ISO 13485 2016 Package
2025-06-27 15:21ISO 13485 2016 Package
ISO 13485 Documentation Package
2016 version
Real value: $2000+ in saved hours and consulting fees
Price : 389 $
Certification Made Simple and Accessible for Your Business
If you’re involved in the design, production, or distribution of medical devices, chances are you’re always looking for ways to strengthen quality control and demonstrate compliance with regulatory requirements.
That’s where the ISO 13485:2016 Documentation Package comes in.
This package includes all the essential documents you need to achieve ISO 13485 certification, the international standard that sets requirements for a quality management system (QMS) specific to the medical device industry.
So why wait? Get started today and take the next step toward ISO 13485:2016 certification and global market access!
Why start with a blank page. Start your Project TODAY, and save up to 80% on your time and money.
This package comes with 1 hour Live 1-to-1 Online Session with ISO consultant, document reviews, continual email support for 12 months and regular update service.
Cost-Effective Implementation: Much cheaper than an on-site consultant, and requires much less time than doing it from scratch
ISO 13485 Documentation Package
Added Value: All ISO 13485:2016 requirements have been developed into an efficient quality management framework that adds value to your medical device operations and boosts overall productivity.
Effective: Minimal effort is required to implement and follow the procedures necessary to meet all ISO 13485 compliance requirements.
Simplified: Unnecessary bureaucracy and documentation burden have been eliminated—making your system easy to manage while staying fully compliant with ISO 13485:2016.
Start your Project TODAY, and save up to 80% on your time and money.
👉 What is ISO 13485:2016?
ISO 13485:2016 is an international standard that sets requirements for a quality management system (QMS) specific to the medical device industry. It ensures that organizations involved in the design, production, installation, and servicing of medical devices consistently meet regulatory and customer requirements—building trust in the safety and performance of their products.
Key Objectives of the Standard:
Establish a reliable and structured QMS framework for medical device organizations
Ensure consistency, compliance, and product safety across all stages of the product lifecycle
Strengthen customer and regulatory confidence in medical device quality
Outline requirements for risk management, traceability, validation, and process control
What Does the Standard Cover?
🔹 Quality Management Principles
Defines core requirements for maintaining product quality and meeting regulatory obligations
Promotes risk-based thinking, process consistency, and continuous improvement
🔹 Management System Requirements
Organizations must implement a documented quality management system tailored to the medical device industry
Emphasizes documentation control, internal audits, management reviews, and complaint handling
Addresses regulatory compliance and the importance of data integrity, traceability, and documentation
🔹 Product Realization and Process Control
Outlines steps for design and development, purchasing, production, and servicing
Requires validation of processes and control of nonconforming products
Ensures device safety and performance through verified procedures and skilled personnel
Why is ISO 13485:2016 Important?
✅ Ensures organizations deliver safe, effective, and compliant medical devices
✅ Enhances credibility with regulators, customers, and notified bodies
✅ Supports market access through internationally recognized certification
✅ Improves quality and operational efficiency by enforcing rigorous QMS practices
ISO 13485:2016 is the cornerstone for quality assurance in the medical device industry. Implementing this standard not only ensures regulatory compliance but also helps organizations deliver reliable, high-quality medical products that meet both customer and legal expectations worldwide.
The all-in-one ISO 13485 Documentation Package
Save time, save money and simplify the certification process.
Documents included:
This package provides you with the following features:
- Full lifetime access
- Access on a laptop, desktop, and mobile
Procedures:
- Quality Manual
- Document Control Procedure
- Record Control Procedure
- Management Review Procedure
- Internal Audit Procedure
- Corrective Action Procedure
- Preventive Action Procedure
- Risk Management Procedure
- Design and Development Procedure
- Purchasing Procedure
- Supplier Evaluation Procedure
- Receiving Inspection Procedure
- Production Control Procedure
- Calibration Procedure
- Maintenance Procedure
- Training Procedure
- Nonconforming Product Procedure
- Complaint Handling Procedure
- Advisory Notice Procedure
- Regulatory Reporting Procedure
- CAPA Procedure
Manual and quality policy
- ISO 13485 Quality Manual
Standard Operating Procedures (SOPs)
- SOP for Quality System Maintenance
- SOP for Change Management
- SOP for Labeling and Packaging
- SOP for Product Storage and Distribution
- SOP for Traceability
- SOP for Validation and Verification Activities
- SOP for Installation and Servicing
- SOP for Sterilization Process Control (if applicable)
- SOP for Cleanroom Procedures (if applicable)
- SOP for Software Validation (if applicable)
- SOP for Post-Market Surveillance
- SOP for Medical Device Reporting
- SOP for Cybersecurity Management (if applicable)
- SOP for Environmental Monitoring (if applicable)
- SOP for Product Return and Recall
ISO 13485 Documentation Requirements Explained
The ISO 13485:2016 Documentation Package is a must-have for organizations involved in the design, manufacturing, and distribution of medical devices. This package includes all the essential documentation your organization needs to comply with ISO 13485:2016, the international standard that outlines the requirements for a robust quality management system (QMS) in the medical device sector.
Comprehensive and well-structured documentation is essential to ensure a safe, effective, and regulatory-compliant medical device lifecycle. From product realization procedures to risk management and complaint handling, this package enhances your operational efficiency, strengthens quality assurance, and supports successful certification.
Why ISO 13485 Documentation Matters
Proper documentation is the foundation of a reliable and compliant QMS. It provides the structure for consistent product quality, informed decision-making, and evidence of compliance with regulatory and customer requirements worldwide.
This Package Includes:
Key ISO 13485 Documentation Categories
| Document | Purpose in QMS |
|---|---|
| Quality Manual | Outlines the scope and structure of the QMS |
| Document & Record Control Procedures | Ensure accurate control and retention of documentation |
| Risk Management Procedure | Identifies, evaluates, and mitigates product-related risks |
| Design and Development Procedure | Guides product design in compliance with safety standards |
| Supplier Evaluation Procedure | Verifies and monitors supplier capabilities and compliance |
| Purchasing & Receiving Procedures | Control quality of incoming materials and components |
| Production Control Procedure | Standardizes manufacturing and assembly processes |
| Calibration & Maintenance Procedures | Ensure accuracy and reliability of equipment |
| Training Procedure | Maintains staff competency through qualification and records |
| Nonconforming Product Procedure | Identifies and handles defective or out-of-spec products |
| Complaint Handling & CAPA Procedures | Address customer issues and drive continual improvement |
| Advisory Notice & Regulatory Reporting | Manages field safety notices and legal reporting obligations |
Core ISO 13485 Documentation Requirements
Quality Management System Documentation
To comply with ISO 13485:2016, your organization must implement a documented, process-driven QMS. Essential components include:
Quality Manual – Defines quality policy, organizational structure, and process interactions
Standard Operating Procedures (SOPs) – Detail core processes like production, traceability, and corrective actions
Record Control & Change Management – Ensure document integrity and version control
Management Review & Internal Audit Procedures – Evaluate system performance and ensure continual improvement
Operational Process Documentation
This package supports consistent and traceable processes, which are vital for device safety and regulatory approval:
Work Instructions & Inspection Checklists – Provide detailed guidance at each operational step
Process Validation Documents – Ensure repeatability and compliance in critical processes
Device Master Records & Batch Records – Support full traceability of products and components
Regulatory & Post-Market Documentation
Stay compliant with global regulatory bodies through structured post-market procedures:
Complaint and Incident Management – Document product issues, investigations, and field actions
Advisory Notices – Communicate safety-related updates to regulators and customers
Regulatory Reporting Templates – Support reporting to authorities like the FDA or EU competent authorities
Ensure Compliance with ISO 13485:2016 Today!
Achieving ISO 13485:2016 certification is a critical step in accessing global markets and assuring customers of your commitment to quality and safety. With the ISO 13485 Documentation Package, your organization will have everything needed to meet requirements, reduce risks, and operate with confidence.
💡 Get started today and elevate your medical device QMS with a complete, compliant, and efficient documentation toolkit!
30 Days Money Back Guarantee
If for whatever reason during the FIRST 30 days of your purchase, you are not satisfied for any reason, simply contact support@qse-academy.com and our support team will issue you an immediate and full refund.
The package includes all the documents you need to comply with ISO 13485 2016 – these documents are fully acceptable by the certification audit.
