Template:LIMSpec/Results review and verification - Revision history

Shawndouglas: Tweaks

2023-06-22T00:12:49Z

Tweaks

← Older revision		Revision as of 00:12, 22 June 2023
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	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<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]
	\| style="background-color:white;" \|'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.		\| style="background-color:white;" \|'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.
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	\| style="padding:5px; width:500px;" \|[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 4.0]<br />[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]		\| style="padding:5px; width:500px;" \|[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI AUTO15 4.0]<br />[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]
	\| style="background-color:white;" \|'''4.7''' The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.		\| style="background-color:white;" \|'''4.7''' The system's autoverification system should be able to be validated and have a rapid means to automatically or manually shut it down in the event of a problem or the need for manual changes being made to the autoverification system. The autoverification should be able to be revalidated afterwards.
	\|-		\|-
	\|}		\|}
	\|}		\|}

Shawndouglas: NIST tweak

2023-03-14T15:55:33Z

NIST tweak

← Older revision		Revision as of 15:55, 14 March 2023
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	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.1]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10(3)]		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10(3)]<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 />
	[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />		[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />

Shawndouglas: NIST tweak

2023-03-14T15:55:17Z

NIST tweak

← Older revision		Revision as of 15:55, 14 March 2023
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	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.1]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
			[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-10(3)]
	[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 />
	[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />		[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />

Shawndouglas: 4.4

2022-12-14T22:21:35Z

4.4

← Older revision		Revision as of 22:21, 14 December 2022
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	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.7.1]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<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: 4.4

2022-12-14T19:42:56Z

4.4

← Older revision		Revision as of 19:42, 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, 5.6.4]<br />		[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.6.4]<br />
	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<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

2022-12-01T19:07:27Z

Updated for food and bev update

← Older revision		Revision as of 19:07, 1 December 2022
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	[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />		[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-1]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-1]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.4]<br />
	[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />		[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
	[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br />		[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br />
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	\|-		\|-
	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (c)]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-111 21 CFR Part 111.110]<br />
	[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />		[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
	[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.9.1]<br />		[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.9.1]<br />
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	[https://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 5.9.4–5]<br />		[https://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 5.9.4–5]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-4]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-4]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.4]<br />
	[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />		[https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
	[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />		[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
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	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
	[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />		[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
			[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.6.4]<br />
			[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.6.4]<br />
	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
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	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
	[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-5]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 C-4-5]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.4]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.5]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
	[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />		[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
			[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.6.4]<br />
			[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.6.4]<br />
	[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<br />		[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]<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 2022.

2022-05-05T20:21:16Z

Updated for 2022.

Show changes

Shawndouglas: Fixed broken URL

2021-01-27T19:10:35Z

Fixed broken URL

← Older revision		Revision as of 19:10, 27 January 2021
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	[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />		[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
	[https://ec.europa.eu/~~health/sites/health~~/~~files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en~~.~~pdf~~ E.U. Commission Directive 2003/94/EC Article 9.2]<br />		[https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC Article 9.2]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
	\| style="background-color:white;" \|'''4.3''' The system shall accurately maintain a full audit trail for modified results.		\| style="background-color:white;" \|'''4.3''' The system shall accurately maintain a full audit trail for modified results.
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	[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />		[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
	[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br />		[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br />
	[[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3]<br />		[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3]<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 4.13.2.12]<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 4.13.2.12]<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 5.9.4–5]<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 5.9.4–5]<br />

Shawndouglas: Removed protection from "Template:LIMSpec/Results review and verification"

2019-09-19T22:17:37Z

Removed protection from "Template:LIMSpec/Results review and verification"

← Older revision	Revision as of 22:17, 19 September 2019
(No difference)

Shawndouglas: Protected "Template:LIMSpec/Results review and verification" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))

2019-09-19T21:25:55Z

Protected "Template:LIMSpec/Results review and verification" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))

← Older revision

Revision as of 21:25, 19 September 2019