ISO 9001:2015 Clause 8.3.5 Design and development outputs

ISO 9001:2015 Requirements

The organization shall ensure that design and development outputs:
a) meet the input requirements;
b) are adequate for the subsequent processes for the provision of products and services;
c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.
The organization shall retain documented information on design and development outputs.

1) Design and Development Outputs

Design and development outputs are the tangible results, deliverables, and documentation produced during the design and development process of a product, service, or process. These outputs are the culmination of the design and development activities and are used to guide the subsequent stages of production, implementation, and testing. Design and development outputs play a crucial role in ensuring that the final product or service meets the specified requirements and objectives.Design and development outputs can be in the form of drawings, a prototype of the finished product or a specification. These outputs shall meet the input requirement for design and development and should be appropriate for use in processes that follow. Design output may also include a reference to any monitoring and measuring related requirement and acceptance criteria, if applicable. The design and development outputs should ensure that the final products or services that are produced based on the design are fit for their intended use. A typical example of design and development output for an architecture company are drawings, specifications, material schedules, sample boards, etc. The specific nature of design and development outputs can vary widely depending on the industry, the complexity of the project, and the type of product or service being developed.

The design and development output is the result of design and development process. The output is a clear description of the product, containing detailed information for production. Ensure that your organization’s design and development outputs reconcile with its design and development inputs by:

1. Ensuring outputs meet input requirements e.g. checklists, design review records, authorization to proceed, customer acceptance, and product certification;
2. Ensuring outputs are adequate for product and service provision e.g. standards, specifications, schemes, drawings, models, part lists, materials, methods, manufacturing instructions, technical packages, tooling, machine programs, preservation, handling, packaging, specialist training, user instructions, service manuals, repair schemes, and external provision;
3. Reference to monitoring and measuring equipment e.g. inspection equipment, gages, instruments, environment;
4. Acceptance criteria e.g. product/service specification, limits, tolerances, and quality acceptance standards;
5. Product/service characteristics e.g. key characteristics, customer critical features, interface features, inspections, service intervals, and operating characteristics;
6. Critical items such as identification, key characteristics, special handling, service intervals, component lifing, cyclic life, life management plans, source and method change, and traceability;
7. Outputs are approved prior to release e.g. scope of authorization, authorized persons, levels of authorization, method of authorization and documented information is retained.

Outputs of the detailed design are the final technical documents used for purchasing, production, installation, inspection and testing, and servicing. Design output includes production specifications as well as descriptive materials which define and characterize the finished design and include drawings and documents used to procure components, fabricate, test, inspect, install, maintain, and service the product.However, some common examples of design and development outputs include:

1. Design Specifications: Detailed documents that describe the design requirements, features, and functionality of the product or service. These specifications serve as a blueprint for the development and manufacturing processes.
2. Engineering Drawings: Technical drawings that illustrate the physical dimensions, tolerances, and configurations of components or systems. These drawings are often used in manufacturing and construction.
3. Prototypes and Models: Physical or digital prototypes that represent the final product or service. Prototypes are often used for testing, validation, and user feedback.
4. Software Code: For software development projects, the code written by programmers is a critical design output. It defines the functionality and behavior of the software application.
5. Technical Documentation: Comprehensive documentation that provides detailed information on how to build, operate, and maintain the product or service. This may include user manuals, installation guides, and maintenance procedures.
6. Test Plans and Procedures: Documents outlining the testing strategies, methodologies, and procedures to verify and validate the product’s performance and functionality.
7. Validation Reports: Summaries of the results of validation activities, demonstrating that the product or service meets user needs and intended use.
8. Verification Records: Records of activities and test results demonstrating that the design outputs conform to design inputs and specified criteria.
9. Change Control Records: Documentation of any changes or revisions made to the design during the development process. This includes change requests, change orders, and updated design documentation.
10. Safety and Compliance Documentation: Documentation showing that the product or service complies with safety standards, regulatory requirements, and industry-specific regulations.
11. Bill of Materials (BOM): A list of all the materials, components, and parts required to build the product, including quantities and specifications.
12. Cost Estimates: Estimates of the production or development costs associated with the design, including materials, labor, and overhead.
13. Project Plans and Schedules: Documents outlining the project plan, including timelines, resource allocation, and milestones.
14. User Interface (UI) and User Experience (UX) Designs: For software and digital products, UI and UX design outputs define the visual and interactive aspects of the user interface.
15. Supplier and Vendor Specifications: Specifications provided to suppliers or vendors for the procurement of components or services needed for the product.