All documents are in MS Word or MS Excel, to make them very easy to customize for your business. You can customize them by adding company logos and colors, and edit headers and footers to match your favorite style.
We have already completed about 90% of the information requested on the documents. To complete them you must fill in only the name of the company, the responsible parties, and any other information unique to your company. you will be guided through the process, commenting on the elements that are needed and those that are optional.
All the documents are made so that you can follow the proposed order perfectly, which allows you to make sure that nothing is missing, and that no one gets lost in the process.
The included comments and flowcharts help your staff understand each document and its usefulness, which helps you to make quality management more fluid, and processes easier to follow.
Features of the ISO 13485 Documentation Package
Price: 389 $
– Documentation included: 58 documents for the implementation of ISO 13485
– Language: English
– Documents are fully editable – just enter the information specific to your business.
– Acceptable for the ISO ISO 13485 2016 certification audit? Yes, all the documents required by ISO ISO 13485 2016 are included, as well as the quality policy and the current but optional procedures.
Instant Delivery – The package is downloadable immediately after purchase
Free Consultation – In addition, you can submit two complete documents for review by professionals.
Created for your business – The models are optimized for small and medium businesses.
ISO 13485 Documentation Package
The complete kit to implement ISO 13485
Price : 389 $
What our customers think:
This package made ISO 13485 implementation incredibly smooth. The documents were clear, comprehensive, and saved us weeks of prep time.
Dr. Laura C.
QA/RA Director
A lifesaver for our certification process. We passed our audit with zero major findings, thanks to the ready-to-use templates and well-structured procedures.
Markus I.
Quality Manager
Frequently Asked Questions
How long will it take to receive the complete package of documents after I place my order?
Upon completing your purchase, you will be redirected to the download page immediately. Additionally, a link to access your file will be sent to your email. The files are provided in a .zip format, which you will need to extract. If you encounter any issues with the download, please do not hesitate to contact us at support@qse-academy.com. Our support team is always ready to assist you.
What payment methods can I use?
We offer several payment options for your convenience. You can choose to pay using a credit card, debit card, or PayPal. Additionally, we provide a flexible layaway plan for those who prefer to pay for their purchase over time. If you have any questions about our payment options, please don’t hesitate to contact us.
Do you offer a money-back guarantee if I'm not satisfied with the service?
We offer a 30-day money-back guarantee. If you are not satisfied with our service for any reason, you can cancel within the first 30 days and receive a full refund, no questions asked.
Is there ongoing support or assistance available after my purchase?
Yes! At QSE Academy, our ISO experts provide continued support by answering your queries via email. You can expect a detailed response within 24 to 48 hours to help you move forward confidently.
Are updates to the documentation package included after purchase?
Absolutely. To ensure your documentation remains reliable and compliant, we update our packages every 6 months. Existing customers receive these minor updates at no extra charge. However, when there’s a major revision of the ISO standard itself, you’ll need to purchase an updated kit to align with the new standard.
Will I receive a valid invoice for my business expenses after completing the purchase?
Yes. After completing your purchase, you’ll immediately receive a valid invoice suitable for business and tax purposes. If you require any specific adjustments or details added to your invoice, please reach out to our support team.
Can I customize these documents for my company's specific needs?
Yes, the documents are fully customizable! You can easily edit, modify, and add your company’s logo to tailor them specifically for your organization. Additionally, if you’d prefer assistance, we offer a personalized “Done-For-You” customization service to deliver audit-ready documents tailored exactly to your organization’s requirements.
How quickly can I implement this ISO standard using your documentation?
Implementation time varies depending on your company’s engagement, resources, and experience. Typically, we’ve observed businesses successfully achieve compliance and certification within 3 to 6 months using our clear, structured documentation packages.
Do these documents guarantee successful certification?
While our documentation packages significantly simplify the certification process, the ultimate success of ISO certification depends on effective implementation. For organizations seeking further assurance, we also provide comprehensive support services, including guided implementation and internal audits, to help you confidently pass your certification audit.
Do you offer hands-on assistance if I need extra help during implementation?
Definitely! If you prefer a complete, hands-off solution, we offer a premium “Done-For-You” implementation service. Our ISO experts handle the full preparation, providing you with audit-ready documentation and detailed implementation support. You simply adopt the customized materials, follow the tailored guidelines, and confidently pass your audit.
