|
|
(77 intermediate revisions by the same user not shown) |
Line 1: |
Line 1: |
| {|
| | <div class="nonumtoc">__TOC__</div> |
| | STYLE="vertical-align:top;"|
| | {{ombox |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" | | | type = notice |
| |-
| | | style = width: 960px; |
| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| | | text = This is sublevel8 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> |
| |-
| | }} |
| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| | |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
| | ==Sandbox begins below== |
| |-
| | Material testing can focus on specific industries (e.g., automotive, construction, and pharmaceutical), products (e.g., car seats, asphalt, and medical devices), or raw materials (e.g., steel, gravel, and zirconia ceramic). |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-1]
| | |
| | style="background-color:white;" |'''1.1''' The system should allow for sample registration prior to (e.g., preregistration) or after (e.g., registration) physical sample collection.
| | About chemical testing of raw materials https://a2la.org/accreditation/chemical-testing/ |
| |-
| | |
| | style="padding:5px; width:350px;" |
| | Material testing domains: |
| [https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />
| | * Aerospace |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
| | **Adhesives |
| [https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br /> | | **Composites |
| [https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br />
| | **Fasteners |
| [https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br />
| | **Paints and primers |
| [https://www.law.cornell.edu/cfr/text/21/606.121 21 CFR Part 606.121 (c–i)]<br />
| | **Sealants |
| [https://www.law.cornell.edu/cfr/text/21/606.140 21 CFR Part 606.140 (c)]<br />
| | **Etc. |
| [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br />
| | *Automotive |
| [https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e1-6)]<br />
| | **Adhesives |
| [https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
| | **Coatings |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br />
| | **Foams |
| [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
| | **Lighting and high-visibility solutions |
| [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.1.6]<br />
| | **Plastics |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-2]<br /> | | **Seating |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.2]<br />
| | **Etc. |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br /> | | *Carbon |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br /> | | **Activated carbon |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 15]<br />[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
| | **Coal tar |
| [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 5.8.6)]<br />
| | **Etc. |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.6]<br />
| | *Coatings, linings, and sealants |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
| | **Ceramic coatings |
| | style="background-color:white;" |'''1.2''' The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
| | **Metal coatings |
| |-
| | **Pipe linings |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/45/162.410 45 CFR Part 162.410]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.1]
| | **Thermal sprays |
| | style="background-color:white;" |'''1.3''' The system shall provide a means to assign unique identifiers such as a National Provider Identifier (NPI) or Originating Agency Identifier (ORI) to the enacting entity and any subcontracted entity. The unique identifier should be able to appear on necessary records, documents, and reports referencing those entities.
| | **Etc. |
| |-
| | *Construction and engineering |
| | style="padding:5px; width:350px;" |[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-1-3]
| | **Asphalt |
| | style="background-color:white;" |'''1.4''' The system should provide a means for automatically registering samples in the system using any number of triggers such as dates, times, web requests, and intra-system methods like APIs and web services.
| | **Brick and tile |
| |-
| | **Fasteners |
| | style="padding:5px; width:350px;" |
| | **Fenestration and glazing products (i.e., windows, doors, glass) |
| [https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<br />
| | **Geosynthetics |
| [https://www.law.cornell.edu/cfr/text/40/262.18 40 CFR Part 262.18]<br />
| | **Plumbing |
| [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 C2.1]<br />
| | **Soil |
| [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br />
| | **Etc. |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-4]<br />
| | * Insulation, foam, and composites |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.3]
| | **Fiberglass |
| | style="background-color:white;" |'''1.5''' The system should permit unique metadata like lot number, patient number, family identifier, client or patient demographics, sampling point, random selection process used, and industry-specific items (like EPA identification number) to be included during registration.
| | **Flexible and laminate urethane foam composite |
| |-
| | **Polyester resins |
| | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-5]
| | **Etc. |
| | style="background-color:white;" |'''1.6''' The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
| | *Lubricants and thickeners |
| |-
| | **Metallic stearates |
| | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-6]
| | **Powdered metal |
| | style="background-color:white;" |'''1.7''' The system should offer safety information related to a submitted sample upon registration that is relevant to the lab's location and industry.
