Difference between revisions of "Template:LIMSpec/Resource management"

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[https://www.law.cornell.edu/cfr/text/9/2.32 9 CFR Part 2.32]<br />
[https://www.law.cornell.edu/cfr/text/10/20.2103 10 CFR Part 20.2103]<br />
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1150]<br />
[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-1 21 CFR Part 1.1152 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-110 21 CFR Part 110.10 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-120 21 CFR Part 120.12]<br />
[https://www.law.cornell.edu/cfr/text/21/part-123 21 CFR Part 123.10]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (m)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (m)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-1)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-1)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (j)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (j)]<br />
[https://www.law.cornell.edu/cfr/text/40/262.207 40 CFR Part 262.207]<br />
[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.2.3]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.7]<br />
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories B3–B5]<br />
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.3.1]<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://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AT-4]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.3]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.1]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-3 and -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.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020 OSHA 1910.1020 (throughout)]<br />
[https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200 OSHA 1910.1200(b)(3) and (h)]<br />
[https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450 (throughout)]<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.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.2]<br />
[https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 8.1]
   | style="background-color:white;" |'''8.1''' The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.
   | style="background-color:white;" |'''8.1''' The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.
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[https://www.law.cornell.edu/cfr/text/21/820.198 21 CFR Part 820.198]<br />
[https://www.law.cornell.edu/cfr/text/21/820.198 21 CFR Part 820.198]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1233 42 CFR Part 493.1233]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1233 42 CFR Part 493.1233]<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 13]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.10.1–2]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 2.1 (j)]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 5.0]
[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 21]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.8]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.8]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.9]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.10]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (j)]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
   | style="background-color:white;" |'''8.2''' The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.
   | style="background-color:white;" |'''8.2''' The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.
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[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15]<br />
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15]<br />
[https://www.law.cornell.edu/cfr/text/21/part-120 21 CFR Part 120.12]<br />
[https://www.law.cornell.edu/cfr/text/21/part-123 21 CFR Part 123.10]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<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 5.9.3.3]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-1]<br />
[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<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 5.9.3.3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-1]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.1]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AT-2 and AT-3]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CP-3]<br />
[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-2]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.3]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2 and AT-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<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.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2–3]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2–3]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 10]
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
   | style="background-color:white;" |'''8.3''' The system shall allow training sessions to be scheduled for personnel.
   | style="background-color:white;" |'''8.3''' The system shall allow training sessions and reviews to be scheduled for personnel.
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   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br />
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<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 5.2.7]<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 5.2.7]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-2]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-2]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9]
   | style="background-color:white;" |'''8.4''' The system should provide access to relevant training materials to personnel attending training sessions.
   | style="background-color:white;" |'''8.4''' The system should provide access to relevant training materials to personnel attending training sessions.
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   | style="padding:5px; width:500px;" |
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br />
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br />
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-110 21 CFR Part 110.10 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/part-120 21 CFR Part 120.12]<br />
[https://www.law.cornell.edu/cfr/text/21/part-123 21 CFR Part 123.10]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<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 />
[https://www.law.cornell.edu/cfr/text/40/262.207 40 CFR Part 262.207]<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 5.2.1.1–3]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<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 5.2.6.2]<br />
[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C6.3]<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 5.9.3.3 and 5.9.3.5]<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 4.13.2.12]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-3]<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 5.2.1.1–3]<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 5.2.6.2]<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 5.9.3.3 and 5.9.3.5]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-3]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br />
[https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<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 7.4]<br />
[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 7.4]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.3]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.3]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AT-2–AT-4]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2–AT-4]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CP-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-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.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9]<br />
[https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 2.1 (e)]<br />
[https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.2]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 9.4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (e)]<br />
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 10]
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 9.4]<br />
[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
   | style="background-color:white;" |'''8.5''' The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.
   | style="background-color:white;" |'''8.5''' The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-4]
   | style="padding:5px; width:500px;" |
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-4]<br />
[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.3]<br />
[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.3]
   | style="background-color:white;" |'''8.6''' The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.
   | style="background-color:white;" |'''8.6''' The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-5]<br />
   | style="padding:5px; width:500px;" |
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AT-2 and AT-3]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-5]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, CP-3]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br />
[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-2]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2 and AT-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br />
[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br />
[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9]
   | style="background-color:white;" |'''8.7''' The system should be able to produce a training matrix of personnel.
   | style="background-color:white;" |'''8.7''' The system should be able to produce a training matrix of personnel.
  |-  
  |-  
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
   | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
[https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br />
[https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br />
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br />
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br />
[https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br />
[https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1150]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br />
[https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br />
Line 110: Line 199:
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 310.25]<br />
[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 381.94]<br />
[https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 (various parts)]<br />
[https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 (various parts)]<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 />
[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 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 5.2.1.1–3]<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 5.2.1.1–3]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-5]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-5]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-6]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-6]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-6]<br />
[https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-6]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.3–4]<br />
[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.4]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br />
Line 132: Line 226:
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.5]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.5]<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 />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<br />
[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]
   | style="background-color:white;" |'''8.8''' The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
   | style="background-color:white;" |'''8.8''' The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
  |-  
  |-  
|}
|}
|}
|}

