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