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articles:iso17025-2017_oe_requirements-1 [2019/09/01 09:33]
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articles:iso17025-2017_oe_requirements-1 [2019/09/01 10:28] (current)
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 |  **12** ​ | The laboratory shall have a //​**procedure**//​ for the transportation,​ receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer. Precautions shall be taken to avoid deterioration,​ contamination,​ loss or damage to the item during handling, transporting,​ storing/​waiting,​ and preparation for testing or calibration. Handling instructions provided with the item shall be followed.| ​ 7.4.1  | |  **12** ​ | The laboratory shall have a //​**procedure**//​ for the transportation,​ receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer. Precautions shall be taken to avoid deterioration,​ contamination,​ loss or damage to the item during handling, transporting,​ storing/​waiting,​ and preparation for testing or calibration. Handling instructions provided with the item shall be followed.| ​ 7.4.1  |
 |  **13** ​ | The laboratory shall have a //​**procedure**//​ for monitoring the validity of results. The resulting data shall be recorded in such a way that trends are detectable and, where practicable,​ statistical techniques shall be applied to review the results. This monitoring shall be planned and reviewed and shall include, where appropriate,​ but not be limited to: \\ a) use of reference materials or quality control materials; \\ b) use of alternative instrumentation that has been calibrated to provide traceable results; \\ c) functional check(s) of measuring and testing equipment; \\ d) use of check or working standards with control charts, where applicable; \\ e) intermediate checks on measuring equipment; \\ f) replicate tests or calibrations using the same or different methods; \\ g) retesting or recalibration of retained items; \\ h) correlation of results for different characteristics of an item; \\ i) review of reported results; \\ j) intralaboratory comparisons;​ \\ k) testing of blind sample(s). |  7.7.1  | |  **13** ​ | The laboratory shall have a //​**procedure**//​ for monitoring the validity of results. The resulting data shall be recorded in such a way that trends are detectable and, where practicable,​ statistical techniques shall be applied to review the results. This monitoring shall be planned and reviewed and shall include, where appropriate,​ but not be limited to: \\ a) use of reference materials or quality control materials; \\ b) use of alternative instrumentation that has been calibrated to provide traceable results; \\ c) functional check(s) of measuring and testing equipment; \\ d) use of check or working standards with control charts, where applicable; \\ e) intermediate checks on measuring equipment; \\ f) replicate tests or calibrations using the same or different methods; \\ g) retesting or recalibration of retained items; \\ h) correlation of results for different characteristics of an item; \\ i) review of reported results; \\ j) intralaboratory comparisons;​ \\ k) testing of blind sample(s). |  7.7.1  |
-|  **14** ​ | The laboratory shall have a //​**documented**//​ process to receive, evaluate and make decisions on complaints. |  7.9.1  |+|  **14** ​ | The laboratory shall have a //​**documented**//​ process to receive, evaluate and make decisions on complaints. ​ \\ <wrap hi>​**[While the word //​procedure//​ is not used here, this is typically interpreted as the intent.]**</​wrap> ​|  7.9.1  |
 |  **15** ​ | The laboratory shall have a //​**procedure**//​ that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The //​**procedure**//​ shall ensure that: \\ a) the responsibilities and authorities for the management of nonconforming work are defined; \\ b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory; \\ c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results; \\ d) a decision is taken on the acceptability of the nonconforming work; \\ e) where necessary, the customer is notified and work is recalled; \\ f) the responsibility for authorizing the resumption of work is defined.| ​ 7.10.1 ​ | |  **15** ​ | The laboratory shall have a //​**procedure**//​ that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The //​**procedure**//​ shall ensure that: \\ a) the responsibilities and authorities for the management of nonconforming work are defined; \\ b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory; \\ c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results; \\ d) a decision is taken on the acceptability of the nonconforming work; \\ e) where necessary, the customer is notified and work is recalled; \\ f) the responsibility for authorizing the resumption of work is defined.| ​ 7.10.1 ​ |
-|  ​**16**  | Laboratory management shall establish, //​**document**//,​ and maintain policies and objectives for the fulfilment of the purposes of this document and shall ensure that the policies and objectives are acknowledged and implemented at all levels of the laboratory organization. \\ <wrap hi>​**[While not specifically required, this is typically accomplished through a Quality Manual.]**</​wrap>​ |  8.2.1  |+|  16  | Laboratory management shall establish, //​**document**//,​ and maintain policies and objectives for the fulfilment of the purposes of this document and shall ensure that the policies and objectives are acknowledged and implemented at all levels of the laboratory organization. \\ <wrap hi>​**[While not specifically required, this is typically accomplished through a Quality Manual.]**</​wrap>​ |  8.2.1  |
  
  
-<note tip>**# 1 ** \\ For information on how to create/​craft the language of the "​__range of laboratory activities__"​ reference ANAB Administrative Process Rule: \\ • [[https://​anab.qualtraxcloud.com/​ShowDocument.aspx?​ID=9162|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 CALIBRATION LABORATORIES]] \\ • [[https://​anab.qualtraxcloud.com/​ShowDocument.aspx?​ID=9161|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 TESTING LABORATORIES]]</​note>​+<note tip>**# 1 ** \\ For information on how to create/​craft the language of the "​__range of laboratory activities__"​ reference ANAB Administrative Process Rule: \\ • [[https://​anab.qualtraxcloud.com/​ShowDocument.aspx?​ID=9162|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 CALIBRATION ​LABORATORIES]] \\ • [[https://​anab.qualtraxcloud.com/​ShowDocument.aspx?​ID=12602|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 DIMENSIONAL MEASUREMENT ​LABORATORIES]] \\ • [[https://​anab.qualtraxcloud.com/​ShowDocument.aspx?​ID=9161|PREPARING A DRAFT SCOPE OF ACCREDITATION FOR ISO/IEC 17025 TESTING LABORATORIES]]</​note>​