organization, records, documentation, auditing, analysis of risks and opportunities, corrective actions, … (similar to the existence of ISO 9001).
By adopting many of the requirements contained in ISO 17025 within the winery’s management system, the analytical process itself is greatly facilitated and the degree of reliability is increased when using the data obtained in decision-making, while maintaining consistency and traceability of the results. These aspects are especially useful for the winemaker to take the mandatory technical decisions throughout the winemaking process.
It is important to note that accreditation is not an essential requirement for an oenological laboratory just focused on the control of the winemaking process, such as the one implemented within the winery (although it will be when the results have value for the purposes of certification or issuance of official documents with legal or commercial value). It is highly advisable, however, for oenological laboratories that provide their services to wineries, since it constitutes a guarantee of their reliability and technical competence. It is also noteworthy that the accreditation covers exclusively those analytical activities that the laboratory decides and thus must be stated in the accreditation document.
In the case of oenological analysis, the OIV is the international body in charge of defining the official methods for all relevant parameters and, therefore, methods susceptible of accreditation under ISO 17025. Among them, the following are of special relevance automated enzymatic and colorimetric methods that, although relatively recent compared to some of the traditional methods, provide a high degree of reliability with a very simple technical implementation. For this reason, they are progressively replacing the original methods because they are much more efficient and effective in their implementation in the winery.
Sinatech has a wide range of reagents based on official methods that can be implemented both in the winery for the determination of reducing sugars and acids, easily automated and offering accurate and truthful results.
SY2401 / SD6001
SY2405 / SD6005
SY2402 / SD6002
SY2403 / SD6003
SY2420 / SD6020
SY2406 / SD6006
SY2404 / SD6004
Glucose + Fructose