Consulting With a Personal Touch|Call Us: 832-326-9796

ISO 13485:2016 Quality Management System for Medical Devices Documentation Package Templates

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.

Price

$1,500

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

Documentation Review

Price: $300

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.

 

Implementation Checklist

Price: $150

Our proven implmentation checklist will provide a step-by-step guide to properly implementing your management system.

 

Online Implementation Support

Price: $900

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.

 

Certification Support

Price: $995

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.

Show Buttons
Hide Buttons