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Among the accreditation programs offered by A2LA is the program for laboratories that perform sampling and measurement activities in the field. An organization interested in this accreditation scheme must apply the requirements from A2LA R219 – Specific Requirements – TNI Field Sampling and Measurement Organization Accreditation, in addition to requirements in the Guide of the National Institute NELAC, National Environmental Field Activities Program (NEFAP), and Field Sampling and Measurement Organization (TNI FSMO). These are additional requirements to the ISO/IEC 17025:2005 standard. For a laboratory to gain accreditation to this scheme, they must be accredited to ISO/IEC 17025:2017.
Next, we will talk about the requirements applicable to this type of organization, and we will explain its focus on the application of the sampling and measurement activities.
Sampling – Inspection Body vs Laboratory
To define the accreditation scheme needed by an organization, it is important to define the objective of the sampling activity and the organization that performs the sampling. The objective of sampling performed by an inspection body is taking a sample from a lot that is to be studied (the inspection lot/batch), to analyze in a testing laboratory, and in the end, determine the acceptability of the lot according to quality standards required for this lot. On the other hand, testing laboratories collect a portion of the environmental medium (water, soil, air, emission) as the representative that will be analyzed in the lab to determine its characteristics and verify compliance with the pre-established requirements for the medium.
ISO/IEC 17025:2017 Requirements
The organization interested in obtaining accreditation must comply with all the general requirements cited in ISO/IEC 17025:2017 that are applicable to their operations in relation to their field. Organizations must comply with requirements about impartiality, confidentiality, structure, resource requirements, process requirements, and quality management requirements for all sampling and measurement methods that they execute. All these requirements should be applied considering that the laboratory performs field activities, to say, outside of their facilities, and often, in conditions that are outside of their full control, for which the organization must take measures to ensure that they remain compliant with all requirements at all times.
Required A2LA Policies
For an interested organization to obtain the A2LA accreditation under the TNI FSMO scheme, it must comply with R103 General Requirements for Proficiency Testing; A2LA’s Requirements When Making Reference to A2LA Accredited Status (R105); and A2LA’s Policy on Metrological Traceability (P102).
TNI FSMO Requirements
TNI FSMO are the specific application requirements. The main guidelines of this requirement are described below:
- Regarding the organization, an organigram and the organizational structure including all lines of responsibility, considering the sampling and measurement activities, should be included to ensure adequate supervision by competent supervisors.
- Regarding the Quality System Management, TNI FMSO requires that all procedures, plans, and policies that are required by ISO/IEC 17025:2005 be documented in the quality manual. The quality policy and all quality system policies should be included, as well as management system procedures related to document and record control, subcontracting, corrective/preventative actions, opportunities for improvement, and management review, and the technical procedures related to measurement uncertainty calculations, reporting of results, and metrological traceability.
- As for specific procedures, TNI FSMO requires a procedure for the integrity of data, which much guarantee that the organization maintains a high ethical approach to field sampling and measurement, as the key component of the entire planning and implementation of the methods relate to FSMO activities.
- The FSMO organization must also create a plan that ensures that records are being kept or transferred in accordance with the client’s instructions in case the FSMO transfers ownership or is closed. It should include plans to follow appropriate state and legal requirements in case the FSMO goes bankrupt.
- For internal audits and management reviews, FSMO requires that these activities are performed at least once a year. Additionally, the internal audits should include the activities of sampling and measurement in the field.
- With respect to the requirements related to personnel, TNI FSMO requires that the organization maintains evidence of personnel training, such as courses, specific training sessions on themes related to the handling and operation of equipment, and specific techniques and procedures for field sampling and measurement. Additionally, it is necessary to demonstrate that personnel read, acknowledge, and understand the procedures for data integrity. It should also be demonstrated that the personnel responsible for field sampling and measurement activities has read, understood, and accepted to perform the environmental field sampling and measurement in accordance with the most recent version of the current operative methods and procedures.
- For the field sampling and measurement processes, TNI FSMO require procedures and records for the selection of the field sampling and measurement points; recollection, conservation, and transport of the samples, and the proper operation of the equipment used in the field and the conditions under which they need to be operated.
- For equipment used in field sampling and measurement, as well as metrological traceability of said operations, the organization must demonstrate that the equipment maintains its calibration range for the period of time required for completing the measurement or sampling and must also demonstrate that the environmental conditions are maintained in appropriate ranges for sampling and measurement. All these measurements must ensure, as much as possible, to corresponding metrological traceability according to the case of the monitored magnitudes/characteristics. If so, calibration procedures according to the type of instrument must be created. Likewise, it is important to keep calibration/verification records for equipment used patterns, materials, acceptance criteria, and calibration and verification periods.
- When it comes to proficiency testing participation, the FSMO organization must participate in PT programs that are applicable to the field tests.
- In the sampling and measurement test reports issued by FSMO organizations, there should be a clear description and information of the sampled item, including the identification of the sampled matrix; the location of the sampling point and diagrams, if necessary; the name and title of the person authorizing the report; field quality control results such as field blanks, fortified, duplicates, and samples for confirmation; a reference to the sampling plan and procedure, including information about preservation, transportation, and storage of the sample; chain of custody; and a unique identification for each sample container. The test reports should include information about any calibration, verification, and adjustments made to the equipment used as well.
Finally, together with these requirements, organizations must also comply with the applicable international, national, and local standards, as well as with the specific criteria of the authorities, where applicable. Currently, multiple laboratories that perform field sampling and measurement in water, soils, waste, air and fixed sources of emissions, and gases are accredited against this scheme.