These design and development outputs serve as critical references and guidance for subsequent stages of manufacturing, implementation, and testing. They also provide a basis for verification and validation activities to ensure that the final product or service meets quality standards and customer requirements. Proper documentation and management of design and development outputs are essential for effective quality control and regulatory compliance.Specifications and procedures for product packaging and labelling are also part of the design and development output. Support documentation (e.g. calculations, risk analysis, test results, verification and validation reports, etc.) is also part of the design and development output. The transfer of a design to production typically involves review and approval of specifications and procedures and, where applicable, the proving of the adequacy of the specification, methods and procedures through process validation including the testing of finished product under actual or simulated use conditions. The design transfer phase ensures that the design is correctly translated into production specifications, such as assembly drawings, component procurement specifications, workmanship standards, manufacturing instructions, and inspection and test specifications. They may also be:

1. Documentation (in electronic format as well as paper);
2. Training materials (e.g. manufacturing processes, assembly, and test and inspection methods);
3. Digital data files (e.g. computer-aided manufacturing (CAM) programming files);
4. Manufacturing jigs and other aids (e.g. molds or templates).

The Engineering Manager should ensure that the design transfer process addresses the following basic elements by:

1. Undertaking a qualitative assessment of the completeness and adequacy of the production specifications;
2. Ensuring that all documents and articles that constitute the production specifications are reviewed and approved;
3. Ensuring that only approved specifications are used for manufacture and production.

Prior to execution of a work transfer, analysis of any regulatory or contractual requirements are reviewed and flowed down through the supply chain to ensure compliance of any established requirements.

2) The organization shall ensure that design and development outputs meet the input requirements

Ensuring that design and development outputs meet the input requirements is a fundamental principle in quality management and product development. This process is crucial to produce products, services, or processes that align with customer needs and expectations, as well as internal requirements and standards. Here’s how an organization can ensure that design and development outputs meet the input requirements:

1. Clearly Define Design Inputs: Start by thoroughly defining and documenting the design inputs. These inputs should encompass customer requirements, regulatory requirements, internal standards, and any other relevant criteria that the product or service must meet. Ensure that these inputs are specific, measurable, and unambiguous.
2. Traceability: Establish traceability between design inputs and design outputs. This means that you should be able to trace every aspect of the design back to a specific requirement or input. This ensures that nothing is overlooked or omitted.
3. Design Review: Conduct design reviews to evaluate the design against the input requirements. These reviews involve a cross-functional team that assesses the design documentation, specifications, and plans to confirm alignment with the defined inputs.
4. Verification Activities: Implement verification activities to confirm that the design outputs meet the input requirements. Verification involves activities such as inspections, tests, and analyses to ensure that the design conforms to specifications.
5. Validation Activities: Perform validation activities to confirm that the design outputs meet the user needs and intended use. Validation typically involves real-world testing and evaluation to ensure that the product or service functions as expected in its intended environment.
6. Documentation Control: Establish document control processes to manage design inputs and outputs effectively. Ensure that all design documentation, including changes and revisions, is documented and maintained according to established procedures.
7. Change Control: Implement a change control process to manage any changes made to the design. Ensure that changes are assessed for their impact on the input requirements and are properly documented, reviewed, and approved.
8. Feedback Mechanisms: Establish feedback mechanisms for continuous communication between different departments and teams involved in the design and development process. This promotes clarity and alignment with input requirements.
9. Risk Management: Incorporate risk management activities into the design and development process. Identify and assess potential risks that could impact the alignment of design outputs with input requirements and take proactive measures to mitigate these risks.
10. Customer and Stakeholder Involvement: Involve customers and relevant stakeholders in the design and development process to ensure their requirements and feedback are considered and integrated into the design.
11. Training and Competence: Ensure that personnel involved in the design and development process are adequately trained and competent to understand and address the input requirements effectively.
12. Validation by Independent Parties: In some cases, especially in highly regulated industries, it may be necessary to have independent third parties validate the design outputs to provide an unbiased assessment of compliance with input requirements.