Latest revision as of 22:17, 22 June 2023

Regulation, Specification, or Guidance Requirement

9 CFR Part 2.32
10 CFR Part 20.2103
21 CFR Part 1.1150
21 CFR Part 1.1152 (c)
21 CFR Part 1.1152 (d)
21 CFR Part 110.10 (c)
21 CFR Part 120.12
21 CFR Part 123.10
29 CFR Part 1910.120
29 CFR Part 1910.134 (m)
29 CFR Part 1910.1030 (h-1)
29 CFR Part 1910.1450 (j)
40 CFR Part 262.207
A2LA C211 4.13.2.3
A2LA C223 5.2
A2LA C223 5.7
ACMG Technical Standards for Clinical Genetics Laboratories B3–B5
APHL 2019 LIS Project Management Guidebook
BRC GSFS, Issue 8, 7.1.x
BRC GSFS, Issue 8, 7.3.1
CAP Laboratory Accreditation Manual
CJIS Security Policy 5.2.3
EPA ERLN Laboratory Requirements 4.2.4.1
EPA QA/G-5 2.1.8
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1
GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7
IFS Food 7, Part 2, 3.1
IFS Food 7, Part 2, 3.3
IFS PACsecure 2, Part 2, 3.1
IFS PACsecure 2, Part 2, 3.3
NIST 800-53, Rev. 5, AT-3 and -4
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
OSHA 1910.1020 (throughout)
OSHA 1910.1200(b)(3) and (h)
OSHA 1910.1450 (throughout)
PFP Human and Animal Food Testing Laboratories Best Practices Manual
SQF FSC 9, Food Manufacturing, Part B, 2.9
SQF FSC 9, Pet Food Manufacturing, Part B, 2.9
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)
USDA Administrative Procedures for the PDP 6.1
USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3
WADA International Standard for Laboratories (ISL) 5.2.2
WHO Technical Report Series, #996, Annex 5, 8.1

8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.

21 CFR Part 820.198
42 CFR Part 493.1233
BRC GSFS, Issue 8, 3.10.1–2
E.U. Commission Directive 2003/94/EC Article 13
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21
IFS Food 7, Part 2, 5.8
IFS PACsecure 2, Part 2, 5.8
ISO/IEC 17025:2017 7.9
TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)
WADA International Standard for Laboratories (ISL) 5.3.10
WHO Technical Report Series, #986, Annex 2, 2.1 (j)
WHO Technical Report Series, #986, Annex 2, 5.0

8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.

5 CFR Part 930.301
7 CFR Part 331.15
9 CFR Part 121.15
21 CFR Part 120.12
21 CFR Part 123.10
21 CFR Part 211.25
29 CFR Part 1910.1450 (f)
42 CFR Part 73.15
A2LA C223 5.2
APHL 2019 LIS Project Management Guidebook
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3
ASTM E1578-18 E-1-1
BRC GSFS, Issue 8, 7.1.x
CJIS Security Policy 5.2.1
EPA ERLN Laboratory Requirements 4.2.4.1
FDA Hazard Analysis Critical Control Point Guidelines
GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1
GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7
IFS Food 7, Part 2, 3.3
IFS PACsecure 2, Part 2, 3.3
NIST 800-53, Rev. 5, AT-2 and AT-3
NIST 800-53, Rev. 5, CP-3
NIST 800-53, Rev. 5, IR-2
PFP Human and Animal Food Testing Laboratories Best Practices Manual
SQF FSC 9, Food Manufacturing, Part B, 2.9
SQF FSC 9, Pet Food Manufacturing, Part B, 2.9
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)
USDA Sampling Procedures for PDP 6.1.2–3
WHO Technical Report Series, #986, Annex 2, 10

