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
     

Quality Systems Manual


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 edit screen will open for a selected chapter.
 

Customer-related processes


Chapters include instructions on how to edit paragraphs.

Quality Manual is connected to business processes. In chapters where applicable, user will find drop-down menu that includes predefined processes and custom-made processes made according 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 process, linking is done.
 

Edit mode


When your Quality Manual is done, hit “Finish and Convert to PDF” button.  Finish and convert to pdf

Through automatic approval workflow, the document will be sent to CEO for approval.
 

Ceo dashboard

 

You won’t be able to finish your Quality Manual and convert 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.

After Quality Manual is approved by CEO, the QMS Manager will automatically receive task to review it and place the approved version to QMS Vault where it will be stored and locked for future references.
 

QMS manager dashboard


By default, Quality Manual will be saved within General Administration project in the Storage.

At any time, you can edit and update your Quality Manual.

While saving the revision of the Quality Manual, the QMS Manager can provide thedetails about each revision in the ‘File revision details’ window.

Provided details will be visible in the Storage Module in the ‘Details’in the ‘Revision’sectionunder the revision to which they refer