Resource Requirements of ISO 17025September 4, 2019 2021-09-08 7:40
Resource Requirements of ISO 17025
Resource Requirements of ISO 17025
Resource Requirements of ISO 17025 For Quality Management Software
Testing and calibration laboratories use the resource requirements of ISO/IEC 17025 to develop their management system for quality, administrative, and technical operations.
Furthermore, ISO 17025 accreditation is essential in improving a laboratory’s reputation.
Part of the process of accreditation is knowing the standard’s resource requirements.
Clause 6 – Resource Requirements, is composed of six subclauses:
- 1 General
- 2 Personnel
- 3 Facilities and Environmental Conditions
- 4 Equipment
- 5 Metrological traceability
- 6 Externally Provided Products and Services
6.1 General Resource Requirements
Resource requirements include personnel, equipment, facilities, systems, and support services. ISO 17025 requires the laboratory’s internal and external personnel to be competent and have an impartial stance. This covers personnel who are directly involved in testing/calibration/sampling activities. Likewise, personnel who is indirectly involved, such as technical personnel.
An ISO/IEC 17025 accredited laboratory must have competent internal and external employees. Employees must work within the structure of the laboratory’s management system.
Each job function of a laboratory needs proper documentation. This covers job descriptions, detail competence, authorization of laboratory personnel, supervision, and training.
Laboratory management must use personnel performance reviews or regular meetings to communicate the duties, responsibilities, and authorities to laboratory personnel.
The management must communicate to personnel their responsibilities, duties, and what work they are authorized to do. The laboratory must have procedures and keep records for:
- Identifying the competence requirements
- Selecting personnel
- Training personnel
- Supervision of personnel
- Authorization of personnel
- Competence of personnel
Personnel has to have authorized tasks for:
- Creation, amendment, verification, and validation of methods
- Analysis of results
- Reports, reviews, and authorization of results
6.3 Facilities and Environmental Conditions
Concerning ISO 17025 facilities and environmental conditions, the laboratory must be apt to execute all his activities in environmental conditions that don’t affect results. Similarly, the laboratory must not impact the validity of the results, he must document, control, monitor, and record all laboratory conditions.
Control the laboratory’s environment to guarantee that results won’t be compromised. These environmental conditions can impact your laboratory:
- Electrical supply
Define and control laboratory activity areas. Separate those from areas with incompatible laboratory activities. This will avoid interference with the activities or contamination.
For activities done offsite, the laboratory must fulfill the environmental conditions in ISO 172015.
The laboratory must have access to the proper equipment crucial for the performance of laboratory activities.
Establish a documented calibration program that includes:
- Records for all equipment that can influence laboratory activities. These include the equipment’s use, handling, transport, maintenance, and storage.
- Identification of calibration status, including out-of-service and non-calibrated equipment.
- Tamper resistance program to safeguard unauthorized adjustments that would invalidate the equipment’s calibration status.
6.5 Metrological Traceability
ISO 17025 laboratories must set and preserve metrological traceability of their measurement results. They must use a documented unbroken chain of calibrations, each contributing to measurement uncertainty and connecting them to a suitable reference. Laboratories must give objective evidence.
The measurement results must be traceable to the International System of Units (SI) in one of these three ways:
- Direct realization of the SI units by comparison with national or international standards;
- A competent laboratory’s calibration;
- Certified values of certified reference materials given by a competent producer with stated metrological traceability to the SI.
The laboratory must show metrological traceability to a fitting reference if the measurement is not traceable to the SI.
6.6 Externally Provided Products and Services
ISO/IEC 17025 laboratories need to ensure that only satisfactory externally provided products and services, which may impact the laboratory’s activities, are used when products and services are:
- intended for incorporation into the laboratory’s activities
- are used to support the laboratory’s operation
- are provided directly to the customer by the laboratory, as received from the external provider
According to ISO/IEC 17025, the laboratory should have a procedure and keep records for:
- Guarantee externally provided products and services to fulfill the laboratory’s requirements.
- Determining, reviewing, and approving requirements for externally provided products and services.
- Defining the basis for evaluation, selection, monitoring of performance, as well as a re-evaluation of the external providers.
- Actions coming from evaluations, monitoring, or performance of external providers.
The laboratory must communicate requirements to external providers such as:
- Acceptance criteria
- Competence, including a personnel qualification
- Activities that the laboratory, or its customer, plans to conduct at the external provider’s premises.
Certain text from the ISO 17025 standard is used for instructional purposes. Standard Stores recognize and respect the International Organization for Standardization (ISO) copyright and intellectual property guidelines.
QSE Academy has packages and toolkits that can help your laboratory comply with the resource requirements of ISO 17025. Our consultants can also assist you with the templates, forms,