ISO 9001: 2015
The new version of ISO 9001: 2015, the most recognized and established Quality Management System in the world, has been published.
This revision of the Standard has been developed based on the technological changes and business challenges faced by companies, regardless of their size or sector.
The changes in the standard allow it to be useful and flexible enough to offer organizations not only a tool for quality management but also a management framework for business improvement through the incorporation of risk analysis And strategic processes within the Quality Management System.
Like other management standards, the implementation process of the Quality Management System is not a standard method, as it depends on the environment and stakeholders, as well as on the size of the organization, the activity it carries out and Of the products it manufactures or of the services that it performs.
In order to be able to implement a Quality Management System according to ISO-9001: 2015, the following steps have to be followed:
- Planning.- The context and stakeholders must be identified, as well as their needs and expectations, identify and evaluate the risks and opportunities inherent in the company's processes, define the quality policy, take into account legal requirements that may affect To the product or service performed by the company and define the objectives and goals to be achieved, in addition to establishing and implementing one or more action programs.
Implantation.- During the implantation process, it is necessary to take into account the resources in infrastructure, the measurement equipment, the responsibilities, training, sensitization and the necessary competence of the personnel, the communication, the documents that are part of the Management System Of Quality, control of such documentation, operational control of all operational processes.
At the same time, supplier purchasing and evaluation processes should be established, as well as the controls to measure the performance of outsourced processes.
In enterprises in which design activities are carried out, all input and output elements, as well as changes in design, must be controlled.
Verification.- Management indicators should be established and the results monitored and measured, nonconformities must be taken into account, corrective and preventive actions should be taken, records should be recorded and the necessary audits should be carried out to the Quality Management System.
Performance.- In the performance phase, as a consequence of the follow-up of the quality management indicators, actions must be identified and established that are aimed at the continuous improvement of the management system. The results of all the actions are analyzed in the review by the management, process that leaves the strategies and quality objectives that restart the PDCA cycle again.
The ISO 9001: 2015 standard, in force since September 2015, is the international standard that organizations must use for the implementation and certification of Quality Management Systems. In addition to companies that implement a new Environmental Management System, those that already have one, certified according to the previous version of the Standard (9001: 2008), must implement the requirements of the 2015 version in order to renew their certificate.
In September 2018, all companies certified in ISO 9001: 2008, must have adapted their Quality Management System to the new requirements of 2015, otherwise their certificates will no longer have value.
How to implement ISO 9001? .- With the collaboration of a team of experts in the implementation of Quality Management Systems, such as the consultants of Ecològic Girona, S.L. Which provide an integral, expert and professional service.
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