By implementing these measures and maintaining a systematic approach to design and development, organizations can increase their confidence that the design outputs will indeed meet the input requirements. This, in turn, leads to higher-quality products, services, or processes that are more likely to meet customer expectations and regulatory compliance.

3) The organization shall ensure that design and development outputs are adequate for the subsequent processes for the provision of products and services

Ensuring that design and development outputs are adequate for subsequent processes is a critical aspect of the design and development phase within a Quality Management System (QMS). This requirement in ISO 9001:2015 emphasizes the importance of producing outputs that are not only compliant with input requirements but also suitable for the subsequent stages of product or service provision. Here’s how an organization can ensure that design and development outputs meet this requirement:

1. Clear Design Outputs: Start by ensuring that design outputs are clearly documented and well-defined. This includes design specifications, drawings, plans, and any other relevant documentation that provides a clear representation of the product or service.
2. Consideration of Subsequent Processes: During the design and development phase, consider the processes that will follow, such as manufacturing, testing, installation, or service delivery. Ensure that the design outputs are compatible with and supportive of these subsequent processes.
3. Interdisciplinary Collaboration: Promote collaboration between different teams and departments involved in the design and subsequent processes. Encourage communication to identify and address any potential issues or challenges in the transition from design to production or service provision.
4. Design for Manufacturability (DFM) and Design for Serviceability (DFS): Implement DFM and DFS principles where applicable. DFM focuses on designing products in a way that makes them easier and more cost-effective to manufacture, while DFS focuses on designing products for ease of servicing and maintenance.
5. Prototyping and Testing: Conduct prototyping and testing to validate that the design outputs are feasible and practical for subsequent processes. Address any issues or limitations identified during testing before proceeding further.
6. Risk Assessment: Perform a risk assessment to identify potential risks or barriers in transitioning from design to subsequent processes. Develop mitigation strategies to minimize these risks.
7. Supplier and Vendor Collaboration: If your organization relies on external suppliers or vendors, collaborate with them to ensure that design outputs align with their capabilities and requirements for production or service delivery.
8. Quality Control: Implement robust quality control measures throughout the design and development phase to ensure that design outputs meet not only technical specifications but also quality standards and reliability requirements.
9. Documentation and Change Control: Maintain clear documentation of design outputs and any changes made during subsequent processes. Implement a change control process to manage modifications effectively and ensure that they remain suitable for the subsequent stages.
10. Continuous Improvement: Continuously monitor and evaluate the effectiveness of design outputs in subsequent processes. Use feedback and lessons learned to drive improvements in future design and development projects.

By following these steps and considering the adequacy of design and development outputs in the context of subsequent processes, organizations can enhance the seamless transition from design to production or service provision. This ultimately contributes to the delivery of high-quality products or services that meet customer requirements and expectations while maintaining efficiency and effectiveness throughout the value chain.