| | **Pre-formed grease thickeners |
| |-
| | **Etc. |
| | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-7]
| | * Medical devices |
| | style="background-color:white;" |'''1.8''' The system should support the creation and use of predefined metadata templates, as well as ad-hoc, single, and multiple samples.
| | **Ceramics |
| |-
| | **Metals |
| | style="padding:5px; width:350px;" |
| | **Screws |
| [https://www.law.cornell.edu/cfr/text/7/91.19 7 CFR Part 91.19]<br />
| | **Etc. |
| [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
| | *Metals |
| [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
| | **Aluminum |
| [https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.105 (c)]<br />
| | **Castings |
| [https://www.law.cornell.edu/cfr/text/21/58.105 21 CFR Part 58.195]<br />
| | **Copper |
| [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
| | **Rebar |
| [https://www.law.cornell.edu/cfr/text/21/211.170 21 CFR Part 211.170]<br />
| | **Steel |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| | **Tubing |
| [https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (d)]<br />
| | **Welds |
| [https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br />
| | **Zinc |
| [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
| | **Etc. |
| [https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105]<br />
| | * Packaging and labeling |
| [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
| | **Cardboard |
| [https://www.law.cornell.edu/cfr/text/42/493.1242 42 CFR Part 493.1242]<br />
| | **Label adhesives |
| [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274 (f)]<br />
| | **Pharmaceutical packaging |
| [https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
| | **Sterile barrier materials |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.2–3]<br />
| | **Etc. |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.7.1.2]<br />
| | * Paints and oils |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D]<br />
| | **Interior/Exterior paints |
| [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 C2]<br />
| | **Organic coatings |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-8]<br />
| | **Paint on parts |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<br />
| | **Transformer oil |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6 and 8]<br />
| | **Etc. |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br />
| | * Paper |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1000PUE.txt EPA 815-R-05-004 Supplement 1]<br />
| | **Cellulose paper tape |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />
| | **Crepe paper and tubes |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10–11]<br />
| | **Kraft paper |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.7.1–6]<br />
| | **Pressboard |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]<br />
| | **Etc. |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 11.4]<br />
| | *Polymers and plastics |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.2]<br />
| | **Biopolymers |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
| | **Condoms and gloves |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
| | **Payment cards |
| [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 />
| | **O-rings |
| [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 5.8.6)]<br />
| | **[https://www.sciencedirect.com/science/article/pii/S1751616121005105 Silicone-based biological tissue mimics] |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1 and 5.1.13]<br />
| | **Thermoplastic resins |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.1]<br />
| | **Etc. |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11 and 17.21]
| | * Raw materials |
| | style="background-color:white;" |'''1.9''' The system shall be able to define the collection details for registered samples or specimens, including container size and type, number of containers, collection date and time, temperature, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
| | **Food and beverage ingredients |
| |-
| | **Elemental material |
| | style="padding:5px; width:350px;" |
| | **Pharmaceutical ingredients |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-9]<br />
| | **Etc. |
| [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 G1.4]<br />
| | * Reference materials |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<br />
| | **Cannabinoids |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.1]<br />
| | **Coals and cokes |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.5]
| | **Elemental gasses |
| | style="background-color:white;" |'''1.10''' The system should allow for the addition of observations and descriptions to registered samples in the form of free text.
| | **Isotope reference material |
| |-
| | **Organic analytical reference material |
| | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-10]
| | **Pesticides |
| | style="background-color:white;" |'''1.11''' The system should support the creation of user-definable default sample registration preferences and/or input screens.
| | **Etc. |
| |-
| | *Rubbers |
| | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-11]<br />
| | **Bump stops |
| [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 />
| | **Gloves |
| [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 5.8.7)]<br />
| | **Neoprene |
| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2]
| | **Silicone |
| | style="background-color:white;" |'''1.12''' The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.
