6.1 General Resource Requirements
Resource requirements encompass personnel, facilities, equipment, systems and support services. The 17025 standard requires all internal and external personnel of the laboratory to be competent and have an impartial stance. This includes personnel who are directly involved in testing/calibration/sampling activities, and also personnel who is indirectly involved, like technical personnel. Learn more about employee training.
To be an ISO/IEC 17025 accredited lab, all personnel of the laboratory, both internal (i.e., employees) or external (i.e., contractors), must be competent and work within the structure of the laboratory’s management system.
Laboratory management shall communicate the duties, responsibilities and authorities to laboratory personnel through regular meetings or personnel performance reviews.
Management are required to communicate to personnel their duties, responsibilities and what work they are authorized to perform. In addition, the lab must have procedures and retain records for:
- determining the competence requirements
- choosing personnel
- training personnel
- supervision of personnel
- authorization of personnel
- competence of personnel
The following tasks that personnel perform need to be authorized:
- Development, modification, verification, and validation of methods
- Analysis of results
- Reports, reviews and authorization of results
6.3 Facilities and Environmental Conditions
Regarding the ISO 17025 facilities and environmental conditions, the laboratory needs to be suitable to perform all activities and not affect the validity of the results. As a laboratory the conditions must be:
You must control the environment of your laboratory to ensure that you do not compromise your results. Environmental conditions that could impact your lab include:
- Electrical supply
Laboratory activity areas must be:
- Separated from areas with incompatible laboratory activities to prevent contamination or interference of the activities.
If any activities are performed offsite, the laboratory needs needs to ensure that all of the environmental conditions defined in this standard are met.
The laboratory shall have access to the proper equipment required for the performance of laboratory activities.
A documented calibration program will need to be established that includes:
- Records for all equipment which can influence laboratory activities, including the handling, transport, storage, use and maintenance of equipment
- Identification of calibration status, including non-calibrated and out of service equipment
- Tamper resistance program to safeguard unauthorized adjustments that would invalidate the calibration status of the equipment.
6.5 Metrological Traceability
ISO 17025 laboratories must establish and maintain metrological traceability of their measurement results using a documented unbroken chain of calibrations, each contributing to measurement uncertainty and linking them to an appropriate reference. Laboratories must provide objective evidence.
The measurement results need to be traceable to the International System of Units (SI) in one of these three ways:
- Calibration provided by a competent laboratory
- Certified values of certified reference materials provided by a competent producer with stated metrological traceability to the SI
- Direct realization of the SI units ensured by comparison, directly or indirectly, with national or international standards
If the measurement can not be traceable to the SI, the laboratory must demonstrate metrological traceability to an appropriate reference.
6.6 Externally Provided Products and Services
ISO/IEC 17025 laboratories need to ensure that only satisfactory externally provided products and services that may or do impact the laboratory’s activities are used when products and services are:
- intended for incorporation into the laboratory’s own activities
- are provided directly to the customer by the laboratory, as received from the external provider
- are used to support the operation of the laboratory
As defined in ISO/IEC 17025, the laboratory must have a procedure and maintain records for:
- Defining, reviewing and approving requirements for externally provided products and services
- Defining the basis for evaluation, selection, monitoring of performance and re-evaluation of the external providers
- Ensuring that externally provided products and services meet the lab’s requirements
- Actions arising from evaluations, monitoring or performance of external providers
The laboratory must also communicate requirements to external providers including:
- Acceptance criteria
- Competence, including any required qualification of personnel
- Activities that the lab, or its customer, intens to perform at the external provider’s premises
Please note that certain text from the ISO 17025 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.