ISO 9001 Clause 8.3 Design and development of products and services is a heading label. Clause 8.3.1 titled "General" emphasizes the necessity for an organization to create, execute, and sustain a design and development process suitable for ensuring the successful delivery of products and services.
Key Points to ISO 9001 Clause 8.3.1
Establishment of a Process: The organization must define a formal process for design and development that aligns with its specific needs and the nature of the products and services it offers. This process should be documented and communicated across the relevant departments.
Appropriateness: The process established for design and development should be appropriate to guarantee the quality, safety, and efficacy of the resulting products or services. This appropriateness may vary based on the complexity, nature, and criticality of the products or services offered.
Regularity and Consistency: The established design and development process should be consistently applied and continuously maintained to ensure the ongoing delivery of high-quality products or services.
Compliance: The process must comply with regulatory requirements, customer needs, and any other relevant standards or specifications applicable to the industry or market.
Example Clause 8.3.1
Suppose a company manufactures electronic devices, such as smartphones. Here's how ISO 9001 Clause 8.3.1 might be applied:
ABC Electronics is dedicated to ensuring a thorough and reliable design and development process for its smartphones.
Establishment of a Structured Process: ABC Electronics outlines a design and development process, beginning with initial concept creation, involving various departments such as design, engineering, manufacturing, quality control, and marketing.
Appropriate Design and Development Procedure: The process is adapted to the complexity and sensitivity of smartphone development. It includes various stages like concept ideation, prototyping, testing, and refinement before full-scale production.
Regular Review and Consistency: Regular internal audits and reviews of the design and development process are conducted to ensure consistency and continuous improvement. The process is subject to updates based on emerging technologies and customer feedback.
Compliance with Standards: The process is aligned with industry standards, ensuring compliance with safety regulations, performance standards, and customer requirements.
The company maintains detailed documentation at each stage of the design and development process, ensuring that it is effectively followed by employees involved in various aspects, including research, development, testing, and production.
This example showcases how the organization meets the requirements of ISO 9001 Clause 8.3.1 by establishing a comprehensive and appropriate process for the design and development of its products.
ISO 9001:2015 Clause 8.3.1 Design and Development of Products and Services
In essence, clause 8.3.1 underlines the need for organizations to develop and uphold a structured and suitable design and development process. This process should be in place to assure the successful production and delivery of high-quality products and services that meet the organization's, as well as the customer's, requirements and expectations.