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.
This All-in-One Documentation and Training Package is our most popular product – for good reason: It gives you all you need to prepare for registration – including hands on guidance.
- 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.
The All-in-One Package includes everything else you need for certification:
- Complete Support
- Complete QMS
- 26 Procedures to cover every ISO 13485 requirement
- 45 Forms and Attachments
- 45 Page Quality Manual
- 13485:2016 QMS Procedures and Forms Matrix
- Includes Admin to assign and track users for record keeping
- Online Employee Training (25 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?
- Choose 13485:2016 to create a new 13485 Quality Management System
- Choose 13485:2003 to 13485:2016 QMS to modify your existing 13485 QMS to meet the 13485:2016 requirements
- Choose 13485:2016 FDA QMS Upgrade to develop an integrated management system that is 13485 and FDA compliant
- Choose ISO 9001:2015 to 13485:2016 QMS Upgrade to modify your existing ISO 9001:2015 to meet the 13485:2016 requirements
If you plan to reconfigure your existing quality manual completely by yourself, you can use either of the Upgrade Instructions to create everything on your own. They will tell you where to make the changes but will NOT provide any procedure or form templates for the new requirements.
|Price Each||ISO 13485:2016
|ISO 13485:2016 FDA All-in-One||ISO 13485:2003 to 2016 All-in-One||ISO 13485:2016 / ISO 9001:2015 Combined All-in-One|
|ISO 13485:2016 Quality Manual
(not sold separately)
|ISO 13485:2016/ISO 9001:2015 Combined QMS Manual
(not sold separately)
|ISO 13485:2016 Procedures||$300.00||26||27||26||24|
|ISO 13485:2016 Forms and Attachments||$100.00||45||47||45||60|
|ISO 13485:2016 Flow Charts||$75.00||23||23|
|ISO 13485:2003 to 2016 Upgrade Instructions||$99.00|
|ISO 13485:2016 to FDA Upgrade Instructions||$199.00|
|ISO 13485:2016 Gap Analysis Checklist||$39.00|
|ISO 13485:2016 FDA Gap Analysis Checklist||$59.00|
|ISO 13485:2016 Employee PowerPoint Training||$85.00|
|Requirements of ISO 13485:2016 PowerPoint Training||$85.00|
|ISO 13485:2016 Risk Management Exercise||$29.00|
|ISO 13485:2016 Internal Audit Checklist||$95.00|
|ISO 13485:2016 FDA Internal Audit Checklist||$95.00|
|ISO 13485:2016 Internal Auditor Training Materials||$495.00|
|ISO 13485:2016 Employee Newsletters||$75.00|