Design and Development – the ISO 9001 Standard requirements
Design and development should be carried out according to a disciplined method to prevent or minimize the occurrence of quality problems. Hence, the organization should ensure that products or services are developed in compliance with the customer specifications and requirements and in accordance with design and development planning or quality planning.
Managing and controlling the design and development activities in the organization defines the quality tasks necessary for design and development. Those activities shall cover the transfer of customer specifications and requirements into a designated process plan, translation of those requirements and specifications into technical details, and producing outputs necessary for the realization of the product.
Objectives of managing and monitoring the design and development under the QMS include the following:
- Identifying the necessary design and development tasks and setting the design and development activities as stages
- Ensuring delivery of a product or service according to the defined specification
- Defining the required inputs for the design and development activities
- Eliminating potential quality problems as much as possible
- Ensuring that the design and development progress according to regulatory and customer requirements
- Managing changes in design and development
8.3.1 General
The organization is required to plan and develop its design and development activities as a process. The goal of this process is to ensure that the realization of the product or service will be according to their specifications. As we know each process under the QMS has distinct properties:
- The different process stages, their sequences and interactions, as well as the activities and operations for design and development shall be planned.
- Inputs for design and development will be defined and planned.
- Responsibilities and authorities will be defined and delegated.
- Specification of the product or the service as the customer expects—the requirements will be delivered to design and development activities clear and complete and will answer the expectations of the interested parties in the organization.
- Design and development output shall take into account the resources in the organization that support the realization processes: Personnel, Infrastructures, Processes environments, Monitoring and measuring resources, Knowledge, External providers
- Support activities—design and development activities shall be planned in accordance with the support operations in the organization for: Competence, Awareness, Communication, Documented information
- The controls of the process stages shall be defined: Verifications, Validations, Appropriate criteria,
- Changes of the elements relevant to design and development will be managed.
8.3.2 Design and Development Planning
Process stages describing the design and the development process must be defined and determined. Process stages represent the main steps that the organization must follow and complete while designing and developing. They are the basis for the method to manage design and development. Defining and mapping the process stages
- Is an important stage necessary to evaluate whether design and development has achieved its objectives
- Creates a clear picture of design and development progress
- Allows authorities in design and development to release the outputs to the next stage
- Assists in prioritizing the activities of design and development
Verification Activities
Verification of design and development activities refers to the examination whether the development activities are advancing as planned. While planning the design and development process stages, the organization shall describe how one will examine whether design and development is advancing according to plan and when the verification activities will occur during the design and development process stages. In practice you must verify the progress of the development process by controlling it through attributes such as availability of inputs, transfer to development phases, performing activities, responsibility, time frame, risks, and acceptance of required outputs. The application of the verifications will be discussed in detail in clause 8.3.4—Design and development controls.
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This webpage contains only a fragment of the chapter 8 – Operation from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
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