This site has moved to the integrated Appfire documentation and information site for our apps.
From February 2024 this site is no longer updated.
Take a look here! If you have any questions please email support@appfire.com
Comala Document Control ISO 9001 Section 4 (Quality Management System) Compliance Statement
Version 1.0
Confluence is a knowledge and document management platform that can manage files i.e., attachments. By utilising the different ways Confluence can manage attachments it can be used as a knowledge and document management platform. Attachments are files that are included with a page. Confluence lets you control who can add new attachments and who can open attachments on the space level. Once you attach a file, you can provide a link to it from any Confluence page or display a list of attachments for that page. If you attach a file with the same name as an existing attachment, Confluence will create a new version of the existing attachment.
The wiki allows all documents to be stored in a place where everyone can view and review them.
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 4 (Quality Management System) Compliance Statement
Comalatech 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.
Â
A. ISO Requirements
No. | Requirement | Description (paraphrased) | Satisfied by | ||
---|---|---|---|---|---|
Confluence | Comalatech Tools | Customer | |||
4 | Quality management system | ||||
4.2 | Documentation requirements | ||||
4.2.1 | General | The QMS documentation must include:
| Confluence allows users to store documentation in pages and attachments. Confluence tracks the history of changes to each page, keeping all versions. | The organization must provide the proper documentation. | |
4.2.3 | Control of documents | The organization must establish a documented procedure to define the controls to:
| Confluence unambiguously identify and stores changes, which can be recovered, compared or roll backed in any moment. Confluence wiki capabilities promote collaboration and peer-review processes, together with automatic notifications of changes ensure prompt content review. | Comala Document Control provides capabilities to ensure reviewing and approval of documents. | The organization must ensure that external documents keep the same process. The organization must define an appropriate workflow, specifying where approvals are required. |
4.2.4 | Control of records | Records provide the evidence of conformity with ISO 9001 requirements, so the process must be controlled. The organization must establish a documented procedure to define the controls for the identification, storage, protection, retrieval, retention and disposition of records. | Confluence ensures only authenticated user have access to system content, the definition of users and groups ensures the access to content based on those groups. In addition, records are safe because all versions are saved automatically. | Comala Document Control maintains control of the approved version of each document, and can control which version of the document is available to each user, based on their role. | The customer must control the access to the physical storage devices. |
5 | Management responsibility | ||||
5.1 | Management commitment | Top management must show evidence of its commitment to this process by:
| Confluence can notify with emails to whoever needs to know the changes, communicating immediately to the proper roles. | The company's top management staff must ensure the fulfilment of the quality in objectives and policies. | |
5.3 | Quality policy | Top management is responsible to establish a quality policy, which must:
| Confluence allows the communication of the documents to the members of the organization, allowing its revision and continuous improvement. | Comala Document Control enables the approval of documents. | The company's top management staff must create the quality policy. |
5.4.2 | Quality management system planning | Top management must ensure:
| Confluence keeps the integrity of the data. Links and page titles are automatically updated when there are changes. | Top management must review the QMS planning. | |
5.5.1 | Responsibility and authority | Top management must ensure that responsibilities and authorities are defined and communicated to the organization e.g., job description and organizational charts | Confluence provides a people directory and each person has a personal profile. This profile shows the position, department and personal data. Besides that, each user can maintain a personal space. Thus, all responsibilities can be communicated. | Top management must ensure that staff have an updated job description and can provide an organizational chart. | |
5.5.2 | Management representative | Top management must appoint a member of the organization to be "Management representative", who has to:
| Comala Share It provides a unique public link that can be shared outside Confluence to communicate with external parties. | Top management must choose a capable management representative. | |
5.5.3 | Internal communication | Top management must ensure that the communication processes are established, also regarding the effectiveness of the QMS. E.g., meeting reports are an evidence. | Confluence is a social tool used for internal communication, allowing content creation, comments and likes on the content, personal blogs, etc. | ||
5.6 | Management review | ||||
5.6.1 | General | Top management must review the QMS, at planned intervals, to ensure:
Records of this review must be kept (4.2.4) | Confluence simplifies content reviewing by the use of recent changes, page history, subscription to content changes in your favourite spaces or network. | Comala Document Control provides a 'Content Expiry Workflow' where approved content automatically enters an expired state after a set period of time. | Top management must ensure the revision of the QMS. |
5.6.2 | Review input | This review must include:
| Confluence provides different kind of pages to publish the inputs: meeting notes with control of attendants, how-to articles, product requirements, reports, pages, retrospectives, decisions, task lists, links, etc. | Comala Boards provides different kind of pages to publish the inputs: task boards or strategy canvas. | |
5.6.3 | Review output | The output must include decisions and actions related to
| Confluence provides different kind of pages to publish the outputs: meeting notes with control of attendants, how-to articles, product requirements, reports, pages, retrospectives, decisions, task lists, links, etc. | Comala Boards provides different kind of pages to publish the outputs: task boards or strategy boards. Alternatively, Comala Publishing provides a solution to separate approved from draft content in distinct spaces. | |
8 | Measurement, analysis and improvement | ||||
8.2 | Monitoring and measurement | ||||
8.2.2 | Internal audit | The organization must carry out, at planned intervals, internal audits to determine if the QMS:
Considering:
Internal auditors must be trained and competent and cannot audit their own work. | Confluence allow users to create visual roadmaps for planning audits, add-ons exist to create forms, everything can be printed and signed in case it needs to be send physically. | The Comala Document Control QMS workflow requires that approvers are specified Comala Share It allow users to externally send pages once the internal audit is finished. | The organization must ensure the training of the internal auditors. |
8.3 | Control of nonconforming product | The organization must ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The organization must establish a documented procedure to define the controls and responsibilities and authorities for dealing with nonconforming products, which includes:
| Confluence provides a product requirement, decision and meeting notes kind of pages to keep track of the customer product requirements, meetings and decisions derived from them. Thus, nonconforming products can be identified. | Comala Document Control allow users to set a workflow to control the state of the different pages involved on the documented procedure. | The organization must ensure the proper workflow setting and roles involved on the documented procedure. |
8.5.2 | Corrective action | The organization must establish a procedure to define:
| Confluence tasks can be used to indicate actions and areas to be improved by team members. Confluence capabilities could be improved if used together with Atlassian JIRA for doing so. | Comala Document Control consolidates document creation and modifications with the approval and signing audit records. A time-stamped log of workflow operation actions is also maintained, and associated with each document. | The organization must ensure the proper workflow setting and roles involved on the documented procedure. |
8.5.3 | Preventive action | The organization must establish a procedure for:
| Confluence tasks can be used to indicate actions and areas to be improved by team members. Confluence capabilities could be improved if used together with Atlassian JIRA for doing so. | Comala Document Control consolidates document creation and modifications with the approval and signing audit records. A time-stamped log of workflow operation actions is also maintained, and associated with each document. | The organization must ensure the proper workflow setting and roles involved on the documented procedure. |
Note: this list is based on "Achieving ISO certification", Iso requirements and "Using Document Control Software to Meet ISO Document Control Requirements"
Find out more...
For more information contact us at support@comalatech.com or directly to our support system at https://comalatech.jira.com/servicedesk/