ISO 9001:2015 Clause 8.3

What is ISO 9001:2015 Clause 8.3?

Clause 8.3 of ISO 9001:2015 addresses the Design and Development of Products and Services. This clause specifically focuses on the processes involved in designing and developing products or services to ensure they meet customer requirements and conform to specified standards.

Key points outlined in Clause 8.3 include:

Design and Development Planning:

Organizations are required to establish a systematic approach to planning the design and development processes. This includes defining objectives, allocating resources, establishing responsibilities, and creating schedules.

Inputs to Design and Development:

Identify and document the inputs necessary for the design and development processes, which can include customer requirements, regulatory requirements, previous similar designs, and lessons learned.

Control of Design and Development Changes:

Implement procedures to manage changes during the design and development phases. Changes should be evaluated, documented, controlled, and communicated to relevant parties to ensure they do not adversely affect the product or service.

Design and Development Outputs:

Ensure that the outputs of the design and development processes meet the input requirements. This involves verifying that designs fulfill specified requirements and are suitable for subsequent production, delivery, or provision of services.

Design and Development Reviews:

Conduct systematic reviews at planned stages of the design and development process to evaluate progress, and conformity to requirements, and to identify any issues or necessary changes.

Design and Development Verification:

Verify that the design and development outputs meet the input requirements. This involves confirming that the design and development have been carried out as planned and that they fulfill specified requirements.

Design and Development Validation:

Validate the design and development outputs to ensure that they meet the intended needs and objectives. This step ensures that the final product or service is fit for its intended use or purpose.

Control of Design and Development Changes:

Manage and control any changes made during the design and development phase to prevent adverse impacts on product or service conformity.

Compliance with Clause 8.3 involves establishing and maintaining robust processes for designing and developing products or services, ensuring that these processes are controlled, documented, and regularly reviewed to meet customer needs and comply with relevant standards or regulations.

How do you comply with Clause 8.3?

Compliance with Clause 8.3 of ISO 9001:2015, which deals with the Design and Development of Products and Services, involves a systematic approach to managing these processes.

Here are steps to ensure compliance with Clause 8.3:

Establish Design and Development Processes:

Develop documented procedures and guidelines for the design and development of products or services. This includes planning, resource allocation, and defining responsibilities.

Understand and Document Requirements:

Thoroughly understand customer needs and expectations, regulatory requirements, and any other pertinent inputs. Document these requirements clearly and comprehensively.

Design Planning:

Develop a detailed plan for the design and development process. This plan should outline objectives, timelines, resources required, and any specific milestones.

Control Design Changes:

Implement a robust change control process to manage any modifications during the design and development phases. Ensure that changes are documented, assessed for impacts, and approved before implementation.

Design Reviews:

Conduct systematic reviews at predetermined stages of the design and development process. These reviews should assess progress, and compliance with requirements, and identify any issues that need attention.

Verification and Validation:

Perform verification to ensure that design outputs meet input requirements and conduct validation to confirm that the final product or service meets the intended needs and objectives.

Document and Record:

Maintain detailed documentation of all design and development activities, including specifications, reviews, verifications, validations, and changes made.

Training and Competence:

Ensure that personnel involved in the design and development processes have the necessary skills, training, and competence to perform their roles effectively.

Continuous Improvement:

Regularly monitor and analyze the design and development processes. Use feedback, data, and performance metrics to identify areas for improvement and implement necessary changes.

Compliance Verification:

Periodically audit the design and development processes to verify compliance with ISO 9001 requirements and organizational standards.

Complying with Clause 8.3 requires a methodical and structured approach to managing design and development activities. It involves careful planning, thorough documentation, systematic reviews, and a commitment to continual improvement to ensure that products or services meet customer requirements and conform to established standards.

Other ISO 9001:2015 Clauses:

What is the History of Clause 8.3?

Clause 8.3 in ISO 9001:2015, focusing on the Design and Development of Products and Services, has evolved significantly over the different iterations of the ISO 9000 series standards.

The history of Clause 8.3 can be traced through the various versions of ISO 9001:

ISO 9001:1994:

In this version, the concept of design and development was included but was relatively basic compared to later versions. It highlighted the need for organizations to plan and control the design process but was less prescriptive about specific steps or processes to follow.

ISO 9001:2000:

This version saw a significant shift in how design and development were addressed. The standard emphasized a more structured approach, requiring organizations to establish documented procedures for design and development, focusing on planning, inputs, outputs, reviews, verification, and validation.

ISO 9001:2008:

Minor revisions were made to improve clarity and alignment with other management system standards. The emphasis on a systematic approach to design and development continued, with more emphasis on risk management and control of design changes.

ISO 9001:2015:

This edition brought a substantial change in the structure and content of the standard, adopting the High-Level Structure (HLS) to align with other management system standards. Clause 8.3 in this version emphasizes a more holistic approach to managing design and development processes, focusing on planning, inputs, controls, reviews, verification, validation, and managing changes.

The evolution of Clause 8.3 reflects a progression from a basic acknowledgment of the importance of design and development to a more comprehensive and structured approach. Over time, the standard has become more detailed and prescriptive, guiding organizations to establish robust processes for designing, developing, verifying, and validating products and services to ensure they meet customer requirements and conform to specified standards.

The changes across the different versions emphasize the importance of a systematic and controlled approach to managing the design and development processes within organizations to enhance product and service quality, and meet customer needs effectively.

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