Within the standard structure of ISO 9001 Quality Management System, the seventh title is determined as service realization. The third article of this chapter is titled geliştirme Design and Development ve and covers the following topics:
- Planning of design and development
- Design and development inputs
- Design and development outputs
- Design and development review
- Verification of design and development
- Validation of design and development
- Control of design and review changes
Design and development activities can often be long-lasting projects that fall within the working areas of different units. In this long process, naturally different needs may arise over time or conditions may change. In such cases, it may be necessary to make some changes on the project.
ISO 9001. If any changes are made to the project at any time according to project design and development form. The date of the change, the subject of the change, the name of the person requesting the change and the signatures of the authorized persons must be on the form.
The project leader must send a copy of the project design and development form to the quality management representative, in which the change is recorded.
If the change request comes from the customer, the evaluation and decision process is initiated. In the meantime, if the change directly affects the customer, the situation is communicated to the sales and marketing unit within the company. At this point, the relevant unit must obtain the written opinion of the customer.
Requests for changes that affect product performance, or changes that affect approved specifications received from the customer, are likely to directly affect the customer. In the meantime, the reason for the requested change and how it will be made must be recorded in the design and development form. If necessary, opinions and suggestions of other units should be obtained.
The project leader evaluates all the information and decides whether or not the change will be made, how and in which way the change will be made, when and at what stage of the change.
If you want to get more information about the control changes in design and development activities, please contact our company. TÜRCERT Technical Control and Certification You can get information from the experienced managers and employees of the company.