Strahinja Stojanovic The prospect of implementing a Quality Management System (QMS) and certifying it according to IATF 16949:2016 can seem overwhelming. If you aren’t sure where to start, read on for a helpful overview of the 12 steps you need to take for a successful implementation. Following these steps will help you ensure that you don’t miss anything, and get you prepared for your certification audit.
1) Get support from management. First and foremost, you need to work on your sales pitch to top management, to show them how important IATF 16949 is to your business. Without their support, your implementation is doomed to failure.
2) Identify QMS requirements. Just as importantly, you need to identify each of the requirements that must be addressed in your Quality Management System. Obviously this includes the standard’s requirements, but also laws and regulations, and requirements for your company’s culture.
3) Define the scope. The scope of your QMS refers to its boundaries; that is, which locations, which processes, which departments are to be included in your QMS. The scope can be the whole company, but often this is not necessary, as you don’t want to include any areas of your organization that don’t influence your quality management.
4) Define your processes and procedures. You’ll need to define any procedures that are mandatory according to IATF 16949:2016, as well as any extra processes and/or procedures that your company has deemed necessary to provide the required consistency and quality. The important thing is to define all of your business processes, and observe their interactions in your organization – this is where problems tend to show up. For more information about mandatory documents, see: List of mandatory documents required by IATF 16949:2016.
5) Implement these processes and procedures. Now you need to put all of these processes and procedures into service. Most likely, some of these are already implemented; they just need to be tweaked to comply with the new standard. The others will need to be developed from scratch.
6) Provide access to training and awareness programs. A Quality Management System is only as effective as the employees who work within it. If they have no knowledge of your QMS, or how they fit into the system, they can’t be expected to follow the new processes. Make sure you provide training on IATF 16949, its benefits to the company and to employees, and any changes to employees’ processes.
7) Choose the right certification body. This can be nearly as important as all the work you have to put in leading up to your certification audit. The certification body is responsible for coming into your company to audit your Quality Management System, and determine whether or not it’s compliant with the requirements of the IATF 16949:2016 standard, and whether it is effective and showing improvement. You’ll want to talk to several certification bodies, and review their references, before making a decision.
8) Operate the QMS and collect records. You have your new and updated processes implemented, so now you need to spend some time operating the QMS so that you can collect records. These records will be required in the certification audit to prove that your processes are effective, meet the requirements laid out for them, and are being improved as needed. The certification body will tell you how long you need to do this before they will consider your QMS to be mature enough to determine if it’s compliant with the standard.
9) Perform the internal audit. But, before the certification body arrives, you will first need to audit your processes internally. This is your opportunity to verify that each process is doing what it should, and if any problems are found, to use your corrective action process to fix them.
10) Conduct the management review. It’s not enough for your management to show support during IATF 16949 implementation – they also must show involvement in the ongoing maintenance of the Quality Management System. It is the job of management to review the required data and results from the QMS activities to confirm that each process has the resources it needs to be effective, and to show improvement.
11) Take corrective action. If any problems are found during your records collection, internal audit, or management review, you must investigate the root cause and take action to correct it. This is your primary method of ensuring continuous improvement – a key attribute of an IATF 16949-certified QMS.
12) Certification audits. Upon completion of the previous 11 steps, when you feel you’re ready, the certification body will come into your organization to perform the certification audit. This will first involve comparing the plans, processes, and procedures of your Quality Management System to the requirements of the standard. If any gaps are found and reported by the auditor, you will need to address them and show evidence of their correction. Next, when you have operated your system for the required amount of time, the auditors will return for the main audit, when they will compare the records you have collected to your plans, as well as to the standard’s requirements. They will look to see if you took care of any nonconformances found while operating your QMS, during internal audits, or in the management review. In a week or so, the audit team will provide a report stating their findings and listing any necessary corrective actions. Once these are addressed, and the auditors are satisfied that your QMS fulfills the requirements, they will recommend certification.
Create a plan to meet your objectives
Be sure to take the necessary time to develop a sound plan for your QMS implementation, so you can guarantee you have the resources you need in the beginning. A good plan will ensure that your implementation project goes well, and help you to avoid wasting time and resources.
Use this Project Checklist for IATF 16949:2016 Implementation to easily keep track of all the steps of your IATF 16949 implementation project.
