OUR PROCESS STARTS WITH YOUR PROCESS
We mold the ISO system around your day to day business, integrating new tools to assist in managing the quality management system without making unnecessary changes.
We mold the ISO system around your day to day business, integrating new tools to assist in managing the quality management system without making unnecessary changes.
Medi Invest Group will conduct an on-site visit to your facility meeting with your process owners. During this meeting we will ask the process owner to define their process in great detail. During this definition we will be comparing your current process to the quality management system requirements. In a DETAILED report we will identify the gaps between your process and the quality management system requirements; along with the gaps we will identify the resources (procedures, training, implementation, etc...) to fill these gaps.
Working with your department managers and process owners; Medi Invest Group will determine the best method to control your processes. We will identify if procedures are required or recommended, in addition what training will be required to ensure the process is working effectively,efficiently and systematically. We will also be determining measurable objectives for each process so that the management team will be able to review current and accurate data to identify if the process is meeting their expectations.
Medi Invest Group will generate a training matrix and training plan to be implemented by your company. Based on the process controls employees will need to be introduced and/or made aware of the control mechanisms implemented around their processes.In addition each employee will need some basic information about ISO 9001 and their role in assisting the company in achieving,maintaining and continually improving the ISO 9001 Quality Management System.
Once the training has been completed and the processes controlled. The company will need to begin generated quality records to support the processes. Once enough time has elapsed and enough records generated to support the process, Medi Invest Group will conduct a detailed internal audit to determine if the Quality Management System is operating as planned. Medi Invest Group will conduct the internal audit in the same manner as a Registration Firm would conduct their registration audit. This allows the employees to become familiar with the audit process and to get used to answering question related to their process and measurable objectives. The internal audit is complete with a detailed report, checklist and audit findings that are provided to the management team so that they can drive the continual improvement process.
The ISO 9001 standard requires that the organization conduct periodic management review meetings. During this meeting the management team will review data from their quality management system to determine if the system is effective. Medi Invest Group will chair the first meeting to allow the management team to become familiar with the process and the agenda items that need to be discussed.
Know that all the ISO requirements have been addressed, implemented, audited and reviewed, it is time for the company to be audited by a certified body. Medi Invest Group will attend this audit as a supporting function to the company. Once the audit is complete the company will be recommended for certification and the audit results will be reviewed by a review board once approved the company will receive their ISO certification thru the mail and at that time the company can publish the fact that they have achieved ISO certification.
Getting ISO certified is often the easy part. Maintaining the system and continual improving the system is sometime the part that seems to lag for some companies. If the system is set up correctly during the initial phases of implementation,the maintenance should be part of the day-to-day activities. But if the system is set up to basically pass the registration audit and not to be used for improvement than the system seems to become dormant once the registration audit is complete. It is important that the management team focuses on the corrective and preventive action system along with the internal auditand management review processes. These processes are the most important improvement tools within the ISO Quality Management System.