The reason for implementing a Quality Management System (QMS) is to improve the consistency of your product, but ISO 9001:2015 itself does not specify the process you need to use for manufacturing a complex product. This is due to the fact that the ISO 9001 standard is intended to be non-prescriptive, which means that it does not detail how to meet the requirements, so that it can be applied to many different products and services. Here is an explanation of how you would apply clause 8.5, production and service provision, and clause 8.6, release of products and services, to a complex product.
Manufacturing a complex product
Complex products will very often require the use all of the requirements within these two sections, while simpler products or services will not. Here is a generic flow for manufacturing a complex product, how the ISO 9001 requirements relate to the process, and some examples of what a company might use in the process of manufacturing a complex product:
1) Define and create the required documentation. A complex product will need some documentation that gives the details on how to manufacture and verify it (clause 8.5.1 a). This may include detailed drawings, parts lists, assembly instructions, inspection instructions, and testing procedures. These documents will provide all of the information that is needed to assemble, adjust if needed, and verify that the product meets all of the requirements that have been identified as necessary for its function.
2) Package your documentation for your employees. Often called a product package, build documentation package, travel kit, or production order, you need a way to identify in one place all of the documentation needed for the assembly, adjustment, and verification. This can take many forms, from entirely hard copy paper packages to entirely electronically stored and accessed, but it will be the one place that you can go to know the requirements, and status of all the requirements, on the product– especially when changes are made (clause 8.5.6).
3) Identify and include additional information in the product package. If you have requirements for identification and traceability (clause 8.5.2), such as batches or serial numbers assigned to the product, then this is the stage when these are often assigned as part of issuing the build documentation package. The package should also define any special requirements to maintain the preservation of the product through the assembly, adjustment, and test phases, so that it is delivered in working condition (clause 8.5.4).
4) Assemble the product. Complex products will require different skills to assemble the product, such as soldering, welding, bonding, and complex assembly. These operations may need specific environments to be done properly (clause 8.5.1 d), and may also require special competencies such as certified soldering personnel (clause 8.5.1 e). Some of these processes may even be of a nature that they cannot be verified after the fact (such as soldering), and are reliant on controlling the process and potentially destroying a sample product for inspection to prove the process is still working properly (clause 8.5.1 f), rather than inspecting the product directly. On some occasions customers will supply components to be assembled into the product, and this needs to be controlled (clause 8.5.3).
5) Adjust the product. Sometimes a complex product will not work immediately, and will need a tuning or tweaking step before it can be ready to test. This may also need specially competent persons (clause 8.5.1 e), specific environmental conditions (clause 8.5.1 e), and appropriate measurement devices (clause 8.5.1 b) to get the job done.
6) Verify the product. After the product is fully functional, then an appropriate test regimen will take place to make sure that all of the requirements that the product needs to meet are indeed within the specification limits. This will be done per a test procedure that outlines the activities to take place and the criteria to be met (clause 8.5.1 c), as well as the equipment to use (clause 8.5.1 b). This will sometimes include testing property that is supplied by the customer for some tests (clause 8.5.3).
7) Release the product to the customer. After you have made sure that all of the planned requirements for the product have been met, or any deviations are accepted by the customer, then you can present the product to the customer with the evidence that this has happened (clause 8.6). On a complex product this may entail test reports, inspection reports, audit reports, or customer inspection audits and reports delivered as evidence that requirements are met.
8) Perform post-delivery activities. Often, complex products require activities after you deliver such as installation of the product or ongoing service and maintenance of the product (clause 8.5.5). This may be due to the needs of the product, legal requirements, or customer requirements, but it is an integral part of the product. This is not intended to deal with non-conforming products returned because they don’t work
Not all products and services are the same
While this gives an outline of the process for a complex product, it is important to remember that not all products and services are the same, which is why the requirements of ISO 9001 are written as they are, so that they can be used by any organization in any industry throughout the world. As the internationally recognized standard requirements for implementing a QMS, the ISO 9001 requirements will help you to make sure your QMS includes all the elements necessary for a well-functioning management system to control the quality of your products and improve both your processes and your customer satisfaction, which is what you want out of a good QMS.
Source: Mark Hammar