The implementation of a Management System commences with the delineation of its scope. Will it be applied to a specific set of activities, processes, or areas within the company? Or will it pertain to certain services and/or products?

Upon addressing these questions to delineate the Quality Management System, implementation commences with section 4 (Organizational Context) of the ISO 9001 Standard.

The sections' implementation must adhere to the order specified in the Standard, namely 5, 6, 7, 8, 9, and 10, for all processes identified within the Management System. These sections have been standardized by ISO, thereby facilitating future integration with other Management Systems, including the Environmental (ISO 14001) and Occupational Health and Safety (ISO 45001) standards.

This implementation must be executed by a team. It is advisable to establish a Committee or Working Group tasked with coordinating the implementation of the Management System.

A Coordinator is designated for implementation within the company, accompanied by one or more team members to oversee the coordination efforts throughout all implementation activities.

In addition to the Coordination team, the implementation team must encompass individuals specified in each mapped area or process, who fall within the purview of the Management System.

The organization may rely on a consultancy to oversee the entire process or specific aspects of the implementation, particularly if it aims to achieve Quality Management System certification. The certification phase will be addressed in the final section of this e-book.

A Management System is deemed implemented following the initial Internal Audit, the resolution of non-conformities, and adjustments to the QMS, as well as the first Critical Analysis of the System. All requirements of the ISO 9001 Standard, along with those established by the organization, must be fulfilled.

It is advisable to contract the initial Internal Audit or to ensure that no member of the Coordination team participates in the audit team. This inaugural Internal Audit is crucial for evaluating the extent of compliance of the QMS with the requirements of the ISO 9001:2015 Standard.

The approach to fulfilling the requirements of ISO 9001:2015 differs among organizations. The standard specifies "what" must be achieved; "how" it will be accomplished is contingent upon the size and structure of the organization.

A “separate” system should not be established; rather, if the organization already possesses effective practices prior to implementation, those practices should be adopted to fulfill the requirements of the Standard, without instituting “ISO 9001 meetings” within the company's routine. Typically, existing process control systems can be utilized, for instance, without the need to “create or invent” an additional system.

We have developed a guide containing knowledge accumulated over more than 18 years of experience in the implementation and maintenance of Management Systems. This material was created to be used as a guide for implementing a Quality Management System based on the ISO 9001:2015 standard in any organization. It includes a chapter on the Certification Stage for those organizations wishing to go through the certification process with a Certification Body.

Each section of the ISO 9001 standard is presented with its requirements and a list of the main tools that can be used to implement the requirements.

Managers, leaders, and students will be able to apply the knowledge gained from this ebook in their organizations and use it as supporting material in their learning in the field of Quality Management.

If you are not familiar with the ISO 9001 standards, this ebook is a great option to start in the area of Quality Management. All this will cost less than a full meal.

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