Use our All-in-One Implementation Package to lead your company to ISO 13485 Certification with confidence!
Your end product will be a quality system that works for you and helps your company continually improve its processes and customer satisfaction.
- Package has been used by companies across the globe since 2001
- Has never failed an audit
- Auditors love the efficient and effective design
- Major OEM’s and Registrars recommend our product!
- The documented Quality Management System (QMS) is organized for you. You won’t have to face a blank page or figure out what is required. Quality Manual, Procedures & Forms are fully written and ready for you to customize. They contain guidance so you know what to edit and examples are provided.
- You won’t need to hire consultants to develop your system or to train your employees.
- Our training will teach you the requirements of the standard and how to implement them.
- Train your employees in house. You can choose to train them yourself like a pro with the PowerPoint training complete with trainer’s guide and detailed speaker’s notes. Or, let your employees self-train with convenient online training.
- You’ll set up an effective audit program with trained internal auditors. An effective audit program is the key to success as it is the engine that drives continual improvement.
No worries! Have a question along the way? Ask the experts anytime throughout your project. Use the product that has been successfully used by thousands of companies around the world.
- All the documentation you need to document your QMS:
- All documents are in MS Word format for ease of editing and provide text to address each requirement of the ISO 13485 Standard.
- Required references to the recommended procedures and forms for your quality management system
- Intuitive numbering system for easy Document Control
- We’ve numbered the sections of the Quality Manual to correspond with the sections of the ISO 13485 Standard.Registrars LOVE this feature!
- Procedure and Form numbers relate to the section in the Quality Manual.
- Conveniently train employees in house with PowerPoint Training Presentation or online training.
- Gap Analysis Checklist gets you started on your project plan.
- Create a solid Audit Program – with RAB/QSA Compliant Materials
- Internal Audit Checklist Easy to use, easy to customize
- Internal Audit Plan and Forms for a complete package
- Guidance to set up a successful Internal Audit Program
- Train your Internal Audit Team – We’ve created interactive training materials modeled after the Certified Lead Auditor Program. You will audit a mock company, and discuss the findings with the students. This kit includes Auditing notes, Work Instructions, Corrective/Preventative Action logs, CAPA Requests, etc.
- This is a downloadable product.
- We offer Includes Technical Support throughout your project. We won’t abandon you after the sale.
- Complete Support
- Complete QMS
- 26 Procedures to cover every ISO 13485 requirement
- 43 Forms
- 45 Page Quality Manual
- Includes Admin to assign and track users for record keeping
- Online Employee Training (50 People)
- Introduction to ISO 13485 PowerPoint Training Package
- Internal Auditor Training Materials
- Guide to Internal Auditing PowerPoint (33 Slides)
- Requirements of the Standard PowerPoint (96 slides)
- Steps of an Internal Audit PowerPoint (34 slides)
- Comprehensive Trainer’s Guide (177 pages)
- Student Manual (89 pages)
- MedTech Mock Manufacturing Company Case Study Materials (48 pages)
- Internal Audit Forms to conduct the practice audit
- Customizable Certificate of Completion
- ISO 13485 Gap Checklist
- ISO 13485 Internal Audit Checklist
- Risk Management Exercise
- Employee Newsletters
Which version is right for me?
- Content coming soon
|Price Each||ISO 13485:2016
All in One
FDA All in One
|ISO 13485:2016 Quality Manual||$97.00|
|ISO 13485:2016 Procedures||$300.00||26||27|
|ISO 13485:2016 Forms & Attachments||$100.00||43||44|
|ISO 13485:2016 Templates (3)||$100.00|
|QMS Upgrade Instructions||$199.00|
|ISO 13485:2016 Gap Checklist|
|ISO 13485:2016 FDA Gap Checklist||$59.00|
|ISO 9001 to ISO 13485 Gap Checklist||$59.00|
|Online Employee Training||$400 (50)||Coming soon||Coming soon|
|Requirements of ISO 13485:2016 PowerPoint Training||$85.00|
|ISO 13485:2016 Internal Audit Checklist||$95.00|
|ISO 13485:2016 FDA Internal Audit Checklist||$95.00|
|ISO 9001 to ISO 13485:2016 Internal Audit Checklist||$95.00|
|Internal Auditor Training Materials||$495.00|
|ISO 13485:2016 Employee Newsletters||$75.00|
|ISO 13485:2016 Risk Management Exercise||$29.00|