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

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 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.

The organization must ensure that external documents keep the same process.

The organization must define an appropriate workflow, specifying where approvals are required.

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.

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. 

Top management is responsible to establish a quality policy, which must:

1. be aligned with the organization's goal and quality direction,
2. commit to comply QMS requirements,
3. provides a framework to set and review quality objectives,
4. be communicated and understood by the organization, and
5. be reviewed in management review.

Confluence keeps the integrity of the data. Links and page titles are automatically updated when there are changes.

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 appoint a member of the organization to be "Management representative", who has to:

1. ensure that the processes needed for the QMS are established, implemented and maintained,
2. report to top management on the performance of the QMS and improvements,
3. promote the awareness of customer requirements in the organization, and
4. communicate with external parties regarding ISO 9001.

Top management must review the QMS, at planned intervals, to ensure:

1. its continuing suitability,
2. its adequacy and effectiveness,
3. opportunities for improvement.

Records of this review must be kept (4.2.4)

Comala Document Management allows the description of a workflow to review and approve documentation.

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 Canvas provides different kind of pages to publish the inputs: task canvas or strategy canvas.

The output must include decisions and actions related to

1. improvement of the effectiveness of the QMS and its processes,
2. improvement of product related customer requirements, and
3. resource needs.

Comala Canvas provides different kind of pages to publish the outputs: task canvas or strategy canvas.

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

Monitoring and measurement

The organization must carry out, at planned intervals, internal audits to determine if the QMS:

1. conforms to the ISO 9001 and the QMS requirements,
2. is effectively implemented and maintained.

Considering:

1. the status and importance of the processes,
2. the areas to be audited,
3. the results of previous audits,
4. the results from external auditors

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.

Comala Document Management can set tasks to specific users and ensure that auditors cannot audit themselves.

Comala Share It allow users to externally send pages once the internal audit is finished.

The organization must establish a procedure to define:

1. reviewing nonconformities, including customer complaints,
2. determining the causes,
3. evaluating the need to ensure that nonconformities don't occur,
4. determining and implementing the actions needed,
5. records of the results,
6. reviewing the effectiveness of the corrective actions.

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 Management 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 establish a procedure for:

Comala Document Management 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.