memo_artifacts_standards_iso_13485

SysML API

Public namespace	memo::artifacts::standards
Declared package	memo_artifacts_standards_iso_13485
Source	src/artifacts/standards/iso_13485.sysml

Namespace hierarchy

memo → memo::artifacts → memo::artifacts::standards

Packages

Package
memo_artifacts_standards_iso_13485

Imports

Visibility	Target
private	ScalarValues::*
private	memo_core_enumerations::*
private	memo_core_relationships::*
private	memo_artifacts_standards_traceability::*

Declarations

Name	SysML kind	Description	Specializes
—	—	—	—

Source

artifacts/standards/iso_13485.sysml

// ISO 13485:2016 — quality management systems for medical devices.
//
// Only the design-and-development and document-control clauses MEMO documents
// actually claim are represented. The rest of the QMS is a management-system
// concern that no model element traces to, and an unclaimed clause costs
// nothing to add later.
package memo_artifacts_standards_iso_13485 {
    private import ScalarValues::*;
    private import memo_core_enumerations::*;
    private import memo_core_relationships::*;
    private import memo_artifacts_standards_traceability::*;

    item iso13485 : RegulatoryStandard {
        attribute :>> id = "STD-ISO-13485";
        attribute :>> name = "ISO13485";
        attribute :>> designation = "ISO 13485:2016";
        attribute :>> edition = "2016";
        attribute :>> issuer = "ISO";
        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA);
    }

    item iso13485Clause4 : StandardClause {
        attribute :>> id = "STD-ISO-13485-4";
        attribute :>> name = "ISO13485Clause4";
        attribute :>> clauseNumber = "4";
        attribute :>> title = "quality management system";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause4_2 : StandardClause {
        attribute :>> id = "STD-ISO-13485-4-2";
        attribute :>> name = "ISO13485Clause4_2";
        attribute :>> clauseNumber = "4.2";
        attribute :>> title = "quality management system documentation";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause4_2_4 : StandardClause {
        attribute :>> id = "STD-ISO-13485-4-2-4";
        attribute :>> name = "ISO13485Clause4_2_4";
        attribute :>> clauseNumber = "4.2.4";
        attribute :>> title = "control of documents";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause7 : StandardClause {
        attribute :>> id = "STD-ISO-13485-7";
        attribute :>> name = "ISO13485Clause7";
        attribute :>> clauseNumber = "7";
        attribute :>> title = "product realization";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause7_3 : StandardClause {
        attribute :>> id = "STD-ISO-13485-7-3";
        attribute :>> name = "ISO13485Clause7_3";
        attribute :>> clauseNumber = "7.3";
        attribute :>> title = "design and development";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause7_3_3 : StandardClause {
        attribute :>> id = "STD-ISO-13485-7-3-3";
        attribute :>> name = "ISO13485Clause7_3_3";
        attribute :>> clauseNumber = "7.3.3";
        attribute :>> title = "design and development inputs";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause7_3_4 : StandardClause {
        attribute :>> id = "STD-ISO-13485-7-3-4";
        attribute :>> name = "ISO13485Clause7_3_4";
        attribute :>> clauseNumber = "7.3.4";
        attribute :>> title = "design and development outputs";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause7_3_6 : StandardClause {
        attribute :>> id = "STD-ISO-13485-7-3-6";
        attribute :>> name = "ISO13485Clause7_3_6";
        attribute :>> clauseNumber = "7.3.6";
        attribute :>> title = "design and development verification";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause7_3_7 : StandardClause {
        attribute :>> id = "STD-ISO-13485-7-3-7";
        attribute :>> name = "ISO13485Clause7_3_7";
        attribute :>> clauseNumber = "7.3.7";
        attribute :>> title = "design and development validation";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause7_3_9 : StandardClause {
        attribute :>> id = "STD-ISO-13485-7-3-9";
        attribute :>> name = "ISO13485Clause7_3_9";
        attribute :>> clauseNumber = "7.3.9";
        attribute :>> title = "control of design and development changes";
        attribute :>> normativeStrength = "shall";
    }
    item iso13485Clause7_3_10 : StandardClause {
        attribute :>> id = "STD-ISO-13485-7-3-10";
        attribute :>> name = "ISO13485Clause7_3_10";
        attribute :>> clauseNumber = "7.3.10";
        attribute :>> title = "design and development files";
        attribute :>> normativeStrength = "shall";
    }

    connection iso13485Has4 : Composes connect parent ::> iso13485 to child ::> iso13485Clause4;
    connection iso13485Has7 : Composes connect parent ::> iso13485 to child ::> iso13485Clause7;

    connection iso13485Has4_2 : Composes connect parent ::> iso13485Clause4 to child ::> iso13485Clause4_2;
    connection iso13485Has4_2_4 : Composes connect parent ::> iso13485Clause4_2 to child ::> iso13485Clause4_2_4;

    connection iso13485Has7_3 : Composes connect parent ::> iso13485Clause7 to child ::> iso13485Clause7_3;
    connection iso13485Has7_3_3 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_3;
    connection iso13485Has7_3_4 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_4;
    connection iso13485Has7_3_6 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_6;
    connection iso13485Has7_3_7 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_7;
    connection iso13485Has7_3_9 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_9;
    connection iso13485Has7_3_10 : Composes connect parent ::> iso13485Clause7_3 to child ::> iso13485Clause7_3_10;
}