13485-mapping

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ISO 13485:2016 Mapping of Requirements to Documents

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

Section Title Document
4.1 General QMS Requirements Quality Management Manual
SOP Management Review
SOP Purchasing
SOP Software Validation
4.2.1 General Documentation Requirements Quality Management Manual
4.2.2 Quality Management Manual Quality Management Manual
4.2.3 Medical Device File SOP Product Certification and Registration
SOP Integrated Software Development
4.2.4 Control of Documents SOP Document and Record Control
4.2.5 Control of Records SOP Document and Record Control
5.1 Management Obligations Quality Management Manual
Template Annual Strategic Goals
SOP Management Review
5.2 Client Orientation SOP Update of Regulations
Template Annual Strategic Goals
5.3 Quality Policies Quality Management Manual
Template Annual Strategic Goals
SOP Management Review
5.4 QMS Planning and Quality Goals Quality Management Manual
Template Annual Strategic Goals
SOP Management Review
5.5 Responsibilities, Competencies and Communication Quality Management Manual
5.6 Management Review SOP Management Review
6.1 Allocation of Resources Template Annual Strategic Goals
SOP Management Review
6.2 Staff Resources SOP Human Resources Administration
6.3 Infrastructure SOP Software Validation
6.4 Work Environment - not applicable -
6.4.2 Control of Contamination - not applicable -
7.1 Planning of Product Development SOP Integrated Software Development
7.2 Customer-Oriented Processes SOP Integrated Software Development
SOP Feedback Management
7.3 Development SOP Integrated Software Development
SOP Product Certification and Registration
SOP Change Management
7.4 Purchasing SOP Purchasing
7.5 Production and Service Provision SOP Integrated Software Development
7.5.5 Special Requirements for Sterile Medical Devices - not applicable -
7.5.9 Traceability SOP Product Certification and Registration
7.6 Control of Surveillance and Measurement SOP Post-Market Surveillance
SOP Computerized Software Validation
8.1 General Measurement, Analysis and Improvement SOP Integrated Software Development
SOP Internal Auditing
SOP Management Review
8.2.1 Feedback SOP Feedback Management
8.2.2 Complaint Processing SOP Feedback Management
SOP Corrective and Preventive Actions
8.2.3 Reporting to Authorities SOP Incident Reporting
8.2.4 Internal Audit SOP Internal Auditing
8.2.5 Surveillance and Measurement of Processes SOP Management Review
8.2.6 Surveillance and Measurement of Products SOP Post-Market Surveillance
8.3 Control of Nonconforming Products SOP Corrective and Preventive Actions
SOP Incident Reporting
8.4 8.4 Data Analysis SOP Management Review
8.5 8.5 Improvement: Corrective and Preventive Action SOP Corrective and Preventive Actions

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