13485 Base Templates - #78

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13485_checklist

Commits on Dec 31, 2020

Begin adding 13485 checklist.
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15736d7
Add remaining 13485 checklist items.
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098d391
Add 13485 prefix.
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8e1c545

Commits on Jan 13, 2021

Add initial quality manual compliant to IMDRF /SaMD WG/N23 recommendations.
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54d2cb9
Add SOP creation SOP.
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e41c87a
Add SOP change SOP.
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f6d85e4
Add SOP removal SOP.
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66e7786
Add new record template template.
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690a951
Add SOP review SOP.
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562fe09

Commits on Jan 15, 2021

Commits on Jan 20, 2021

Add tools validation process
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8e2c0c8

Commits on Jan 28, 2021

Restructure init templates.
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16dd24f
Add 21.CFR.820 references.
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71d1c04
Add 21.CFR.820 references and training record.
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dae161f
Add sections to quality manual per 21.CFR.820.
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936660f
Add 21.CFR.820 checklist.
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920acd9
Add risk management process.
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578da06
Change wording of problem report qualification.
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dbee8cf
Reformat whitespace.
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f2d1797
Remove IMDRF version of quality manual.
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ab5a5be
Add Audit SOPs and Record templates
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9c8356e

Commits on Feb 2, 2021

Add training SOP.
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cddcbab

Commits on Mar 9, 2021

Add templates.
yujanshrestha
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b0f1cee
Add verification and validation plan.
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ff1325b
Add risk management process assets.
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0c957f6