Difference between revisions of "Template:LIMSpec/Instrument and equipment management"
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[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20]<br /> | [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20]<br /> | ||
[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1]<br /> | [http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1]<br /> | ||
[https://www.aihaaccreditedlabs.org/ | [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2C.3.7–2C.3.10]<br /> | ||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-7]<br /> | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-7]<br /> | ||
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br /> | [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br /> | ||
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[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.2]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.2]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 6]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 13.5]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 16.23] | ||
| style="background-color:white;" |'''10.7''' The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should be include days, weeks, months, and years. | | style="background-color:white;" |'''10.7''' The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should be include days, weeks, months, and years. | ||
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[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.9]<br /> | [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.5.9]<br /> | ||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-8]<br /> | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-8]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 16.23] | ||
| style="background-color:white;" |'''10.8''' The system shall provide clear alerts or notifications when an instrument nears its calibration due date. | | style="background-color:white;" |'''10.8''' The system shall provide clear alerts or notifications when an instrument nears its calibration due date. | ||
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[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.5]<br /> | [https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.5]<br /> | ||
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.9]<br /> | [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.9]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 13.10] | ||
| style="background-color:white;" |'''10.9''' The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use. | | style="background-color:white;" |'''10.9''' The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use. | ||
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[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br /> | [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.8]<br /> | ||
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, MA-2, MA-2(2), and MA-6(1)]<br /> | [https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, MA-2, MA-2(2), and MA-6(1)]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 16.23] | ||
| style="background-color:white;" |'''10.10''' The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument. | | style="background-color:white;" |'''10.10''' The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument. | ||
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[https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br /> | [https://www.law.cornell.edu/cfr/text/42/493.1255 42 CFR Part 493.1255]<br /> | ||
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.6.1–2]<br /> | [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.6.1–2]<br /> | ||
[https://www.aihaaccreditedlabs.org/ | [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2C.3.7]<br /> | ||
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br /> | [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br /> | ||
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br /> | [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br /> | ||
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[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20 and -23]<br /> | [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-20 and -23]<br /> | ||
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. F-1 and I-1]<br /> | [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. F-1 and I-1]<br /> | ||
[https://www.aihaaccreditedlabs.org/ | [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 2C.3.7–2C.3.10]<br /> | ||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-14]<br /> | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-14]<br /> | ||
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br /> | [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 7]<br /> | ||
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[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.4]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.46]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 16.23] | ||
| style="background-color:white;" |'''10.15''' The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities. | | style="background-color:white;" |'''10.15''' The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities. | ||
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