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How fulfil the standard ISO 9001

Written by Gaspar Palmer on 07 March 2017

In quality management, documentation is the basis for understanding the system, communicating the processes and their requirements within the organization and determining the effectiveness of its implementation.
ISO 9001 is defined as the set of interacting related activities, which transform input elements into results. The processes of an organization are generally planned and implemented under controlled conditions to bring value.

OpenKM provides this controlled environment, incorporating value when implementing the necessary processes to obtain results, according to the requirements of the clients and the policies of the organization.

Bear in mind that the use of a software tool - OpenKM or any other - does not guarantee de facto compliance with any ISO standard. What OpenKM allows is to facilitate compliance with the ISO-9001, using the tool in a certain way in coherence with what is established in ISO-9001 and with the objective of its fulfillment.

In this article we will show you an example of implementing a quality management system in a training department.

Previous situation

The organization manages the ISO requirements of the procedures in paper. These printed procedures are distributed among the affected persons, with an attached control sheet; which they must sign, to verify that the employee is aware of the new process.

The constant expiration and updating of procedures means the need of a training department for the management of training and up-to-date training courses. It manages also the record of attendance to the courses and records the individual file of each employee.

The organization, in its audits generates reports of corrective and preventive actions (CAPA) where the detected nonconformities are recorded. Subsequently, the log of deviations is generated and an individual report is created for each deviation.

Scope

Creation of a collaborative and secure environment that allows personalized access to documentation; the application of the procedures, the automation of the processes and the creation of reports that facilitate the audits, improving the detection and analysis of the nonconformities.

Quality implementation process

There are interviews with the department of quality management systems. It is an area of transversal scope within the organization. Representatives from training department will be present at these interviews.

The Training department will make available to the staff the Annual Training Plan in read only mode. Only the personnel assigned to the training department, will have the right to runs the privileges of edit, delete, set the security of the item, or manage the downloads control.

In turn, they will be the only ones who have access to the Forum and Wiki extensions. Forum gives them the possibility to discuss and obtain answers to subjective aspects that affect the procedure. And in the Wiki extension they can clarify and consult the bibliographic sources used to generate and update the procedures; as well as links to technical documents.

  

OpenKM from the History tap makes easy to access different versions of the document. When the final stage is reached, the official document is subject of a workflow in which the document, after being approved and signed, becomes visible and is notified to employees.

The Training department will create a record per employee, in which the user will have access to his personal training plan. The employee will use the Subscription Service to their training folder; In this way they will receive notification about any content updates; Establishment of course dates, teaching materials, etc.

 

In turn the Training department reserves the right to send notifications, whether at individual, group or departmental level to keep the staff informed. On the other hand, they can maintain fluid contact with all users through the OpenKM online chat.

 

The meetings, start dates courses and various training events, will be communicated and shared with the people affected, through the Task Manager feature. The organiser will provide access to the necessary documentation, and will inform about the meeting place either physical or virtual considering that OpenKM offers videoconferencing functionality.

On a regular basis, the training department will use the Reports feature to facilitate the follow-up of the training sessions attended by the staff.

Workflows will be very important in the ISO 9001 implementation . It guarantees the fulfilment of the process in all its phases; creating a univocal channel, in which the information passes from one phase to another, only when the stipulated requirements have been fulfilled.

OpenKM provides a default workflow engine, without additional cost. It is 100% flexible and adaptable. In the OpenKM Knowledge Center and in the OpenKM Youtube Channel, you will find free the Workflow Course that explains how to use the program of flowcharts and how to create our own Wokflows. For those organizations that do not have technical capacity, OpenKM can offer such consulting services.

The quality department will create the structure of workflows necessary to implement the quality policy.

It will also use the report feature, which in this case will be managed by an automatic task. Thus periodically, quality managers would receive reports with indicators of nonconformities, detected by the quality system.

This information, collected automatically by OpenKM, facilitates the work of internal audit. The task of internal control and analysis leads to the creation and publication of the CAPA Reports.

The organization can provide information through the KCenter extension to its clients, suppliers, auditors and various stakeholders. In accordance with the standards and current law, its clients and external auditors must be informed about the follow-up of the ISO 9000 quality management system.

Result

The organization enjoys a flexible technology that adapts to its present and future needs.It has achieve to managed and automate electronically all the tasks in the training area.

The department, has finished with the documentation in physical format.

Your customers and target audience enjoy personalized and exclusive access to the information and documentation they need through KCenter.

The quality department has managed to implement the quality management system throughout the company.

Through OpenKM, the organization:

  • Ensures compliance with quality policies.
  • The execution of the stipulated plans.
  • The verification of the results.
  • And the analysis and implementation of the necessary measures to correct deviations, in the next cycle.

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