Template: ISO 13485: Mapping of Requirements to Documents

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This table maps all requirements of the ISO 13485:2016 (by section) to the relevant documents.

Note that the document names in the “Fulfilled in Document” column are based on the OpenRegulatory templates. You’ll probably have a different system for assigning document names, so feel free to rename them.

ISO 13485:2016

SectionTitleDocument
4.1General QMS RequirementsQuality Management Manual
SOP Management Review
SOP Purchasing
SOP Software Validation
4.2.1General Documentation RequirementsQuality Management Manual
4.2.2Quality Management ManualQuality Management Manual
4.2.3Medical Device FileSOP Product Certification and Registration
SOP Integrated Software Development
4.2.4Control of DocumentsSOP Document and Record Control
4.2.5Control of RecordsSOP Document and Record Control
5.1Management ObligationsQuality Management Manual
Template Annual Strategic Goals
SOP Management Review
5.2Client OrientationSOP Update of Regulations
Template Annual Strategic Goals
5.3Quality PoliciesQuality Management Manual
Template Annual Strategic Goals
SOP Management Review
5.4QMS Planning and Quality GoalsQuality Management Manual
Template Annual Strategic Goals
SOP Management Review
5.5Responsibilities, Competencies and CommunicationQuality Management Manual
5.6Management ReviewSOP Management Review
6.1Allocation of ResourcesTemplate Annual Strategic Goals
SOP Management Review
6.2Staff ResourcesSOP Human Resources Administration
6.3InfrastructureSOP Software Validation
6.4Work Environment– not applicable –
6.4.2Control of Contamination– not applicable –
7.1Planning of Product DevelopmentSOP Integrated Software Development
7.2Customer-Oriented ProcessesSOP Integrated Software Development
SOP Feedback Management
7.3DevelopmentSOP Integrated Software Development
SOP Product Certification and Registration
SOP Change Management
7.4PurchasingSOP Purchasing
7.5Production and Service ProvisionSOP Integrated Software Development
7.5.5Special Requirements for Sterile Medical Devices– not applicable –
7.5.9TraceabilitySOP Product Certification and Registration
7.6Control of Surveillance and MeasurementSOP Post-Market Surveillance
SOP Software Validation
8.1General Measurement, Analysis and ImprovementSOP Integrated Software Development
SOP Internal Auditing
SOP Management Review
8.2.1FeedbackSOP Feedback Management
8.2.2Complaint ProcessingSOP Feedback Management
SOP Corrective and Preventive Actions
8.2.3Reporting to AuthoritiesSOP Incident Reporting
8.2.4Internal AuditSOP Internal Auditing
8.2.5Surveillance and Measurement of ProcessesSOP Management Review
8.2.6Surveillance and Measurement of ProductsSOP Post-Market Surveillance
8.3Control of Nonconforming ProductsSOP Corrective and Preventive Actions
SOP Incident Reporting
8.48.4 Data AnalysisSOP Management Review
8.58.5 Improvement: Corrective and Preventive ActionSOP Corrective and Preventive Actions

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