ISO 13485: Documentation Requirements
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The new ISO 13485 is based on ISO 9001:2008, meaning its documentation requirements build on the previous version of ISO 9001, with additions specific to the medical device industry. Below is a list of mandatory ISO 13485 documents. Keep in mind that a Quality Management System (QMS) consists not only of these mandatory documents but also of other documents specified by applicable regulatory requirements.
Key ISO 13485 Documentation Requirements
Quality Manual
Responsibilities and Authorities
Medical Device File
Procedure for Document Control
Procedure for Design and Development
Procedure for Validation
Standard Clause 4: Quality Management System
Roles under Regulatory Requirements (clause 4.1.1)
Validation of Computer Software Application (clause 4.1.6)
Quality Manual (clause 4.2.2)
Medical Device File (clause 4.2.3)
Procedure for Document Control (clause 4.2.4)
Procedure for Record Control (clause 4.2.5)
Standard Clause 5: Management Responsibilities
Quality Policy (clause 5.3)
Quality Objectives (clause 5.4.1)
Responsibilities and Authorities (clause 5.5.1)
Procedure for Management Review (clause 5.6.1)
Standard Clause 6: Resource Management
Procedure for Training (clause 6.2)
Infrastructure and Maintenance Activities (clause 6.3)
Work Environment Requirements (clause 6.4.1)
Control of Contaminated Products (clause 6.4.2)
Standard Clause 7: Product Realization
Risk Management Process (clause 7.1)
Product Realization Planning Outputs (clause 7.1)
Customer Requirements Review Records (clause 7.2.2)
Customer Communication Arrangements (clause 7.2.3)
Procedure for Design and Development (clause 7.3.1)
Design and Development Planning (clause 7.3.2)
Design and Development Outputs (clause 7.3.4)
Design and Development Review Records (clause 7.3.5)
Design Verification Plans and Results (clause 7.3.6)
Design Validation Plans and Results (clause 7.3.6)
Procedure for Transfer of Design Outputs to Manufacturing (clause 7.3.8)
Control of Design and Development Changes (clause 7.3.9)
Design and Development File (clause 7.3.10)
Procedure for Purchasing (clause 7.4.1)
Supplier Evaluation and Selection Records (clause 7.4.1)
Verification of Purchased Product (clause 7.4.3)
Traceability Records (clause 7.5.1)
Product Cleanliness Requirements (clause 7.5.2)
Medical Device Installation Requirements (clause 7.5.3)
Servicing of Medical Devices (clause 7.5.4)
Sterilization Process Records (clause 7.5.5)
Process Validation Records (clause 7.5.6)
Validation of Sterilization Processes (clause 7.5.7)
Procedure for Product Identification (clause 7.5.8)
Procedure for Traceability (clause 7.5.9.1)
Shipping Package Consignee Records (clause 7.5.9.2)
Customer Property Changes Report (clause 7.5.10)
Procedure for Preserving Product Conformity (clause 7.5.11)
Monitoring and Measuring Procedure (clause 7.6)
Calibration Records (clause 7.6)
Validation of Software for Monitoring and Measuring (clause 7.6)
Standard Clause 8: Measurement, Analysis, and Improvement
Customer Feedback Procedure (clause 8.2.1)
Complaint Handling Procedure (clause 8.2.2)
Reporting to Regulatory Authorities (clause 8.2.3)
Internal Audit Procedure (clause 8.2.4)
Audit Records (clause 8.2.4)
Product Release Authorization Identity (clause 8.2.6)
Control of Nonconforming Product Procedure (clause 8.3.1)
Rework Records (clause 8.3.4)
Data Analysis Procedure (clause 8.4)
Corrective Action Procedure (clause 8.5.2)
Preventive Action Procedure (clause 8.5.3)
The Importance of Documentation
Documentation ensures that critical processes are understood and repeatable. To achieve this, processes should be as simple as possible and presented clearly. Graphical flow charts can effectively relay all relevant information quickly and easily. Simplifying process documentation ensures that all employees can consistently deliver quality outcomes.
In the long run, the simpler, the better. This encapsulates the essence of ISO 13485 good documentation practices.
