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13485 Mapping

The document provides a comprehensive mapping of the ISO 13485:2016 requirements to specific documents, utilizing OpenRegulatory templates. Each section of the standard is aligned with corresponding Standard Operating Procedures (SOPs) and manuals relevant to quality management and medical device processes. Users are encouraged to adapt the document names to fit their own systems as needed.

Uploaded by

Nosiba Yousif
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© © All Rights Reserved
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Download as DOCX, PDF, TXT or read online on Scribd
19 views3 pages

13485 Mapping

The document provides a comprehensive mapping of the ISO 13485:2016 requirements to specific documents, utilizing OpenRegulatory templates. Each section of the standard is aligned with corresponding Standard Operating Procedures (SOPs) and manuals relevant to quality management and medical device processes. Users are encouraged to adapt the document names to fit their own systems as needed.

Uploaded by

Nosiba Yousif
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
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 Computerized Software
6 and Measurement Validation
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

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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