8.3 The system shall allow training sessions and reviews to be scheduled for personnel.

5 CFR Part 930.301
29 CFR Part 1910.1450 (f)
ABFT Accreditation Manual Sec. B
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7
ASTM E1578-18 E-1-2
BRC GSFS, Issue 8, 7.1.x
FDA Hazard Analysis Critical Control Point Guidelines
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
SQF FSC 9, Food Manufacturing, Part B, 2.9
SQF FSC 9, Pet Food Manufacturing, Part B, 2.9
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9

8.4 The system should provide access to relevant training materials to personnel attending training sessions.

5 CFR Part 930.301
21 CFR Part 1.1152 (d)
21 CFR Part 110.10 (c)
21 CFR Part 120.12
21 CFR Part 123.10
29 CFR Part 1910.1450 (f)
40 CFR Part 262.207
A2LA C223 5.2
ACMG Technical Standards for Clinical Genetics Laboratories C6.3
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5
ASTM E1578-18 E-1-3
BRC GSFS, Issue 8, 7.1.x
CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition
CJIS Security Policy 5.2.3
EPA ERLN Laboratory Requirements 4.2.4.1
EPA QA/G-5 2.1.8
E.U. Commission Directive 2003/94/EC Article 7.4
FDA Hazard Analysis Critical Control Point Guidelines
IFS Food 7, Part 2, 3.3
IFS PACsecure 2, Part 2, 3.3
ISO 15189:2012 5.1.9
NIST 800-53, Rev. 5, AT-2–AT-4
NIST 800-53, Rev. 5, CP-3
NIST 800-53, Rev. 5, IR-2
NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
SQF FSC 9, Food Manufacturing, Part B, 2.9
SQF FSC 9, Pet Food Manufacturing, Part B, 2.9
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9
TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)
USDA Administrative Procedures for the PDP 6.1
USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e
USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3
WADA International Standard for Laboratories (ISL) 5.2.2
WHO Technical Report Series, #986, Annex 2, 2.1 (e)
WHO Technical Report Series, #986, Annex 2, 9.4
WHO Technical Report Series, #986, Annex 2, 10

8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.

ABFT Accreditation Manual Sec. B
ASTM E1578-18 E-1-4
IFS Food 7, Part 2, 3.3
IFS PACsecure 2, Part 2, 3.3

8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.

ASTM E1578-18 E-1-5
BRC GSFS, Issue 8, 7.1.x
NIST 800-53, Rev. 5, AT-2 and AT-3
NIST 800-53, Rev. 5, CP-3
NIST 800-53, Rev. 5, IR-2
SQF FSC 9, Food Manufacturing, Part B, 2.9
SQF FSC 9, Pet Food Manufacturing, Part B, 2.9
SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9

8.7 The system should be able to produce a training matrix of personnel.

7 CFR Part 331.15
9 CFR Part 121.10
9 CFR Part 121.15
21 CFR Part 11.10 (i)
21 CFR Part 58.29
21 CFR Part 1.1150
21 CFR Part 211.25
21 CFR Part 225.10
21 CFR Part 226.10
21 CFR Part 226.40
21 CFR Part 820.25
29 CFR Part 1910.1030 (g-2)
29 CFR Part 1910.1030 (h-2)
29 CFR Part 1910.1200 (h)
29 CFR Part 1910.1450 (e)
42 CFR Part 73.10
42 CFR Part 73.15
42 CFR Part 493.43 (c)
42 CFR Part 493.1235
45 CFR Part 164.308
45 CFR Part 164.530
61 FR 38806, 9 CFR Part 310.25
61 FR 38806, 9 CFR Part 381.94
A2LA C223 5.2
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6
AAVLD Requirements for an AVMDL Sec. 5.2
AAVLD Requirements for an AVMDL Sec. 5.4.2.2
AAVLD Requirements for an AVMDL Appendix 1
ABFT Accreditation Manual Sec. B
AIHA-LAP Policies 2022 (various parts)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASTM E1578-18 C-3-5
ASTM E1578-18 D-1-6
ASTM E1578-18 E-1-6
BRC GSFS, Issue 8, 5.6.2.3–4
BRC GSFS, Issue 8, 9.3.4
E.U. Annex 11-2
EPA 815-R-05-004 Chap. III, Sec. 10 and 17
EPA 815-R-05-004 Chap. IV, Sec. 1
EPA QA/G-5 2.1.8
ISO 15189:2012 4.1.2.1
ISO 15189:2012 5.1.6
ISO 15189:2012 5.1.9
ISO/IEC 17025:2017 6.2.2
ISO/IEC 17025:2017 6.2.3
ISO/IEC 17025:2017 6.2.5
ISO/IEC 17025:2017 6.2.6
OECD GLP Principles 1.1.2
USDA Administrative Procedures for the PDP 6.1

8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.