Clause 5: Structural Requirements
Clause 5 identifies the structural requirements.
To become ISO/IEC 17025:2017 accredited, the laboratory must define and document the following about the laboratory operations:
- The organizational structure
- The management with responsibility
- The responsibility of the laboratory personnel
- The activities of the laboratory
The laboratory will need to have personnel authorized to ensure that regular communication takes place regarding:
- Implementation and improvement of the management system
- The effectiveness of the management system
- The importance of meeting customer as well as regulatory requirements
The laboratory is required to document its procedures in order to produce consistency of its activities and to ensure that the results are valid. Typically, the laboratory’s processes are documented with a quality manual, standard operating procedures and work instructions. The new standard has clearly identified the requirement that the lab must only claim conformity with ISO 17025:2017 standard for this range of laboratory activities. This excludes externally provided laboratory activities on an ongoing basis. Meaning, the lab is expected to be accredited and must include in its scope of accreditation only testing/calibration/samping activities that are utilizing its own resources. This standard states that the lab can only be accredited for the laboratory activities for which it is competent. Subcontracting can only be allowed for extenuating circumstances, which may include work overload, sickness of personnel, etc.
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.