Continuing our 3-part series about the new requirements of ISO/IEC 17025 2017, this concluding post discusses the rest of the required clauses.
Before you start implementing the standard, be sure to go through all the system requirements.
We’ve also prepared toolkits at the end of this article for faster implementation.
7.6 Evaluation of Measurement Uncertainty
Testing laboratories are expected to evaluate measurement uncertainty. This should consider all significant contributions, including those coming from sampling.
ISO/IEC 17025:2017 states that for a certain method, where the measurement uncertainty of the results has been identified and confirmed, there is no need to evaluate measurement uncertainty for each result.
This is only applicable if a laboratory can show that the established critical influencing factors are under control.
On the other hand, calibration laboratories are expected to assess the measurement uncertainty for all calibrations. This should consider all essential contributions, including those arising from sampling.
7.7 Assuring the Validity of Results
ISO/IEC 17025:2017 requires a procedure and records to check the validity of results. Yet, a laboratory should first plan the review of his results when using some of the following activities:
- use of reference materials or QC materials;
- intermediate checks;
- use of alternative traceable instrumentation;
- replicate tests or calibrations;
- functional checks;
- use of standards with control charts;
- intra-laboratory comparisons;
- retesting or recalibration;
- correlation of results;
- review of reported results;
- testing of blind samples
- participation in PT’s (proficiency tests) and/or ILC’s (interlaboratory comparisons)
7.8 Reporting of Results
ISO/IEC 17025:2017 established requirements for results review and authorization as reserved in the relative technical records. Hence, laboratory activity results must be reported.
The following clauses have their designated coverage:
7.8.2 – Common data mandatory to be incorporated in the test, calibration, or sampling reports.
7.8.3 – Particular information for test reports.
7.8.4 – Calibration certificates.
7.8.5 – Reporting sampling.
7.8.6 – Reporting statements of conformity.
7.8.7 – Reporting interpretations and opinions.
7.8.8 – Amendments to reports.
ISO/IEC 17025:2017 requires a laboratory to have a documented process for receiving, evaluating, and making decisions on complaints.
This process should be accessible to any interested party upon request.
Individual(s) not involved in the original laboratory activities in question should identify, review, and approve the outcomes to be notified to the complainant.
7.10 Nonconforming work
ISO/IEC 17025:2017 expects a laboratory to apply a nonconforming work procedure to ensure that:
- the authorities and responsibilities for the management of nonconforming work are established;
- subsequent actions are taken considering the risk levels;
- an evaluation is made of the significance of the nonconforming work;
- a decision is made on the satisfactoriness of the nonconforming work;
- work is recalled, if necessary;
- the responsibility for approving the recommencement of work is distinct;
- stopping or repeating work and withholding reports, if necessary.
ISO/IEC 17025:2017 expects laboratories to keep records of non-conforming work and relative actions.
7.11 Control of Data – Information Management
This clause covers requirements for the laboratory information management system(s) used for the accumulation, handling, recording, reporting, storage, and recovery of data.
Clause 8 – Management System Requirements
There are two options a laboratory can choose from in implementing a management system.
- Listing the minimum requirements for the implementation of a laboratory’s management system. This option incorporates some ISO 9001 requirements. Those ISO 9001 requirements are important to the scope of laboratory activities that are covered by the management system.
- Creating and maintaining a management system following the requirements of ISO 9001. Laboratories that use this option will function under ISO 9001. A laboratory’s conformity to the requirements of ISO 9001 does not, by itself, exhibit the competence of the laboratory to release technically valid data and results. This is obtained only through compliance with ISO/IEC 17025.
Clause 8 shows that the requirements for documentation have been substantially deducted.
- Management system policies and objectives (8.2.1)
- Analysis of customer feedback (8.6.2)
- Corrective actions, non-conformities related records (8.7.3)
- Internal audit and results records (8.8.2)
- Management review input and output record (8.9.2)
Note that there are no requirements for documented procedures associated with management system activities mentioned in clause 8.
Besides, there is no requirement for a Quality Manual.
Due to the introduction of risk-based thinking in ISO/IEC 17025:2017, some reduction in prescriptive requirements and their replacement by performance-based requirements became possible.
Furthermore, the recent version of the standard added Clause 8.5, which covers actions to address risks and opportunities.
Clause 8.5 requires a laboratory to consider the risks and opportunities associated with the laboratory activities.
These activities are described throughout the standard and include:
- risks related to impartiality (4.1.4);
- statements of conformity (7.8.6);
- nonconforming work (7.10.1);
- corrective actions (8.7.1)
Nevertheless, ISO/IEC 17025:2017 doesn’t require a particular or formal method for risk management or a documented risk management process.
You can check on the Risk Management – Principles and Guidelines found in ISO 31000.
The Transition of ISO/IEC 17025:2017
There’s a 3-year transition period following the publication of the standard’s final version.
Accreditation bodies must have all laboratories assessed to the ISO/IEC 17025:2017 by the end of 2020.
Thus, QSE Academy urges laboratories to plan and begin the transition process as early as now.
Here are the transition steps:
- Agree on the overall timeline.
- Train the lab personnel who will be responsible for transition and implementation.
- Study how to interpret and implement the requirements of the new standard.
- Perform a gap analysis between the current quality system and the revised standard’s requirements.
- Update documentation of the management system, as well as present procedures and policies.
- Reduce management system documentation.
- Develop a communication plan and a training plan for laboratory personnel.
- Implement the revised management system.