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Comala Document Management ISO 9001 Section 7.5 (Document Control) Compliance Statement



Comala Document Management ISO 9001 Section 7.5 (Document Control) Compliance Statement

Document Version

1.1

This article explains how compliance with section 7.5 of ISO-19001:2015 can be achieved when using Confluence with Comala Document Management. It also provides information about support for other elements of the standard and a list of the tools required for successful implementation.

Confluence is a documentation tool used to help teams collaborate and share knowledge efficiently. It acts as your home for document collaboration and acts as a repository as it keeps full track of what changed in each document, when, and by whom. Team members can create, share, and collaborate on content. 

If your organization has an ISO-19001:2015 quality management system, you can leverage Confluence to meet many of the requirements of that standard. In fact, we believe that using Confluence across your organization is aligned well with many of the overarching objectives of the standard: i.e improved communications, decentralization of quality processes, and knowledge sharing.

Extending Confluence with Comala Document Management will help you meet the requirements related to the management and control of documents (section 7.5, Documented information).

This article explains how compliance with section 7.5 can be achieved when using Confluence with Comala Document Management. It also provides information about support for other elements of the standard and a list of the tools required for successful implementation

Table of Contents

Appfire Comala does not claim compliance or certification of any of our tools, as it is not possible for any vendor to offer a compliant system. In addition to taking advantage of technical elements, compliant systems must also implement the necessary procedural and administrative controls.



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1. Checklist against the ISO 9001:2015 requirements of section 7.5 (Documented information)

Reference

Requirement (the original working is given in italics)

How to Achieve Compliance

Reference

Requirement (the original working is given in italics)

How to Achieve Compliance





Appfire Comala Apps

Confluence

Processes and activities

7.5.1

Certain documented information is required



QMS documentation is maintained in one or several Confluence spaces.

Create the required documents natively within Confluence, or attach external documents.

7.5.2

Documented information should be:

  1. Identified and described

  2. Reviewed and approved



Comala Document Management provides a way to enforce a review and approval process for documents. This approval process is supported by built-in electronic signatures and an audit log. The flexibility provided by the Comala Document Management macro language enables configuring an approval process which reflects your defined documented approval processes and the different organizational roles you have.

Each Confluence page has a unique Space/Title combination.

Page versions are captured automatically and provide comparisons between versions.

Unique page identifier may be allocated manually (i.e., using page properties or page metadata).

Define the review and approval process which works best for you.

7.5.3.1

Documented information will be:

  1. Available to users;

  2. Protected (from loss, misuse)



Comala Document Management provides the means to clearly distinguish between current and draft versions of documents. Some organizations go further and are using Comala Publishing to help separate between approved pages and pages which are still in the authoring and approval process. It creates a structure of an authoring space, where approved documents are automatically published into an official space.

Users can access Confluence throughout the internet (as per your network and security configuration) using any device.

Confluence provides facilities to limit the access to documents in a granular manner.

Use Confluence within a secure infrastructure. Implement policies for access management.

7.5.3.2

  1. Users need to be able to access and use the documentation;

  2. Documents need to be preserved; and dispositioned

  3. Apply change control;

  4. Certain external documentation should also be controlled



  • Comala Document Management provides the mechanism to change control each document (see explanation for 7.5.2 above).

  • For external documents: they can be attached to Confluence pages, and these pages then provide the control mechanism for the external document. Comala Document Management can then be used to approve each external document in a similar way to that of internal documents.



  • Confluence permission mechanism is granular enough to allow some users to have 'view only' access to documents.

  • Documents may be disposed by moving to a segregated area in Confluence (typically a space sub tree which is hidden from most users)