How is a process map created

Building blocks for quality management according to ISO 9001Create process maps

In section 8 of ISO 9001 some essential processes for quality management are named and the requirements for them are explained in the subsections. A higher-level process map can first be created for these processes. The individual areas can be supplemented by more detailed process maps that depict and describe sub-processes, sub-processes or individual process steps. The important processes and requirements are named below.

Identify customer requirements and verify compliance

The company must explain how it determines and evaluates the needs and requirements of customers for its products and services. This can take the form of customer surveys, market analyzes or market observations (trend research). Processes must be defined with which customer requirements are checked and evaluated for feasibility.

The company must ensure that legal and regulatory requirements are met. For this, there must be processes that identify and document these requirements and transfer them to the company's processes and methods.

In addition, the company must define processes to determine customer opinions and customer satisfaction. This can be done through customer surveys or evaluating complaints and service requests.

Development of products and services

The process of developing products and services is dealt with in detail in ISO 9001. Essential features of the development process are that the company must involve the customers and that it must ensure that legal and regulatory requirements are complied with and implemented in the product.

During the development of products and services, the company must check whether the product meets the previously defined requirements (verification) and whether it can therefore also be used and needed by the customer (validation). Test processes must be determined for this examination and evaluation.

The development process concludes with the fact that all information and documents are available with which a pre-series production (sample) and then the series production can be carried out.

Control of products and services from suppliers and external partners

All products and services that are procured from suppliers or other external partners must be checked. To do this, processes for the incoming goods inspection must be determined. It also defines how the cooperation with the suppliers works and what is done in the event of defects or complaints.

Manufacture, manufacture, manufacture and assemble products and provide services

The manufacture of products and the provision of services are the core processes of a company. The company must first ensure that all information is available so that the manufacture of the products and the provision of the services can proceed in accordance with the requirements.

In addition, the framework conditions such as infrastructure and process conditions must be suitable and beneficial. This applies to noise, temperature, cleanliness, ergonomics and occupational safety, for example.

It is crucial that monitoring and measurement activities are carried out during the manufacturing process in order to verify that the criteria for controlling processes and process results as well as the acceptance criteria for products and services are met. This requires resources such as measuring devices and competent employees.

Control of non-conforming process results, products and services (post-processing)

During the manufacturing process, it must be ensured that no defective products are delivered to customers. Therefore, such products or services must be identified and labeled. Processes that do not deliver the expected results must also be “flagged”.

In order to remedy such defects or errors, processes for post-processing or sorting can be determined. If necessary, customers must be informed that products cannot be delivered. In individual cases, products can also be delivered that do not meet the requirements; a special approval is required for this.

After sales service and product monitoring in the market

After a product has been placed on the market, the company must examine how it is used by customers. For this purpose, processes for product monitoring in the market, for handling customer complaints and for checking the legal requirements must be determined.

For special products, measures for servicing, maintenance, repairs or return and disposal as well as further after-sales services can be provided as service offers for customers. Processes are also established for this.

Documentation of quality management and changes

All processes must be regularly monitored, checked and documented. These documents must be created, forwarded and archived. Among other things, this is intended to ensure traceability in accordance with Section 8.5.2 of ISO 9001 if defects occur later during use. All further requirements for documentation are explained in section 7.5. Corresponding documentation processes must be determined so that these requirements are met. This also applies to all changes or improvements that are made to the processes as part of quality management.