Mark Hammar Creating an aerospace Quality Management System (QMS) using the requirements of AS9100 Rev D can be a complex task, and many people have trouble deciding where to start. Here are the steps that you need to take to make your implementation run smoothly:
1) Get management support: This may not seem like it is very important, but the truth of the matter is if you do not have management support for implementing your QMS, it will be very difficult to implement, if not ending in ultimate failure. Top management has many roles to play in the QMS, and if they are not on board you will have difficulty.
2) Establish your project: While this is not strictly a mandatory step, it is very helpful to think of your QMS implementation as a project with a budget, assigned resources, and an implementation project plan. By doing this, you can more easily track the tasks necessary to make your implementation run smoothly and identify problems before they become critical.
3) Identify organizational context and interested parties: One newly added critical step in the AS9100 requirements is the identification of the circumstances that form the setting of the organization (organizational context), which include the internal and external issues that affect the organization, as well as identifying who the interested parties of your QMS are and how their needs apply to you. You can find out more in this article: AS9100: Understanding the requirements of context of the organization.
4) QMS scope and management aspects: From your definition of context and interested parties, you will be able to identify the scope of your QMS – the overall goal that your QMS is intended to meet and people can then aspire to. This is then clarified in quality objectives and other documented information that will ensure that the goals of management are communicated and understood.
5) QMS processes and procedures: There are many processes and procedures defined in the AS9100 Rev D requirements that are necessary for a functioning QMS, and this is when you should identify these processes, their interactions, what documentation you need to ensure that the intent of each process is met, and what records you will need to be able to demonstrate that the process was done properly.
6) Implement your processes, procedures, and associated controls: Once you have defined the processes, procedures, and controls, you can then roll these out to your organization so that people can start working according to the new or updated procedural information.
7) Train employees and make them aware: Of course, having your plans for each process in a document is not enough; people need to be trained to the processes and made aware of how their activities affect the QMS. Everyone needs to be brought on board your QMS. Training records will help to show that this not only took place, but also that all employees were involved.
8) Find the right certification body: The certification body is the company that will come to your organization and audit your QMS against the AS9100 Rev D requirements so that they can issue you a certification saying you comply – and there a lot of them out there. Finding the right certification body that has auditors who are knowledgeable in your industry and type of product is important to ensure that you get the most out of these audits.
9) Use your QMS processes: Because the certification body will be comparing the planned activities of your processes against what is actually happening in your processes, they will need you to use your processes for a period of time so that you can accumulate the records needed to demonstrate this. Personnel may even find improvement during this time.
10) Internal audits: One of the main ways for you to know that your processes are happening as planned is to do audits internally within your company. You will need to perform an internal audit of every one of your identified QMS processes before the certification body auditors come, so make a plan for this to happen. Any problems that are found will need to have corrective action taken to remove the root cause and ensure that the problem does not occur again.
11) Management review: It is critical that your top management is involved in the review of your QMS to assess that it is properly implemented, effective, efficient, and improving. The reason that management needs to be involved is so that they can adequately assign the resources needed for your QMS to meet the needs of your customers and improve customer satisfaction.
12) Documentation review by your certification body: During this stage 1 certification audit, your certification body will send auditor(s) to assess your QMS documentation against the requirements of AS9100 Rev D to ensure that there is nothing missing, and that what is there meets the intent of those requirements. They will issue a report and any nonconformance found will need to have corrective action taken as above.
13) Main audit by your certification body: This is what many people consider to be the main audit for certification: the stage 2 certification audit. Here your certification body will send auditor(s) to assess every process and procedure in your QMS to determine whether the evidence accumulated during the functioning of your processes demonstrates that the processes meet the intended outcomes. Once again, the auditor(s) will issue a report and corrective action must be taken for any nonconformance identified.
On to QMS maintenance and improvement
Once the certification body auditor(s) are satisfied that your QMS is in place and functioning, they will recommend that your company be certified as having a QMS that meets the requirements of AS9100. Then, you can not only display your certification and advertise to your customers that you are certified according to AS9100 Rev D, but you can also start the work on improving your QMS to find your return on investment and improve your customer satisfaction – because improvement is one important reason to have a QMS.
Want to see a graphical representation of the AS9100 Rev D implementation process? Download the Diagram of AS9100 Rev D Implementation Process.
