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Comala Document Management Cloud ISO 9001 Section 4 (Quality Management System) Compliance Statement



Comala Document Management Cloud ISO 9001 Section 4 (Quality Management System) Compliance Statement

Document Version

0.2 

Confluence is a knowledge and document management platform that can manage files i.e., pages and attachments.

By utilising the different ways Confluence can manage pages and 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 creates 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.

Table of contents

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.

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Need help setting up Confluence and Comala Document Management for controlled documents? Contact us.


A. ISO Requirements

No.

Requirement

Description

(Paraphrased)

Satisfied by

Confluence

Appfire Tools

Customer

4. Quality management system

4.2 Documentation requirements
4.2.1 General

The QMS documentation must include:

  1. Organization’s Quality Policy and Quality Objective

  2. Quality Manual

  3. Documented Procedures and records required by ISO 9001 QMS

  4. Documents and records, determined by the organization to ensure the effective planning, operation and control of its processes.

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:

  1. approve documents before being released,

  2. ensure that new version of documents are reviewed and approved before being released,

  3. ensure that changes and revisions are identified,

  4. ensure that versions of documents can be recovered when necessary,

  5. ensure that documents remain legible and identifiable,

  6. ensure that external documents determined by the organization keep the same process, and

  7. prevent the unintended use of obsolete documents and identify them.

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 Management provide 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 Management 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.

Alternatively, Comala Publishing provides a solution to separate approved from draft content in distinct, separate spaces.

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:

  1. Communicating to the organization the importance of meeting customer, statutory and regulatory requirements,

  2. ensuring that the quality policy is established,

  3. ensuring that the quality objectives are established,

  4. ensuring that the management reviews are conducted, and

  5. ensuring that the resources needed are available. 

Confluence can notify with emails to whoever needs to know the changes, communicating immediately to the proper roles.

Comala Document Management can set tasks to be fulfil by specific roles.

The company's top management staff must ensure the fulfilment of the quality in objectives and policices.