QUALITY SYSTEM IMPLEMENTATION PROCESS
I. Organizational Context
AIM begins quality management system development with a Gap Assessment, comparing your company processes with the requirements of the standard and determining the gaps that need to be filled. Next, we work with your leadership team and process owners to analyze your organization's context. We consider your company's operating environment - identifying stakeholders, internal and external factors, and risks that may impact the success of your management system. From there, we help you define the scope of your QMS and your quality policy, key company processes, and their interactions. We understand that one size does not fit all. This process facilitates a customized Quality Management System tailored to the needs and size of your business.
AIM consultants will work with your team to determine the best way to control your business processes and implement the requirements of the standard. We will identify documentation and training requirements and help design procedures so that your management system can run effectively. Our consultants will help define measurable objectives for each of your key processes so that your management team can review and continually improve the effectiveness of your QMS processes. AIM's approach is designed for efficiency and simplicity.
IV. Internal Audits
Once training has been conducted and enough time has elapsed for quality records to be generated, AIM tests the functioning of the quality management system by conducting an Internal Audit. At this time, if your company plans to conduct its own internal audits, AIM will provide auditor training and certification. A detailed audit report including findings and opportunities for improvement is generated and provided to the management team. Root cause analysis training for NCR closure is provided. Corrective actions are generated and the continual improvement process begins.
III. System Implementation
During this stage, your QMS is formally released. AIM consultants will provide comprehensive training for all your QMS processes. Each training program is tailored to meet your current organizational and business needs. Employees will be trained on the control mechanisms implemented around their processes. All staff will receive ISO Awareness Training so they understand their roles and responsibilities and how they can help maintain and continually improve the Quality Management System. Even after training is completed and your QMS is live and generating records, your AIM consultant will be available to your team as needed.
V. Readiness Review and Continual Improvement
The standard requires periodic management reviews to analyze and evaluate the effectiveness of your QMS and its processes. During this meeting, your management team will analyze and evaluate internal and external issues, risks, supplier performance, quality objectives and KPI results. They will also identify resource needs and opportunities for improvement. AIM will chair your first management review meeting and help with data trending and preparation of agenda and minutes, so that you can become familiar with the process. After the Management Review, and about three weeks prior to your 3rd Party Registration audit, an AIM consultant will conduct a Readiness Review assessment. We will verify the effectiveness of corrective actions taken from internal audit, conduct mock audits, and provide additional coaching as needed.
Now that you have implemented, audited, and reviewed the ISO and/or AS9100 requirements, you are ready for the 3rd party certification audit. After completion of this audit, the registrar will recommend your company for certification, a review board will review and approve the recommendation, and you will receive your certificate!
AIM’s process ensures successful certification. Organizations who follow our proven methods are ensured successful certification. But the impact of your management system goes beyond certification. Quality outputs are determined by the inputs. Continual improvement requires leadership involvement, employee empowerment, periodic internal audits and management reviews, an effective corrective action and risk analysis program, and ongoing trending and analysis of data and key metrics. If your system is set up with the goal of continual improvement (rather than just to get through the certification audit) then you will reap the full benefits that your quality management system has to offer.