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This article explains how compliance with section 7.5 of ISO-19001:2015 can be achieved when using Confluence with Comala Document Control. 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 tracking of what changed in each document, when, and by whom. Team members can create, share, and collaborate on content.

If your organisation 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 organisation is aligned well with many of the overarching objectives of the standard: i.e improved communications, decentralisation of quality processes, knowledge sharing.

Extending Confluence with Comala Document Control 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 Control. It also provides information about support for other elements of the standard, and a list of the tools required for successful implementation.

If you require the capability to customise your document workflow or structure your content into 'authoring' and 'published' spaces, see Comala Document Management ISO 9001 Section 7.5 (Document Control) Compliance Statement

Table of Contents

- 1.1 Need Help?
2 1. Checklist against the ISO 9001:2015 requirements of section 7.5 (Documented information)
3 2. Tips on how Confluence and Comala Document Control can reinforce ISO 9001:2015 processes

Appfire 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.

Need Help?

Need help setting up Confluence and Comala Document Control for controlled documents? Contact Us.

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
		Comalatech 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: Identified and described Reviewed and approved	Comala Document Control provides a way to enforce a review and approval process for documents using configurable workflows. This approval process is supported by built-in electronic signatures and an audit log.	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: Available to users; Protected (from loss, misuse)	Comala Document Control provides the means to clearly distinguish between current and draft versions of documents.	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	Users need to be able to access and use the documentation; Documents need to be preserved; and dispositioned Apply change control; Certain external documentation should also be controlled	Comala Document Control 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 Control 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)	Implement backup policies. Block Confluence pages from being deleted (through access management).

2. Tips on how Confluence and Comala Document Control can reinforce ISO 9001:2015 processes

2.1 Improved communication (ISO 9001:2015 sections 7.4, 8.2.1, 8.4.3)

The ISO 9001:2015 requires a conscious effort to establish good communication channels:

from the management to the entire organization;
toward customers, i.e in regard to your products and services;
with your suppliers.

Confluence can be a key pillar in your communication strategy. It provides a friendly, modern environment to share documents. Moreover, it has some key features to promote effective communication. For example:

Out of the box it offers a daily digest where users may be notified about changes on pages in a compact and non-spammy manner.
Confluence pages come with support for bi-directional communication; (permitted) users may comment on pages, share with colleagues or start a whole discussion in a forum that is related directly to the page. This helps cultivate a culture where feedback can be given by anybody in the organization.
Confluence comes with a powerful search engine.

2.2 Organizational knowledge (ISO 9001:2015 section 7.1.6)

From its very start, Confluence has been widely used to capture and share organizational knowledge. In particular, some of the built-in page templates are specially designed for that, i.e.: the built-in templates ‘How-to-articles', and 'Troubleshooting articles'. Making Confluence available to everyone and providing your team with the context and space to record their knowledge can, over time, create a rich reference that your team can rely on.

2.3 Awareness, competence and training (ISO 9001:2015 sections 7.3, 7.2)

Comala Document Control can be used to support a training-related workflow. Users can then be assigned to confirm that they read a certain page, and this confirmation is recorded on the page.

2.4 The toolset required to set-up a document management system on Confluence

The following table shows the typical set of tools used by companies that maintain their Quality Management System in Confluence :

Component	Role

Component

Role

Confluence

The platform for creating, storing and using the documented information.

Comala Document Control

An Appfire Comala app for Confluence which provides a way to enforce an approval process for documents using configurable workflows. This approval process is supported by built-in electronic signatures and an audit log.

Secure infrastructure

Provide a secure platform, where only authorized users are accessing and modifying the data.

Backup facilities.