When, as an external consultant, you need to organize the process of ISO 9001 certification for a company, there are several activities to carry out. It starts with the initial analysis and assessment of any gaps in relation to the standard. A systematic collection of all information related to business processes will be done, as well as a review of existing documents, from policies to operating procedures, in order to obtain a clear and detailed overview of internal operations and current quality management practices.
This collection of information will be followed by a critical analysis of the existing practices in relation to the ISO Standard requirements to identify areas where the organization does not meet the standard.
Next, it will be determined what resources are needed to address the identified gaps. These resources could include the need for training, purchasing new technologies, hiring new people, or other measures. The resource planning should be realistic and aligned with the company’s long-term goals. With the information collected and the analyses performed, the consultant should develop a detailed action plan with specific phases to adjust the existing system to ISO 9001, including clear deadlines, responsibility assignments, and indicators to monitor progress.
After completing the initial analysis and assessing the needs, the next step in the ISO 9001 certification preparation process as a consultant is designing the quality management system. The first task related to designing the system is the clear definition of quality objectives that should closely align with the company's vision and mission, ensuring that the system is integrated with the company’s overall objectives.
Quality policies will be the foundation of the system as they must reflect the organization's commitment to quality and customer satisfaction. They should be written clearly and concisely and must be easily accessible at all levels of the organization, as well as communicated effectively to all personnel. Once the objectives and policies are established, it will be necessary to design detailed procedures that describe the daily activities that will support the objectives over time. The final aspect of designing the system is assigning responsibilities. Each process and procedure must have an identified person responsible for its implementation, monitoring, and continuous review.
Once designed, the Quality System must be implemented correctly. The introduction of a new quality management system must be carefully planned because it will include, among other things, the planning of training for staff covering all aspects of the ISO 9001 standard and the company-specific quality management system. Training should not be one-size-fits-all but tailored to the specific needs of different groups within the organization. In addition to training, informational sessions should be organized to ensure everyone is aware of the changes and their role within the system.
Regular meetings may be held, and an internal platform could be organized where staff can find resources, ask questions, and share feedback. At this stage of the project, it is also important to recognize and reward employees who demonstrate exceptional commitment to the implementation and maintenance of quality, as this can have a significant impact on the motivation of all staff. Encourage staff to provide feedback and to be proactive in suggesting improvements. Employee involvement is not only a requirement of ISO 9001 but is also a key element in creating a corporate culture that values quality.
In the implementation phase of the system, special attention must be paid to resistance to change, which is quite common during the implementation of new projects.
After completing everything we have seen, the consultant will be ready to prepare the organization for the third-party audit, the certification audit. This will begin with monitoring and evaluating the system to ensure that the organization not only meets the established standards but also continues to improve over time. This phase allows for the collection of data on system performance, identifying areas for further improvements, and ensuring that quality objectives are met.
At this stage, indicators will be evaluated, and data will be reviewed. An important aspect of this phase is conducting audits, which are also tools in the monitoring process. Audits help verify that processes comply with documented procedures and ISO 9001 requirements. If problems are identified during the monitoring phase, corrective actions will need to be implemented.
Finally, we reach the certification audit. This phase requires meticulous attention to detail and proper preparation to demonstrate compliance with quality requirements. Start by establishing clear and proactive communication with the certification body, ensuring that you understand the audit schedule, timing, focus areas, and specific requirements. Prepare everything necessary at the logistical level, such as spaces for interviews and meetings, and access to documents.
The certification audit preparation requires the joint commitment of all staff and careful management by both management and the external consultant. Proper preparation increases the chances of success in obtaining certification and also strengthens the quality culture within the organization. Begin the audit with a welcome session for the external auditors. Provide an overview of the organization, the quality management system, and the objectives to clarify any preliminary doubts the auditors may have regarding the organization.
Ensure that all staff are available to answer specific questions related to processes and individual responsibilities. After the audit, make sure to understand all observations and recommendations and organize an internal meeting to discuss the results and plan the necessary corrective actions.