ISO 13485 Certification Kit

Description

Achieving ISO 13485 certification is a critical milestone for any medical device manufacturer, showcasing your commitment to quality, compliance, and patient safety. Our ISO 13485 Certification Kit is a comprehensive package designed to simplify the implementation of an ISO 13485-compliant Quality Management System (QMS). Packed with meticulously crafted Standard Operating Procedures (SOPs), templates, and supporting documentation, this kit provides everything you need to streamline your certification journey.  

What’s Included in the ISO 13485 Certification Kit?

1. Comprehensive SOP Library Gain access to a full collection of SOPs tailored to meet ISO 13485 requirements. These documents cover all key areas of QMS implementation, including:
   • Document and Record Control
   • Risk Management Processes (aligned with ISO 14971)
   • Supplier Management
   • Design and Development Controls
   • Internal Audits and Management Reviews
   • Nonconformance and Corrective Actions
   • Complaint Handling and Post-Market Surveillance
2. Ready-to-Use Templates Save time and resources with prebuilt templates designed to simplify your QMS implementation. Templates include:
   • Quality Manual
   • Risk Management Plan
   • CAPA Reports
   • Supplier Evaluation Forms
   • Audit Checklists
   • Training Records
   • Change Control Logs
3. Full Support Full support is provided in case anything is needed in relation to the documentation kit.

Why Choose Our ISO 13485 Certification Kit?

1. Regulatory Compliance Made Easy Designed to meet the requirements of ISO 13485, this kit ensures your QMS aligns with international standards. Whether preparing for certification or maintaining compliance, this package equips you with the tools to meet regulatory expectations confidently.
2. Comprehensive and User-Friendly The kit is designed for ease of use, with clear instructions and editable formats. You can quickly tailor each document to match your organization’s processes, saving valuable time and reducing the complexity of QMS implementation.
3. Cost-Effective Solution Hiring consultants or creating documentation from scratch can be expensive and time-consuming. This kit offers a budget-friendly alternative, delivering high-quality, professional-grade materials at a fraction of the cost.
4. Audit-Ready Documentation All documents are structured to ensure seamless audits by certification bodies. Demonstrate your organization’s commitment to quality with a complete and professional QMS documentation set.
5. Scalable for Organizations of Any Size Whether you’re a startup or an established medical device manufacturer, this kit is flexible enough to meet your specific needs and grow with your organization.

Topic	Procedure Title
Management Review Process	Management Review Procedure
	Management Review Template
Risk Management Process	Risk Management Procedure
	Risk Management Plan Template Risk Management Report Template Risk Analysis Template Hazard Analysis Template Traceability Matrix Template
Internal Audit Process	Audit Management Procedure
	Annual Audit Planning Template Audit Plan Template  Audit Report Template
Human Resources / Training Process	Human Resources and Training Management Procedure
Software Validation Procedure	Computer System Validation Procedure
CAPA Process	Corrective and Preventive Actions Procedure
	CAPA Template Capa Database Template
Non-Conformity Process	Non-Conformity Management Procedure
Change Management Process	Change Control Procedure  Notified Body Change Notification Procedure
	Change Control Template Change Control Database Template
	Document Control Procedure
Complaint Management Process	Complaint Management Procedure
	Complaint Handling Template Database Customer Complaints  Database Customer Feedback
Vigilance Reporting Process	EU Vigilance Reporting Procedure Procedure for Management of Field Actions/Advisory Notices
	Data Sanitization and Disposal
Design Control Process	Design Control Procedure
	Design and Development Plan Template Design Inputs Template Design Verification Plan Template Design Transfer Checklist Design Review Template Biological Risk Assessment Template Design History File Index Template Device Master Record Index Template
Supplier Management Process	Supplier Management Procedure
	Initial Supplier Evaluation Template  Supplier Monitoring Template  Supplier List Template
Data Analysis Process	KPI & Data Analysis Procedure
	KPI List & Data Analysis Template Risk Analysis QMS Processes Template
Process Validation	Process Validation Procedure
Clinical Evaluation & Investigation Process	Clinical Evaluation Procedure
	Investigator Brochure Template
UDI Management Process	UDI Management Procedure
Post-Market Surveillance Process	Post-Market Surveillance Procedure
	Post-market Surveillance Plan Template Post-Market Surveillance Report Template Periodic Safety Update Report (PSUR) Template
Management of Technical Dossier	Medical Device File Procedure
Customer-Related Process	Customer Related Process Procedure
	Labelling and Management of Translations Procedure E-Labelling Management Procedure
Sterilization Process	Validation of Ionizing Sterilization Procedure
Infrastructure, Work Environment and Equipment Management	Infrastructure and Work Environment Procedure Control of Equipment Procedure
Manufacturing Operations	Production and Service Provision Procedure Incoming Control Procedure
Usability Management	Usability Procedure  Usability File Template
Purchase Management	Purchase Management Procedure Purchase Order Template
Strategy for Regulatory Compliance	Strategy for Regulatory Compliance Procedure (Template)