The implementation of a quality system in any company should not become a traumatic process, rather it should be understood as a great opportunity for growth and development.
The following are some of the generic steps to apply when implementing an enterprise quality system:
Management decision and commitment
It is the most difficult condition to achieve, because normally the company has an ingrained culture that is hard to change because it has been established and stimulated by the same management
This commitment must be visible and demonstrated in all the actions you take on a daily basis. This step is of such importance that it is not convenient to start the implementation of the ISO 9000 quality system until senior management is convinced that this is a need and feels committed to carrying it out, getting involved in each of the phases of the process. process.
Selection of the contractual model applicable to the company (ISO 9001, ISO 9002 OR ISO 9003)
After having made the decision to work under the guidelines of the ISO 9000 standards, it is necessary to determine the applicable contractual model.
This requires determining what the main activities and functions of the business are.
- ISO 9000: Companies that design and manufacture the products they sell. ISO 9002: Companies that manufacture, install the products and offer the service. ISO 9003: Supplier must only ensure quality through inspection and testing
Quality system diagnosis
Next, a study or diagnosis of the current state of the quality system is carried out to serve as a starting point for the actions to be taken for the implementation of the ISO.
It is intended to determine the strengths and weaknesses, as well as the obstacles that may arise.
To collect the information, the following methodology can be followed:
- Interviews: Directed mainly to senior management to learn about the organizational climate and to union representatives to find out their disposition and attitude towards company processes. Observation of the processes: To investigate the operational processes it is important to structure a guide that contemplates the collection of the minimum necessary information by department.
- Marketing and sales Quality assurance Production and Maintenance Human resources Finance
- Review of records: in order to verify the information that has been provided in the previous phases. Opinion questionnaires: When it is necessary to supplement the information.
At the end of the diagnosis, the final report is made, which is a document to be constantly consulted and to review the progress made. In addition, this will allow to determine the areas where it will be necessary to make the greatest efforts.
Steering committee formation
The implementation of the continuous improvement process under the guidelines of the ISO 9000 standard requires an organization that plans and directs all the actions that they want to undertake. This committee must be made up of the president or general manager, in addition to all the directors who report directly to him.
Establishment of action plans
To establish the action plans to be followed in each of the clauses of the standard, as well as to facilitate the monitoring and progress of the process, the use of a document for monitoring activities is recommended for each clause, where the person responsible for activity, start and end date, as well as estimated progress.
Another document that is recommended is that of activities or tasks to be developed in each clause of the standard. In this format, the person responsible for implementing the clause indicates step by step all of them to be developed until they are fully implemented.
Other aspects to be considered are the application of safety regulations, as well as the identification and elimination of unsafe conditions that may exist in the company.
Likewise, the start of a quality cost system must be planned that allows to identify and quantify the costs of waste as well as what is invested in preventive actions.
Review and preparation of system documentation
To prepare the documents corresponding to the quality system, all the processes that affect the quality of the product or service are identified and a flow chart is prepared for each of them, determining the documents required for each activity to guarantee the proper functioning of the process.
Within these documents are quality plans, procedures, work instructions, quality records and others.
Based on the analysis carried out, existing and missing documents are determined, establishing action plans for their preparation.
Preparation of the quality assurance manual
This is the last document to be elaborated in the documentation system, it is used as a marketing weapon, where the way in which the company has established a system that meets each of the requirements of the ISO 9000 standard is indicated, to guarantee the products it offers.
The quality assurance manual is structured following each of the clauses corresponding to the applicable contractual document.
Process of certification
When the company's management considers that the quality system is already adequate to the requirements of the applicable contractual model, it requests from the certifying body to start the certification process. In each country there is a certifying body, it is before it that the respective procedures are carried out.