| | **Tires |
| |-
| | **Etc. |
| | style="padding:5px; width:350px;" |
| | *Electronics and energy devices |
| [https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (c)]<br />
| | **Batteries |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| | **Semiconductors |
| [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />
| | **Solar panels |
| [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br />
| | **Transformers |
| [https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
| | **Etc. |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.2]<br />
| | *Textiles |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual D-3]<br />
| | **Carpet |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-12]<br />
| | **Drapery |
| [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
| | **Non-woven fabrics |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.2]<br />
| | **Upholstery |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.11]<br />
| | **Etc. |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.10]<br />
| | *Wood |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
| | **Dowel |
| [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 15]<br />
| | **Flooring |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]<br />
| | **Lumber |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.2]<br />
| | **Medium-density fibreboard (MDF) |
| [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 />
| | **Etc. |
| [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 5.8.5)]<br />
| | |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1.11]<br />
| | Test method developers: |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.2.5]<br />
| | * Aerospace Industries Association (AIA/NAS/NASM) |
| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2]</ref>
| | * American Architectural Manufacturers Association (AAMA) |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.11]
| | * American Association of State Highway and Transportation Officials (AASHTO) |
| | style="background-color:white;" |'''1.13''' The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
| | * American Association of Textile Chemists and Colorists (AATCC) |
| |-
| | * American Institute of Timber Construction (AITC) |
| | style="padding:5px; width:350px;" |
| | * American National Standards Institute (ANSI) |
| [https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
| | * American Petroleum Institute (API) |
| [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
| | * American Society of Mechanical Engineers (ASME) |
| [https://www.law.cornell.edu/cfr/text/21/58.107 21 CFR Part 58.107 (d)]<br />
| | * American Welding Society (AWS) |
| [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
| | * American Wood Protection Association (AWPA) |
| [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
| | * AOAC International (Association of Official Agricultural Chemists; AOAC) |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-13]<br />
| | * ASTM International (ASTM) |
| [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
| | * Automakers (Ford, GM, Honda, PACCAR, Peugeot, Subaru, Tesla, Toyota, Volvo, etc.) |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<br />
| | * Canadian Standards Association (CSA) |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.7]<br />
| | * Chemical Fabrics & Film Association (CFFA) |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<br />
| | * Consumer Product Safety Commission (CPSC) |
| [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 6.1]<br />
| | * Deutsches Institut für Normung (DIN) |
| [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 5.8.3)]
| | * Electronic Components Industry Association (ECIA/EIA) |
| | style="background-color:white;" |'''1.14''' The system shall provide a user-friendly means for tracking and acknowledging the physical reception of submitted sample or specimen material in the laboratory, including date and time of reception.
| | * European Telecommunications Standards Institute (ETSI) |
| |-
| | * Federal Motor Vehicle Safety Standard (FMVSS) |
| | style="padding:5px; width:350px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-14]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.6]
| | * FM Approvals (FM) |
| | style="background-color:white;" |'''1.15''' The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.
