Template:LIMSpec/Instrument and equipment management - Revision history

Shawndouglas: 10.11

2022-12-14T21:28:00Z

10.11

← Older revision		Revision as of 21:28, 14 December 2022
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	[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://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2]<br />		[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<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 />
	[https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.7.1]<br />		[https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.7.1]<br />

Shawndouglas: 10.15

2022-12-14T21:26:14Z

10.15

← Older revision		Revision as of 21:26, 14 December 2022
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	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4–5]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4–5]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.13]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4]<br />
	[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />		[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />

Shawndouglas: 10.15

2022-12-14T19:56:35Z

10.15

← Older revision		Revision as of 19:56, 14 December 2022
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	[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.4.2]<br />		[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.4.2]<br />
	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.1.4]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.4.4–5]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4]<br />
	[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />		[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />

Shawndouglas: 10.9

2022-12-14T19:53:02Z

10.9

← Older revision		Revision as of 19:53, 14 December 2022
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	[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.4.3]<br />		[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.4.3]<br />
	[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 6.4.4]<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://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />		[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />

Shawndouglas: Updated for food and bev update

2022-12-01T20:37:25Z

Updated for food and bev update

Show changes

Shawndouglas: Typo 10.7

2022-11-19T23:28:42Z

Typo 10.7

← Older revision		Revision as of 23:28, 19 November 2022
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	[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.5]<br />		[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 13.5]<br />
	[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.23]		[https://extranet.who.int/pqweb/medicines/who-technical-report-series 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 include days, weeks, months, and years.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|

Shawndouglas: Updated for 2022.

2022-05-05T20:28:47Z

Updated for 2022.

Show changes

Shawndouglas: Fixed broken URLs

2021-01-27T21:01:31Z

Fixed broken URLs

Shawndouglas at 17:29, 30 December 2020

2020-12-30T17:29:38Z

← Older revision		Revision as of 17:29, 30 December 2020
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	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-11]		\| style="padding:5px; width:500px;" \|[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-3-11]
	\| style="background-color:white;" \|'''10.12''' The system shall support the use of predefined intervals when calculating ~~Instrument~~ event dates.		\| style="background-color:white;" \|'''10.12''' The system shall support the use of predefined intervals when calculating instrument event dates.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|

Shawndouglas: Formatting fix

2020-12-17T22:28:38Z

Formatting fix

← Older revision		Revision as of 22:28, 17 December 2020
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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/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2C.3.7]		[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx 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]		[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 />
	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]		[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 4.2]

← Older revision		Revision as of 21:01, 27 January 2021
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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/~~Policies/Pages/default.aspx~~ AIHA-LAP Policies 2018 2C.3.7–2C.3.10]<br />		[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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 13.5]<br />		[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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 16.23]		[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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 16.23]		[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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 13.10]		[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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 16.23]		[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/~~Policies/Pages/default.aspx~~ AIHA-LAP Policies 2018 2C.3.7]<br />		[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/~~Policies/Pages/default.aspx~~ AIHA-LAP Policies 2018 2C.3.7–2C.3.10]<br />		[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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 15.46]<br />		[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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 16.23]		[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.
	\|-		\|-
	\|}		\|}
	\|}		\|}