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Mapping

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17 views3 pages

Mapping

123

Uploaded by

m.monir.sa
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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 Quality Management ManualSOP Management
Requirements ReviewSOP PurchasingSOP Software Validation
4.2.1 General Quality Management Manual
Documentation
Requirements
4.2.2 Quality Management Quality Management Manual
Manual
4.2.3 Medical Device File SOP Product Certification and RegistrationSOP
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 Quality Management ManualTemplate Annual
Obligations Strategic GoalsSOP Management Review
5.2 Client Orientation SOP Update of RegulationsTemplate Annual Strategic
Goals
5.3 Quality Policies Quality Management ManualTemplate Annual
Strategic GoalsSOP Management Review
5.4 QMS Planning and Quality Management ManualTemplate Annual
Quality Goals Strategic GoalsSOP Management Review
5.5 Responsibilities, Quality Management Manual
Competencies and
Communication
5.6 Management Review SOP Management Review
6.1 Allocation of Template Annual Strategic GoalsSOP Management
Resources 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 - not applicable -
Section Title Document
Contamination
7.1 Planning of Product SOP Integrated Software Development
Development
7.2 Customer-Oriented SOP Integrated Software DevelopmentSOP Feedback
Processes Management
7.3 Development SOP Integrated Software DevelopmentSOP Product
Certification and RegistrationSOP Change Management
7.4 Purchasing SOP Purchasing
7.5 Production and SOP Integrated Software Development
Service Provision
7.5.5 Special Requirements - not applicable -
for Sterile Medical
Devices
7.5.9 Traceability SOP Product Certification and Registration
7.6 Control of Surveillance SOP Post-Market SurveillanceSOP Software Validation
and Measurement
8.1 General Measurement, SOP Integrated Software DevelopmentSOP Internal
Analysis and AuditingSOP Management Review
Improvement
8.2.1 Feedback SOP Feedback Management
8.2.2 Complaint Processing SOP Feedback ManagementSOP Corrective and
Preventive Actions
8.2.3 Reporting to SOP Incident Reporting
Authorities
8.2.4 Internal Audit SOP Internal Auditing
8.2.5 Surveillance and SOP Management Review
Measurement of
Processes
8.2.6 Surveillance and SOP Post-Market Surveillance
Measurement of
Products
8.3 Control of SOP Corrective and Preventive ActionsSOP Incident
Nonconforming Reporting
Products
8.4 8.4 Data Analysis SOP Management Review
8.5 8.5 Improvement: SOP Corrective and Preventive Actions
Corrective and
Preventive Action
Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.

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