ISO 9001 Clause 8.3.2, "Design and development planning," provides guidelines for planning the design and development process to meet specific requirements. The organization is required to plan and document the design and development process. This planning is essential to ensure that the resulting products or services meet customer requirements and comply with relevant standards and regulations.
Key Clause 8.3.2 Elements:
Objectives and Requirements: The plan should define the objectives of design and development, taking into account the requirements of the product or service, including any regulatory or statutory requirements.
Resources: It should outline the necessary resources, including personnel, tools, equipment, and technologies, ensuring that everything required for successful design and development is available.
Controls: The plan should establish controls to monitor and measure progress during the design and development phases. This could involve checkpoints, milestones, and performance indicators.
Review and Verification: Procedures for reviewing, verifying, and validating the design should be outlined. This includes checking that the design meets specified requirements and is feasible for production.
Changes and Revisions: Processes for managing changes and revisions during design and development should be addressed. This ensures that modifications are documented, reviewed, and approved.
Communication: Effective communication channels among different stakeholders involved in design and development should be established. This ensures that everyone is informed about their roles, responsibilities, and the progress of the project.
Clause 8.3.2 Example
Consider a company developing a new software application. In adhering to ISO 9001 Clause 8.3.2, the company creates a comprehensive design and development plan. This plan outlines specific development stages, identifies key milestones, designates responsible team members, and establishes procedures for quality checks and client feedback.
It also includes provisions for addressing any unexpected issues that may arise during the development process. The plan is regularly reviewed and updated as needed to ensure its continued relevance and effectiveness.
Considerations for Clause 8.3.2 Design and Development Planning
Nature, Duration, and Complexity: The organization should evaluate the nature of the project, how long it will take, and its complexity. This understanding is crucial for developing an appropriate plan tailored to the specific characteristics of the design and development activities.
Process Stages and Reviews: Determine the required stages for the design and development process. This includes identifying applicable reviews to ensure that each stage meets the specified requirements.
Verification and Validation Activities: Establish activities for verifying and validating the design and development. This involves checking that the design meets specified requirements (verification) and confirming that the final product or service meets the intended use (validation).
Responsibilities and Authorities: Clearly define the responsibilities and authorities of individuals involved in the design and development process. This ensures that everyone understands their roles and has the necessary authority to carry out their tasks.
Resource Needs: Identify the internal and external resources required for the design and development process. This includes personnel, tools, equipment, technologies, and any external support.
Control of Interfaces: Consider the need to control interfaces between individuals or departments involved in the design and development process. This ensures seamless collaboration and communication.
Involvement of Customers and Users: Determine whether customers and users need to be involved in the design and development process. Their input can be valuable for meeting specific requirements and expectations.
Requirements for Subsequent Provision: Address the requirements for providing the final products or services. This involves planning for the transition from design and development to actual production or service delivery.
Customer and Interested Party Expectations: Recognize the level of control expected by customers and other relevant interested parties for the design and development process.
Documented Information: Identify the documented information needed to demonstrate that design and development requirements have been met. This includes records of reviews, verifications, validations, and other relevant information.
In summary, ISO 9001 Clause 8.3.2 emphasizes the importance of thoughtful planning, considering various aspects of the design and development process to ensure it is effective, controlled, and capable of meeting requirements.