Quality Systems Manual

The “Quality Systems Manual” Editor contains two parts:
 

1. Chapters - derived from ISO 134185:2016 Standard: Medical devices – Quality Management Systems – Requirements for regulatory purposes, on the left side menu and
    
2. Quality Systems Manual editor at the main part of the page
    

Chapters:

Cover Page

Introduction

1. Scope
   1.1. General
   1.2. Applications and exclusions
   1.3. ​Quality Policy Statement
    
2. Normative reference
    
3. Terms and definitions
    
4. Quality management systems
   4.1. General requirements
   4.2. Documentation requirements
   Related Processes
    
5. Management responsibility
   5.1. Management commitment
   5.2. Customer focus
   5.3. Quality policy
   5.4. Planning
   5.5. Responsibility, authority and communication
   5.6. Management review
   Related processes
    
6. Resource management
   6.1. Provision of resources
   6.2. Human resources
   6.3. Infrastructure
   6.4. Work environment and contamination control
   Related processes
    
7. Product realization
   7.1. Planning of product realization
   7.2. Customer-related processes
   7.3. Design and development
   7.4. Purchasing
   7.5. Production and service provision
   7.6. Control of monitoring and measuring equipment
   Related processes
    
8. Measurement, analysis and improvement
   8.1. General
   8.2. Monitoring and measurement
   8.3. Control of nonconforming product
   8.4. Analysis of data
   8.5. Improvement
   Related processes

You can select any chapter you want to edit. Selecting the chapter will open that specific one with the list of all related paragraphs.

Editing a chapter is easy. Move the cursor over the paragraph, it will turn pink, click on it, and the edit screen will open for a selected chapter.
 

Chapters include instructions on how to edit paragraphs.

Quality Manual is connected to business processes. In chapters where applicable, the user will find a drop-down menu that includes predefined processes and custom-made processes made according to the company’s specific workflow in Process Editor.

Note: You can insert only approved and active custom-made processes in the Quality manual.

When you select the process, linking is done.
 

You won’t be able to finish your Quality Manual and convert it to PDF until all chapters are adjusted to your company’s needs. You can exit from the Quality Manual Creator anytime and come back to finish it.
When your Quality Manual is done, hit the “Finish and Convert to PDF” button.  

"Attach approval workflow" window will pop up. You need to choose approval workflow from the list and click "Attach":

Then, "File revision details" will pop up, and you need to write what is changed in Quality Manual.

Your Quality Systems Manual is now exported to PDF and saved in General Administration Project.

You can click on the "Back" button and it will take you to the "Quality System Manual" previous page (for editing), or you can choose "Preview file here", and it will take you to the "General Administration" project in the Storage (Document Management).

User (or users, depending on approval workflow that you choose) who needs to approve the document will receive that request on Dashboard, section "Approvals - Waiting for me"

When approving a document, you must also write some details about your choice:

Quality System Manual is now approved, and you can check in the General Administration project / Storage module.

Now, the file can be moved to QMS, and then to QMS Vault if it is required.

Details will be visible in the Storage Module in the ‘Details’: