Recapping what we’ve tackled in the first part, the new ISO/IEC 17025:2017 requirements apply to all organizations conducting laboratory activities, regardless of the company size.
The standard includes requirements for competence, impartiality, and consistent laboratory operations.
In the second part of our series, QSE Academy continues to explain the requirements that your laboratory should adhere to.
Clause 6 – Resource Requirements of ISO/IEC 17025:2017
Resource requirements include personnel, equipment, facilities, systems, and support services essential to conduct and handle the laboratory activities.
It expects all internal and external personnel of the laboratory to be competent and act impartially. This standard doesn’t refer all personnel at this clause, but only those who might influence the results of laboratory activities.
Aside from personnel directly working in testing/calibration/sampling activities, the requirement also covers personnel who are indirectly involved, such as technical personnel.
- personnel that perform maintenance of the equipment;
- management system personnel;
- personnel who evaluate suppliers;
- personnel who maintain the management system and internal auditing activities.
Meanwhile, there are competency requirements that must be documented:
- technical knowledge;
Moreover, procedures and records are expected for selection, supervision training, authorization, and monitoring of a personnel’s competence.
ISO/IEC 17025:2017 outlines the cases where a laboratory is expected to authorize personnel to carry out particular laboratory activities.
The requirements for facilities and environmental conditions appropriate for the laboratory activities should be documented.
The documentation should also cover conditions associated with controlling, monitoring, and recording environmental conditions.
ISO/IEC 17025:2017 establishes requirements to those environmental conditions that can impact on the results of laboratory activities.
Depending on the laboratory activities’ nature, a similar parameter can be or cannot be significant for the testing results.
For instance, the relative humidity value that is critical to textile testing, which should then be controlled, is typically not critical in the case of routine mechanical tests of plastics.
Measures to control facilities may cover:
- access to and use of areas impacting laboratory activities;
- deterrence of impurity and effective area separation, as well as facilities or sites outside the permanent control of a laboratory.
Furthermore, ISO/IEC 17025:2017 requires a procedure for handling, transport, storage, use, and planned maintenance of equipment.
There are equipment requirements that can obtain correct results during laboratory activities:
- reference data;
- reference materials;
- measurement standards;
- auxiliary apparatus
Besides, the tool or equipment should attain the required measurement uncertainty or measurement accuracy.
As a result, ISO/IEC 17025:2017 is putting a great emphasis on metrological traceability issues.
Likewise, the standard includes guidance on how to create and exhibit metrological traceability.
The clause also elaborates on the requirements concerning the control of and communication with, external organizations offering products and services that impact affecting laboratory activities.
Moreover, procedure and records are required to define, review, and approve:
- the laboratory’s requirements for externally provided products and services;
- creating the criteria for evaluation, selection, monitoring of performance, as well as a re-evaluation of the external providers.
Clause 7 – Process Requirements of ISO/IEC 17025:2017
Clause 7 has deployed process requirements as follows:
7.1 Review of requests, tenders, and contracts
ISO/IEC 17025:2017 requires the need to address issues like:
- level of understanding of requirements;
- laboratory’s competence and resources to meet the requirements;
- application of suitable control over external providers;
- selection of fitting methods to fulfill the requirements of customers.
A laboratory is expected to notify customers when the necessary testing/calibration/sampling method is deemed outdated or unfitting.
When there’s a required statement of conformity to a standard or specification, the selected decision rule must be communicated to, and agreed with, the customer.
Additionally, a laboratory must apply a contract review for any modifications in the contract, tender, or request. Relative review records are also required.
7.2 Selection, verification, and validation of methods
ISO/IEC 17025:2017 describes the word ‘method’ as a way to classify the sampling procedure, calibration method, and testing/measurement procedure.
It is expected that a laboratory can guarantee it uses the latest valid version of a method, except when it’s impossible or inappropriate to do so.
Methods include methods published by:
– regional standards;
– national standards;
– international standards;
– relevant scientific texts or journals;
– reputable technical organizations;
– manufacturer of the equipment;
Deviations from methods shall only happen if the nonconformity has been documented, technically justified, authorized, and accepted by the customer.
Laboratory-developed methods, modified standard methods, and non-standard methods are expected to be validated. A laboratory should also preserve relevant records.
The requirements found in this clause apply to laboratories that conduct sampling activities for testing and calibration laboratories which are responsible also for sampling.
A sampling method and a sampling plan should be accessible and instigated when the laboratory executes sampling of products, materials, or substances for subsequent testing or calibration.
Lastly, sampling data records should be kept per standard requirements.
7.4 Handling of test or calibration items
A laboratory should draft a procedure for the transportation, receipt, handling, protection, storage, preservation, and return or dumping of test or calibration items.
This should also include a system for the identification of test or calibration items.
Then, a laboratory should record deviations from specified conditions, Meanwhile, the customer should be consulted for the next steps.
If some items have to be stored or conditioned under certain environmental conditions, these conditions shall be preserved, checked, and recorded.
7.5 Technical records
ISO/IEC 17025:2017 expects a laboratory to comply with requirements in maintaining technical records. This is to guarantee the traceability of laboratory activities and to provide details for possible decision making.
The technical records are expected to contain the results, reports, and adequate data.
The record should be able to assist in categorizing matters impacting the measurement result and its measurement uncertainty.
Also, it should allow the recurrence of a laboratory activity, if necessary, by giving traceability to former versions or new observations, if amended.