| | * GE Aerospace (GE) |
| |-
| | * Government and military (MIL, [https://fedspecs.gsa.gov/s/federal-standards Fed], Consumer Product Safety Commission, CSFA, EPA, FDA, MMM, NAVSEA, United Nations Economic Commission for Europe, etc.) |
| | style="padding:5px; width:350px;" |
| | * Industrial Fasteners Institute (IFI) |
| [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 C3.3]<br />
| | * Institute of Electrical and Electronics Engineers (IEEE) |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.8.3]<br />
| | * International Atomic Energy Agency (IAEA) ([https://www.iaea.org/topics/material-analysis 1], [https://www.iaea.org/topics/other-non-destructive-testing 2], [https://www.iaea.org/topics/materials 3]) |
| [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.1.5]<br />
| | * International Code Council (ICC-ES) |
| [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.1.6]<br />
| | * International Electrotechnical Commission (IEC) |
| [https://www.astm.org/e1492-11r17.html ASTM E1492-11 4.3.3.2]<br />
| | * International Maritime Organization (IMO) |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-15]<br />
| | * International Organization for Standardization (ISO) |
| [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br />
| | * International Safe Transit Association (ISTA) |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.1.3]<br />
| | * IPC International (Institute for Interconnecting and Packaging Electronic Circuits; IPC) |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.13]<br />
| | * Japanese Standards Association (JAS/JIS) |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.8]<br />
| | * NACE International (National Association of Corrosion Engineers; NACE) |
| [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
| | * National Fire Protection Association (NFPA) |
| [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.dot.ny.gov/divisions/engineering/structures/manuals/scm/repository/SCM_4th_Edition_1-2018.pdf New York State Steel Construction Manual (NNSSCM/SCM)] |
| [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 5.8.7.2)]<br />
| | * NSF International (National Sanitation Foundation; NSF) |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.1.3–7]<br />
| | * Pressure Sensitive Tape Council (PSTC) |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.4.1.1.9]<br />
| | * Radio Technical Commission for Aeronautics (RTCA) |
| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.2 and 5.3.3.1]
| | * Suppliers of Advanced Composite Materials Association (SACMA) |
| | style="background-color:white;" |'''1.16''' The system should provide a means to document any undesirable or unexpected characteristics of a submitted sample.
| | * SAE International (SAE/AMS/AS) |
| |-
| | * TAPPI (Technical Association of the Pulp and Paper Industry; TAPPI) |
| | style="padding:5px; width:350px;" |[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 5.7]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-16]<br />[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.2 and 2.2.3]
| | * Truss Plate Institute (TPI) |
| | style="background-color:white;" |'''1.17''' The system should provide a means to document sample preparation activities for a given sample.
| | * UL Standards and Engagement (UL) |
| |-
| | * United States Pharmacopeia Convention (USP) |
| | style="padding:5px; width:350px;" |
| |
| [https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.11]<br />
| |
| [https://www.law.cornell.edu/cfr/text/7/331.11 7 CFR Part 331.17]<br />
| |
| [https://www.law.cornell.edu/cfr/text/9/121.11 9 CFR Part 121.11]<br />
| |
| [https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/73.11 42 CFR Part 73.11]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1274 42 CFR Part 493.1274]<br />
| |
| [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 4.13]<br />
| |
| [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.8]<br />
| |
| [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. D-9–10]<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 5.8.1.1]<br />
| |
| [https://www.astm.org/e1492-11r17.html ASTM E1492-11 (throughout)]<br />
| |
| [https://www.astm.org/e1578-18.html ASTM E1578-18 C-1-17]<br />
| |
| [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.3.5]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 12]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Appendix A]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.3–5]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.13]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.4.8–9]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.3]<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://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 5.8.7.5 and 5.8.8)]<br />
| |
| [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) (throughout)]
| |
| | style="background-color:white;" |'''1.18''' The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.
| |
| |-
| |
| | style="padding:5px; width:350px;" |[https://www.law.cornell.edu/cfr/text/7/331.16 7 CFR Part 331.16]<br />[https://www.law.cornell.edu/cfr/text/9/121.16 9 CFR Part 121.16]<br />[https://www.law.cornell.edu/cfr/text/42/73.16 42 CFR Part 73.16]
| |
| | style="background-color:white;" |'''1.19''' In the case of regulated samples (e.g., select agent or toxin, cannabis, etc.), the system shall also allow for the recording of transfers to other entities outside the laboratory, including details such as personnel involved, their certification numbers (if applicable), dates, times, and any other required information.
| |
| |-
| |
| | style="padding:5px; width:350px;" |[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 G1.1]<br />[https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]
| |
| | style="background-color:white;" |'''1.20''' The system shall be able to link various records together based on a record's metadata, including sample or specimen identifier, patient number, or family identifier.
| |
| |-
| |
| |}
| |
| |}
| |