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::*
private	memo_core_common::*
private	memo_core_common::MemoIdentity

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::*;

    private import memo_core_common::*;
    private import memo_core_common::MemoIdentity;
    part iso13485 : RegulatoryStandard {
        @MemoIdentity { :>> providedId = "STD-ISO-13485"; }
        attribute :>> designation = "ISO 13485:2016";
        attribute :>> edition = "2016";
        attribute :>> issuer = "ISO";
        attribute :>> appliesToRegime = (RegulatoryRegimeKind::CE, RegulatoryRegimeKind::MDR, RegulatoryRegimeKind::UKCA);
        part iso13485Clause4 : StandardClause {
            @MemoIdentity { :>> providedId = "STD-ISO-13485-4"; }
            attribute :>> clauseNumber = "4";
            attribute :>> title = "quality management system";
            attribute :>> normativeStrength = "shall";
            part iso13485Clause4_2 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-ISO-13485-4-2"; }
                attribute :>> clauseNumber = "4.2";
                attribute :>> title = "quality management system documentation";
                attribute :>> normativeStrength = "shall";
                part iso13485Clause4_2_4 : StandardClause {
                    @MemoIdentity { :>> providedId = "STD-ISO-13485-4-2-4"; }
                    attribute :>> clauseNumber = "4.2.4";
                    attribute :>> title = "control of documents";
                    attribute :>> normativeStrength = "shall";
                }
            }
        }
        part iso13485Clause7 : StandardClause {
            @MemoIdentity { :>> providedId = "STD-ISO-13485-7"; }
            attribute :>> clauseNumber = "7";
            attribute :>> title = "product realization";
            attribute :>> normativeStrength = "shall";
            part iso13485Clause7_3 : StandardClause {
                @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3"; }
                attribute :>> clauseNumber = "7.3";
                attribute :>> title = "design and development";
                attribute :>> normativeStrength = "shall";
                part iso13485Clause7_3_3 : StandardClause {
                    @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-3"; }
                    attribute :>> clauseNumber = "7.3.3";
                    attribute :>> title = "design and development inputs";
                    attribute :>> normativeStrength = "shall";
                }
                part iso13485Clause7_3_4 : StandardClause {
                    @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-4"; }
                    attribute :>> clauseNumber = "7.3.4";
                    attribute :>> title = "design and development outputs";
                    attribute :>> normativeStrength = "shall";
                }
                part iso13485Clause7_3_6 : StandardClause {
                    @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-6"; }
                    attribute :>> clauseNumber = "7.3.6";
                    attribute :>> title = "design and development verification";
                    attribute :>> normativeStrength = "shall";
                }
                part iso13485Clause7_3_7 : StandardClause {
                    @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-7"; }
                    attribute :>> clauseNumber = "7.3.7";
                    attribute :>> title = "design and development validation";
                    attribute :>> normativeStrength = "shall";
                }
                part iso13485Clause7_3_9 : StandardClause {
                    @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-9"; }
                    attribute :>> clauseNumber = "7.3.9";
                    attribute :>> title = "control of design and development changes";
                    attribute :>> normativeStrength = "shall";
                }
                part iso13485Clause7_3_10 : StandardClause {
                    @MemoIdentity { :>> providedId = "STD-ISO-13485-7-3-10"; }
                    attribute :>> clauseNumber = "7.3.10";
                    attribute :>> title = "design and development files";
                    attribute :>> normativeStrength = "shall";
                }
            }
        }
    }




}