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
Se
cti
on Title Document
4. General QMS Quality Management ManualSOP Management ReviewSOP
1 Requirements PurchasingSOP Software Validation
4. General Documentation Quality Management Manual
2. Requirements
1
4. Quality Management Quality Management Manual
2. Manual
2
4. Medical Device File SOP Product Certification and RegistrationSOP Integrated
2. Software Development
3
4. Control of Documents SOP Document and Record Control
2.
4
4. Control of Records SOP Document and Record Control
2.
5
5. Management Quality Management ManualTemplate Annual Strategic
1 Obligations GoalsSOP Management Review
5. Client Orientation SOP Update of RegulationsTemplate Annual Strategic
2 Goals
5. Quality Policies Quality Management ManualTemplate Annual Strategic
3 GoalsSOP Management Review
5. QMS Planning and Quality Management ManualTemplate Annual Strategic
4 Quality Goals GoalsSOP Management Review
5. Responsibilities, Quality Management Manual
5 Competencies and
Communication
Se
cti
on Title Document
5. Management Review SOP Management Review
6
6. Allocation of Resources Template Annual Strategic GoalsSOP Management Review
1
6. Staff Resources SOP Human Resources Administration
2
6. Infrastructure SOP Software Validation
3
6. Work Environment - not applicable -
4
6. Control of - not applicable -
4. Contamination
2
7. Planning of Product SOP Integrated Software Development
1 Development
7. Customer-Oriented SOP Integrated Software DevelopmentSOP Feedback
2 Processes Management
7. Development SOP Integrated Software DevelopmentSOP Product
3 Certification and RegistrationSOP Change Management
7. Purchasing SOP Purchasing
4
7. Production and Service SOP Integrated Software Development
5 Provision
7. Special Requirements - not applicable -
5. for Sterile Medical
5 Devices
7. Traceability SOP Product Certification and Registration
5.
9
7. Control of Surveillance SOP Post-Market SurveillanceSOP Software Validation
6 and Measurement
8. General Measurement, SOP Integrated Software DevelopmentSOP Internal
1 Analysis and AuditingSOP Management Review
Improvement
8. Feedback SOP Feedback Management
2.
1
8. Complaint Processing SOP Feedback ManagementSOP Corrective and Preventive
 Se
cti
on Title Document
2. Actions
2
8. Reporting to Authorities SOP Incident Reporting
2.
3
8. Internal Audit SOP Internal Auditing
2.
4
8. Surveillance and SOP Management Review
2. Measurement of
5 Processes
8. Surveillance and SOP Post-Market Surveillance
2. Measurement of
6 Products
8. Control of SOP Corrective and Preventive ActionsSOP Incident
3 Nonconforming Reporting
Products
8. 8.4 Data Analysis SOP Management Review
4
8. 8.5 Improvement: SOP Corrective and Preventive Actions
5 Corrective and
Preventive Action

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