This the fourth post about the transition to ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, the global standard for calibration and testing laboratories.
In our first post on the ISO/IEC 17025:2017 transition, we gave an overview. In the second post, we discussed clauses 3 through 5 of ISO/IEC 17025:2017, covering terms and definitions, general requirements, and structural requirements. Post number three focused on resource requirements detailed in clause 6 of ISO/IEC 17025:2017. This post discusses process requirements.
Clause 7 – Process Requirements
A procedure for contract review is required to address issues such as the level of understanding of requirements; laboratory’s capability and resources to meet requirements; implementation of appropriate control over external providers used (if any); and selection of appropriate methods to meet customer requirements. The laboratory shall inform the customer when the required testing, calibration, and/or sampling method is considered inappropriate or out of date.
When a statement of conformity to a specification or standard is required, the decision rule (which specifies pass/fail criteria) selected is to be communicated to and agreed with the customer.
A contract review procedure is to be applied for any changes in the contract, tender, or request. Related contract review records are required, including changes during the contract.
The term “method” is used to identify calibration method, testing or measurement procedure, and/or sampling procedure. The laboratory is expected to ensure that it uses the latest valid version of a method, unless it is not appropriate or possible to do so (e.g., a specific version of a method is defined in contract for historical comparison of data). Methods used can include methods published in international, regional, or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment or laboratory-developed or laboratory-modified methods. The laboratory is to verify that it can properly perform selected methods. Deviations from methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer. Non-standard methods, laboratory-developed methods, and modified standard methods are required to be validated, and relevant records are to be maintained.
The requirements related to sampling apply to laboratories that perform only sampling activities, and for testing and calibration laboratories that also are responsible for sampling. When the laboratory carries out sampling of substances, materials, or products for subsequent testing or calibration a sampling plan and sampling method are expected to be available and implemented. Records of sampling data are to be retained.
A procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items is required. The laboratory must have a system for identification of test or calibration items. Deviations from specified conditions are expected to be recorded and the customer consulted. If items must be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored, and recorded.
Requirements on retention of technical records are in place to ensure two functions. The first is the ability to reconstruct laboratory activities. The second is to provide information for potential decision making. Technical records are related to many laboratory functions. They are to contain a summary of laboratory activities with sufficient information to facilitate, identification of factors affecting the measurement result, and its associated measurement uncertainty. They also are to aid in the repetition of the laboratory activity if required, providing traceability to previous versions or to original observations if amended. Technical records include a copy of the report issued to the customer.
Laboratories are expected to evaluate measurement uncertainty, considering all contributions of significance, including those arising from sampling. For testing methods, where the measurement uncertainty of the results has been established and verified, there is no need to evaluate measurement uncertainty for each result. The laboratory must be able to demonstrate that the critical influencing factors are under control.
A procedure and records are required for monitoring the validity of results, which shall include where appropriate use of reference materials or QC materials; use of alternative traceable instrumentation; functional checks; use of standards with control charts; intermediate checks; replicate tests or calibrations; retesting or recalibration; correlation of results; review of reported results; intra-laboratory comparisons; testing of blind samples; participating in proficiency tests (PTs) and/or inter-laboratory comparisons (ILCs) among others. Such activities must be planned and reviewed.
Requirements related to reporting of results include results review and authorization as retained in the relative technical records. Common information required to be included in the test, calibration, or sampling reports is presented. In addition, specific information for test reports, calibration certificates, and reporting of sampling are specified. There are also clear requirements for reporting of statements of conformity. When a statement of conformity to a specification or standard is provided, the laboratory must document the decision rule employed, taking into account the associated level of risk (such as false accept and false reject and statistical assumptions), and apply the decision rule.
The clause related to complaints is the only process that is more prescriptive. A documented process is required for receiving, evaluating, and making decisions on complaints, and it must be available to any interested party upon request. Where possible, the outcomes of the process are to be communicated to the complainant. The outcomes of complaints are to be made by or reviewed and approved by an individual or individuals not involved in the original laboratory activities in question.
A nonconforming work procedure is required to ensure that the responsibilities and authorities for the management of nonconforming work are defined; subsequent actions are taken considering the risk levels; an evaluation is made of the significance of the nonconforming work; a decision is taken on the acceptability of the nonconforming work; the customer is notified, if possible; work is recalled, if needed; and the responsibility for authorizing the resumption of work is defined. Halting or repeating of work and withholding of reports as necessary can be considered among the required actions. Records of nonconforming work and relative actions are to be retained.
The control of data and information management clause identifies requirements for the laboratory information management system(s) used for collecting, processing, recording, reporting, storing, or retrieving data.
Next time: management system requirements in clause 8 of ISO/IEC 17025:2017.