An internationally recognized standard for developing, implementing, and maintaining a quality management system for a business is ISO 9001:2015. It can be used by any business and is intended for usage by organizations of any size and in any sector. Due to the fact that it is an accepted international standard and serves as the foundation for any business to develop a system to guarantee customer satisfaction and improvement, many businesses demand the ISO 9001 QMS certification from their suppliers. Customers will feel more secure knowing that you have a Quality Management System in place that is based on the seven ISO 9001 quality management principles when you are certified to ISO 9001.
The Quality Management System (QMS) is made up of numerous different steps that must be correctly integrated in order for them to work. Making sure that each process is carried out according to plan is essential to ensuring that operations further down the line may accomplish their goals since the product of one process frequently becomes the input of another. In ISO 9001:2015, clause 4.4.1 summarises the process approach, and clause 4.4.2 explains it further by stating that you must “retain documented information to have confidence that the processes are being carried out as planned.” Here are a few examples of how to show that the QMS process is being followed correctly.
Key performance indicators: An overview of the efficiency of the process
Monitoring a performance indicator, which is selected for that process to be able to inform you that the process is correctly running, will allow you to determine at the highest level whether a process is carried out as planned. For instance, your purchasing procedure is set up so that you fill out your purchase orders completely and decide which supplier to acquire from, ensuring that the goods and services you get from suppliers are perfect the moment you receive them. Thus, a key performance indicator (KPI) for the purchasing process may be the number of goods or services your supplier supplies to you that totally match your needs. You can get a good sense of how well your purchasing process is working overall by monitoring the percentage of conforming deliveries. This will help you determine whether the process is proceeding according to plan. Your process is documented in your KPI, which is information.
Internal audits: A thorough examination of process effectiveness
The internal audit examines the effects of processes in greater depth. As stated in ISO 9001:2015 clause 9.2, the declared objective of the internal audit program is to guarantee that the QMS complies with the specifications or to verify that the processes follow the planned arrangement. When implementing an internal audit program using the process approach, you start with the requirements for a process (the planned arrangements), gather audit proof that the process outputs satisfy the requirements, and then pinpoint any areas where corrections are required because the outputs are not conforming.
For instance, in the previous example of purchasing, you would develop an audit checklist using any purchasing procedures (recorded knowledge on the process), giving you the intended audit arrangements. The next step would be to compare the records from the purchasing process—documented information on the outcomes of the process with the anticipated arrangements. These records might include purchase orders, supplier approvals, and records of goods and service receipts. The goal of auditing for conformity is to ensure that the records show that the procedure was carried out according to plan.
The key point is that company must consider what records it will maintain while creating its processes. As you create the process stages, ask yourself, “What ISO 9001 documents record organization need to keep at this stage to demonstrate that it was done correctly so that product conformity is maintained?” Keep this in mind when you create your procedures, and make sure that you can demonstrate that everything went according to plan.
Records: Evidence that a process was carried out as intended
To put it simply, you must be able to demonstrate through your records that your process was followed exactly as intended in order to achieve product and service conformance. Designing your records to readily demonstrate this is crucial because if a procedure affects the conformance of your good or service, you must be able to demonstrate that you carried out the process as you had intended.
Not only will you have to demonstrate this to the auditors of your certifying body, but also to your clients, possibly a government agency depending on the circumstances, and finally to you. If there is any doubt that the product or service compliance is accurate, then you will want to have the proof ready to show unequivocally that your process was carried out as intended to satisfy the product and service standards.