ISO 9001 New Product Design and Development Procedure

Benefits of Implementing ISO 9001:2015

Most regulatory bodies use the ISO standards as their framework for developing the regulations relevant to their industries. Therefore, businesses that align their processes to the ISO standards have a higher chance of compliance. In addition, some of the other benefits include:

• Improved Customer Trust: Implementing a quality management system aligned with ISO demonstrates the robustness of the quality control processes, improving customer confidence and delight.
• Efficient Processes: ISO recommends a risk-based approach to quality management, which leads to continuous improvement. This leads to removing inefficiencies from the systems, reducing waste, streamlining operations, and enabling data-driven decision-making. This results in cost-effectiveness and improved outcomes.
• Resource Optimization: With process efficiency comes optimization of resource utilization that lowers costs, reduces wastages, and increases profitability, competitive advantage, and innovation.
• Complaint Resolution: ISO 9001 guidelines help improve customer complaint handling efficiency through timely and improved problem-solving capabilities.

ISO Guidance for Product Design and Development

Clause 8.3 of ISO 9001:2015 provides guidelines for the Design and Development of Products and Services, focusing on meeting customer needs and conforming to specified standards.

The guidelines provide a step-by-step approach to design and development, including:

Step 1-Planning

Establish a systematic approach for the design and development processes, including:

• Defining objectives
• Allocating resources
• Assigning responsibilities
• Creating timelines

Step 2-Inputs

Determine and record the inputs needed for the design and development processes. This should be based on:

• Customer requirements
• Regulatory requirements
• Previous designs of similar products
• Feedback

Step 3-Control of Changes

The design and development of a product is an iterative process, with changes being introduced at various stages of the product life cycle. These need to be managed through:

• Evaluation
• Documentation
• Control
• Communication with relevant stakeholders

Step 4-Outputs

The outputs of the design and development processes must conform with the input requirements. Verify that the designs meet the specifications and are ready for production and marketing.

Step 5-Reviews

Systematic reviews must be conducted at every stage of the design and development process to monitor progress and ensure conformity to specifications. In case of any issues or changes, investigate further and take appropriate action.

Step 6-Verification

Verification is crucial to determining whether the outputs conform with the input specifications.

Step 7-Validation

The next step is the validation of outputs to ensure that they satisfy the intended goals and objectives and that the final product is fit for its intended purpose.

Maintaining Compliance with ISO

To ensure the processes are aligned with ISO and implemented as planned, businesses must do the following:

Document: Detailed documentation of all design and development processes must be maintained. These include:

• Specifications
• Reviews
• Verifications
• Validations
• Changes

Training: All stakeholders must be provided training to develop the skills needed to implement the processes and discharge their duties effectively.

Continuous Improvement: Periodic reviews, tracking, and monitoring of the design and development processes will help ensure it proceed as planned. Data, feedback, and performance metrics can identify areas that need improvement, and the necessary changes must be implemented.

Compliance: Periodical audits are necessary to ensure compliance with ISO 9001 requirements and internal standards.

A cloud-based product lifecycle management software such as ComplianceQuest’s ProductQuest can help with ISO compliance in new product development. It helps integrate multiple systems, such as ERP, CAD/CAM, CRM, etc., to provide a holistic view of data across all the systems and improve decision-making quality. This helps with:

• Visibility and Transparency: Siloed data systems limit the effectiveness of quality management processes. PLM systems improve visibility by providing a holistic view, ensuring insightful decisions that enhance product quality and performance.
• Documentation: The system enables the automation of document lifecycle management, from creation to obsolescence, improving compliance. A centralized repository facilitates version control, faster reviews, and approvals.
• Training: The solution also has a training feature that helps identify skill gaps and enables learning management through focused training to fill these gaps.
• Communication and Collaboration: In product development, this is key as multiple stakeholders come together for the design and development process. They can be alerted every time a change is made and reviewed and approved it for faster decision-making.
• Change Management: Every time a change is made, the risk assessment, reviews, and approvals can be managed on the platform for greater efficiency and effectiveness. Teams downstream and upstream are also alerted when a change is approved to make appropriate changes to their process, where required.
• Risk Management: ISO requires a risk-based approach. The risk management feature helps identify, rank, and implement controls to mitigate risks.

The greatest advantage of the CQ PLM is the integration with the quality management system, thereby ensuring quality at every stage of the design and development process.

To know more, visit www.compliancequest.com.