ISO 13485:2016 Documentation Package
Writing documentation that meets management system requirements can be challenging for organizations of any size. If your organization is short on time or lacks the know-how of writing management system documentation, our documentation packages are a cost-effective solution to jumpstarting your implementation. Our carefully designed ISO 13485:2016 Certification Ready documentation package includes all required documents and forms to achieve certification with minor customization. These are not just cookie-cutter templates. Our documentation packages have been refined by management system experts with over 24+ years of experience.
Included at No Extra Cost
• Preliminary Customization
• Logo Placement and Branding
• (2) Complimentary Conformance Manager Concurrent Licenses. $480 Value. Click here to learn more about our management system software.
Documentation Package Contents
Level 1 Policies and Manual
1. Quality Policy
2. System Manual
3. Quality Objectives
Level 2 Processes and Procedures
4. Control of Documents
5. Control of Records
6. Internal Audits
7. Control of Nonconformities
8. Corrective and Preventive Actions
9. Personnel Training and Competency
10. Review of Requirements
11. Risk Identification, Control and Contingency Planning
12. Purchasing Products and Services
13. Identification and Traceability of Products
14. Safeguarding and Preservation
15. Maintenance and Calibration of Equipment
16. Measurement of Customer Satisfaction
17. Analysis of Data Regarding Effectiveness of QMS
18. Management of Change
Level 3 Forms
19. Procedure Template
20. Nonconformity Register
21. Internal Audit Plan
22. Internal Audit Checklist
23. Nonconformity Report
24. Meeting Minutes Template
25. Management Review Minutes Template
26. Training Matrix And Register
27. Purchased Product Or Service Requirements
28. Physical Inventory Sheet
29. Employee Evaluation
30. Form Template (Landscape)
31. Form Template (Portrait)
32. Employee Suggestion And Feedback
33. Sign-In Sheet
34. Job Description Template
35. Supplier Evaluation
36. Controlled Document Register
37. Risk Register
38. Equipment Calibration And Maintenance Register
39. Customer Satisfaction Survey
40. Performance Monitoring Spreadsheet
41. Deviation \ Change Request
42. Action Confirmation
43. Employee Competency Assessment Record
44. Document Transmittal
45. Advisory Notice
46. Deviation \ Change Request Register
47. Case Report
Value Added Options
A technical writer will conduct a detailed review of your customized documentation, to ensure it meets management system requirements. Recommendations for improvements will be provided.
Our proven implmentation checklist will provide a step-by-step guide to properly implementing your management system.
Online Implementation Support
A management system consultant will guide you through implementation during (6) online, one hour meetings. Your consultant will provide support, training and answer questions to ensure proper implementation of your management system. Additionally, you will gain access to our online training video library to further guide implementation activities.
Onsite Implementation Support
Price: Request a Quote
A management system consultant will travel to your facility to guide you through a step-by-step implementation checklist during bi-weekly meetings. Your consultant will provide support, training and answer questions to ensure proper implementation of your management system. Additionally, you will gain access to our online training video library to further guide implementation activities.
Pre-Certification Audit Service
Price: Request a Quote
Our Certified Lead Auditor will conduct a pre-certification (internal) audit, to determine readiness for a certification audit. A report of findings and corrective actions will be provided to ensure successful certification. Performing an initial internal audit is required by certification bodies prior to the certification audit.
We will select an ANAB or UKAS accredited certification body that best fits your organization. We will complete the certification application and submit for your approval. Upon completion of the certification audit, we will assist in responding to any finding(s) during the initial certification audit, until certification is achieved. We will continue to be available via phone or email for 30 days upon achieving certification.
How to Order
1. Place order below.
2. Pay invoice.
3. Documents delivered.