| | Title | Key Documentation Required | Common Templates | |---|---|---|---| | 4.2.2 | Quality Manual | Quality Manual outlining QMS scope, exclusions, process interaction, and documentation structure | Quality Manual Template | | 4.2.3 | Document Control | Documented procedure for document approval, review, update, and version control | SOP Document Control, Document Change Request Form | | 4.2.4 | Control of Records | Documented procedure for record identification, storage, retention, and disposal | Record Retention Schedule, Master Record List | | 5.6 | Management Review | Management review meeting inputs, agenda, minutes, and action items | Management Review Presentation, Minutes Template | | 6.2 | Human Resources | Competency matrix, job descriptions, training records, effectiveness evaluation | Training Log, Competency Assessment Form | | 6.3 | Infrastructure | Maintenance plans, validation protocols, equipment logs | Maintenance Plan, Calibration Checklist | | 7.1 | Planning of Product Realization | Risk management file, product realization plan | Risk Management Plan, Product Realization Plan | | 7.3 | Design & Development | Design plan, inputs/outputs, verification & validation plans, DHF | Design Input/Output Traceability Matrix, V&V Protocol | | 7.4 | Purchasing | Supplier evaluation records, quality agreements, approved supplier list | Supplier Evaluation Form, Quality Assurance Agreement | | 7.5.1 | Production & Service Provision | Work instructions, process validation, equipment logs | Work Instruction, Process Validation Report | | 8.2 | Monitoring & Measurement | Customer feedback records, internal audit reports | Internal Audit Checklist, Customer Satisfaction Survey | | 8.3 | Control of Nonconforming Product | Nonconformance report, disposition records, rework instructions | NCR Form, Material Review Board (MRB) Minutes | | 8.5.2 | Corrective Action (CAPA) | CAPA procedure, root cause analysis, action plan, effectiveness verification | CAPA Request Form, Root Cause Analysis (5 Whys/Fishbone) |
: Compare your current processes against ISO 13485:2016 requirements.
ISO 13485:2016 is the globally recognized Quality Management Systems (QMS) standard for organizations involved in the design, production, installation, and servicing of medical devices. iso 13485 2016 a practical guide pdf full
By understanding the requirements of ISO 13485:2016 and implementing a practical guide, organizations can achieve regulatory compliance, improve patient safety, and enhance their reputation in the medical device industry.
If you need the actual text for legal or certification purposes: | | Title | Key Documentation Required |
🚀 Your QMS must therefore be adaptable enough to handle these MDR-specific requirements while remaining fully compliant with ISO 13485. For many manufacturers, this means integrating clinical, risk, and post-market data into a single, traceable ecosystem.
Documentation is the backbone of your QMS. Establish a lean, four-tier document hierarchy: If you need the actual text for legal
: Covers everything from design control to delivery.
Establish robust processes for gathering post-market feedback and processing customer complaints.
Keep your procedures simple and practical. Writing overly complex SOPs makes them difficult to follow and increases the likelihood of compliance deviations during audits.