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Similaire à Guide25 vs ISO/IEC17025
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Guide25 vs ISO/IEC17025
- 1. ISO Guide 25, ISO 17025 and Optical Metrology: An Assessor’s Perspective Gene A. Zerlaut SC-International Inc. CORM 2000 Rochester, NY May 19, 2000
- 19. ISO/IEC 17025 Differences in Technical Requirements More prescriptive than Guide 25, but no new ideas. The most significant details are described in the following slides The following slides also delineate A2LA & NVLAP Calibration Program requirements
Notes de l'éditeur
- My presentation is based on the assumption that many of you are at least somewhat familiar with the requirements of ISO/IEC Guide 25. Therefore, I will neither dwell in detail on Guide 25 criteria elements, nor on the details of ISO 17025. Time simply doesn’t permit examination of either document in detail. Also, let me note that for the sake of brevity, I may often refer to these two standards as ISO documents rather than ISO/IEC 17025, or ISO/IEC Guide 25
- Rather, I will attempt to define the differences between the two standards. First, we should note that 17025 has the same title as Guide 25. Like Guide 25, 17025 applies to both testing and calibration laboratories. The last slide of the pre-printed handout (#32) is a listing of the resource documents used for my presentation. All new applicants whose applications are received after January 1, 2001 will be assessed to 17025. Renewal labs will have the option of compliance with 17025. If they choose Guide 25, they will be required to undergo surveillance for compliance to 17025 in Y2002
- The 13 requirements of Guide 25 have been split between Management and Technical Requirements sections in 17025. ISO 17025 is aligned much more closely with ISO 9001 than is Guide 25. In fact, Annex 1 is a cross reference between 17025 and 6001 Annex 2 is a set of informative (that is, non-normative) guidelines for establishing interpretations for specific testing fields . . . such as, for example, the calibration field.
- Of these 14 criteria elements, the requirements for contract review, service to the client, and preventive actions are entirely new. A number of Guide 25 requirements have been split into two or more requirements in 17025 . . accounting for the larger number of requirements. I will discuss them in greater detail later in this presentation.
- It should be noted that, like Guide 25, the sub-contracting of calibrations to outside services is covered in the criteria element dealing with purchased services and supplies (4.6). The details associated with the section of ISO 17025 that covers technical requirements will be discussed in subsequent slides.
- The most significant of these differences is the requirement that the laboratory must identify potential conflicts of interest. This new requirement is in addition to the Guide 25-type language requiring that the laboratory have arrangements to ensure that its personnel are free from external pressures that may affect the quality of their work.
- The requirement that all documentation used in the quality system must be identified in the Quality Manual effectively means that the Quality Manual should address all twenty-three (23) criteria elements of ISO/IEC 17025. This does not mean that all quality procedures and documents need to be contained in the Manual. Rather, the Quality Manual should present all quality policies, and at the same time must identify all daughter documentation. . . .whether located in separate procedures manuals or whether maintained as stand-alone documents. The Quality Manual needs to be a road map to the quality system and its documentation.
- 17025 is more prescriptive than Guide 25.
- The new requirements correspond to 10.8 of Guide 25 covering procedures for purchase, receiving and storage of consumable materials, which applies most cogently to chemistry laboratories. 17025 element 4.6 also corresponds to element 15 of Guide 25, which applies to purchased services
- One approach to meeting this requirement is to have a policy in place that addresses the informative notes to 4.7 (for example, to operate a formal client feed-back program using questionnaires after the work has been completed). With respect to specific calibration program requirements, it is certainly conceivable that either A2LA or NVLAP could recommend, or even require, that calibration laboratories accredited to ISO 17025 offer a calibration- recall service to their clients.
- The new corrective action requirements are presented in the next slide
- It should be noted that the bottom line requires that the reason, or reasons, for the non-conformity be determined, that a corrective action be selected and implemented and that it sticks!
- In addressing this issue, the laboratory must remember that preventive actions are required for quality system elements such as procedural failures (e.g., document control), as well as for its technical activities (such as equipment, calibration, tests and reports).
- The essential aspect of records retention is the need to preserve sufficient information such that [1] the test can be re-run in all details (test operator, test method, test conditions, etc.), and [2] both raw and analyzed data are retained in all the detail that is necessary for critical technical examination at any time during the entire period of retention.
- In other words, management review is defined in terms of the scope of the review process, the documentation requirements and the response to any corrective actions that are identified. The assessor must judge the appropriateness of the frequency with which the laboratory performs its management reviews. The frequency must be evaluated against the findings of non-conformities during an audit to 17025.
- There is more detail in these ISO/IEC 17025 requirements, but no radically new ideas.
- Unlike Guide 25, 17025 does not directly address the need for maintaining the training of test personnel up-to-date.
- “ Validation is the confirmation by examination and the provision of objective evidenced that the particular requirements for a specific intended use are fulfilled.” Validation may be done by one or more of the following methods, among others: - calibration using reference standard or materials - comparison of results achieved with other methods - inter-laboratory comparisons - systematic assessment of the factors influencing the result
- I will not dwell on this slide since I furnished it for information purposes.
- As both an assessor and quality consultant, I have found that one of the poorest levels of documentation observed in many test laboratories is that of maintenance and preventive maintenance procedures. Too often they are nothing more than aged, dog-eared and faded maintenance suggestions taken from their OEM’s operating instructions and manuals.
- Although there is no absolute requirement for recording the fact of inspection of incoming samples prior to testing or calibration, it is a very good practice to do so. You, as the operator of either a testing or calibration laboratory, must decide how relevant this idea is for your operation. Lack of a notation that the sample was inspected prior to testing or calibration, regardless of whether a discrepancy was noted, can come back to haunt the laboratory in third party actions.
- In point of fact, re-testing of retained samples, and re-testing of laboratory-developed secondary reference materials, samples or devices, can permit the generation of statistical quality control charts that provide a great deal of information. SQC charts that show trending, sliding averages, and frequent data outside the established control limits, can signal out-of-control conditions in advance of obtaining defective data. Contra-wise, charts that show a stable mean measurement result with random data about the mean provides a good measure of the accuracy of the measurement.
- The last item may not apply to calibration laboratories.