An ISO 9001 Lead Auditor as well as the Quality Management System implementer must clearly understand the difference between quality management, quality assurance and quality control.
Let us see how ISO 9000 “quality management systems— Fundamentals and vocabulary” defines these terms:
- Quality Management – management with regard to quality.
- Quality Assurance – part of quality management focused on providing confidence that quality requirements will be fulfilled.
- Quality Control – part of quality management focused on fulfilling quality requirements.
In the image, you will see how these aspects of the system are all important and play their own role in ensuring that the focus on customers is met and the organization is delivering conforming products/services. Where internal auditors have not received beneficial ISO 9001 Lead Auditor training there may be a tendency to dictate how the system should function. This is nor the role of the auditor/assessor. The role of the auditor is to identify where non-conformities or opportunities for improvement may lie and then to allow the system to find the best corrective action.
At QMII we have experienced examples where quality control and quality assurance departments have built their own powerhouses. In these cases, each ends up battling the other to the detriment of the system and the customer. Quality Control is essential the function played by the inspectors that are working on the product realization or service delivery and are trying to catch faults to prevent them from going out to the customer. Quality Assurance is the role played by auditors and management appointees to ensure the system is working in delivering conforming products/services, meeting top management policy and objectives and continually improving. Audits are one of the tools that are employed for quality assurance. Well trained ISO 9001 Lead Auditors benefit the system here through their objective audits.
Quality Management is the overall management of both the assurance and control functions. It is here that leadership plays an important role by remaining engaged in the system to ensure its success. At QMII, we train our ISO 9001 Lead Auditor students to adequately facilitate management reviews so that they benefit the system and do not just become a paperwork drill.
Quality management systems when well-implemented must ensure that the entire organizations is engaged by leadership and working as a team to meet the requirements of the customer and the objectives of the system. The ISO 9001 Lead Auditor and quality control inspectors recognize the important while different role that each play in the system.