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Comala Document Control ISO 9001 Section 7.5 (Document Control) Compliance Statement
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 | ||
---|---|---|---|---|
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:
| 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:
| 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 |
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| 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 regards 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 which 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 especially 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 which your team can rely on.
You can read more about this here: https://confluence.atlassian.com/doc/use-confluence-as-a-knowledge-base-218275154.html
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 who maintain their Quality Management System in Confluence :
Component | Role |
---|---|
Confluence | The platform for creating, storing and using the documented information. |
Comala Document Control | A Comalatech 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. |