4)The organization shall ensure that design and development outputs include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria

Ensuring that design and development outputs include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria is a crucial aspect of quality management within the design and development process. This requirement in ISO 9001:2015 emphasizes the need to establish clear criteria for evaluating the performance and conformity of the product, service, or process being developed. Here’s how an organization can fulfill this requirement effectively:

1. Define Monitoring and Measuring Requirements: Clearly define the monitoring and measuring requirements that are relevant to the product, service, or process being developed. These requirements should be based on the design inputs and specified criteria, including customer requirements, regulatory standards, and internal quality standards.
2. Establish Acceptance Criteria: Develop acceptance criteria that specify the conditions or standards that must be met for the product, service, or process to be considered acceptable. Acceptance criteria provide clear guidelines for determining whether the outputs meet the defined requirements.
3. Incorporate into Design Outputs: Ensure that the monitoring and measuring requirements and acceptance criteria are incorporated directly into the design outputs. This may include including them in design specifications, drawings, test plans, or other relevant documentation.
4. Traceability: Establish traceability between the monitoring and measuring requirements, acceptance criteria, and the design inputs. This traceability ensures that every design element and requirement is accounted for in the monitoring and measurement process.
5. Verification and Validation Planning: Develop verification and validation plans that outline the specific methods and activities to be used for assessing compliance with the monitoring and measuring requirements and acceptance criteria.
6. Testing and Inspection Procedures: Create detailed procedures for testing and inspection activities that align with the monitoring and measuring requirements and acceptance criteria. These procedures should specify how, when, and where measurements will be taken and how acceptance will be determined.
7. Measurement and Data Collection: Implement measurement and data collection processes that allow for the collection of relevant data to assess performance and conformity. Ensure that measurement equipment is calibrated and maintained as necessary.
8. Record-Keeping: Maintain comprehensive records of all monitoring and measurement activities, including the results obtained and any deviations from acceptance criteria. These records serve as evidence of compliance.
9. Data Analysis: Analyze the collected data to determine whether the outputs meet the established acceptance criteria. Identify any non-conformities or areas that require corrective actions.
10. Corrective Actions: If non-conformities or deviations from acceptance criteria are identified, take corrective actions to address them promptly. Document these actions, assign responsibilities, and verify their effectiveness.
11. Communication and Reporting: Communicate the results of monitoring and measurement activities, including compliance or non-compliance with acceptance criteria, to relevant stakeholders. Ensure that decision-makers are informed and can take appropriate actions.
12. Continuous Improvement: Use insights gained from monitoring and measurement activities to drive continuous improvement in the design and development process. Identify opportunities to refine designs, enhance quality, and meet customer expectations more effectively.

By incorporating monitoring and measuring requirements, as well as acceptance criteria, into the design and development process, organizations can systematically assess and validate the outputs, ensuring that they meet established criteria and are in line with customer and regulatory expectations. This promotes the delivery of high-quality products, services, or processes and contributes to overall customer satisfaction.

5) The organization shall ensure that design and development outputs specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision

Ensuring that design and development outputs specify the characteristics of products and services that are essential for their intended purpose and their safe and proper provision is a fundamental aspect of quality management and product/service development. This requirement emphasizes the need for clear and comprehensive documentation to guide the entire product/service lifecycle. Here’s how an organization can fulfill this requirement effectively:

1. Comprehensive Design Outputs: Ensure that design outputs include detailed specifications and descriptions of the characteristics that are essential for the intended purpose of the product or service. This should encompass both functional and non-functional requirements.
2. Safety Considerations: Specifically address safety requirements and characteristics in the design outputs. Identify potential safety hazards associated with the product or service and outline measures to mitigate those risks.
3. Legal and Regulatory Compliance: Verify that the design outputs align with applicable legal and regulatory requirements. Ensure that all necessary safety and compliance standards are met and documented.
4. User and Customer Needs: Incorporate the needs and expectations of users and customers into the design outputs. Consider usability, user-friendliness, and any specific requirements that enhance customer satisfaction.
5. Performance Criteria: Clearly define performance criteria and characteristics that relate to the functionality, reliability, efficiency, and durability of the product or service. These criteria should align with customer expectations and industry standards.
6. Environmental Considerations: If relevant, address environmental characteristics and requirements, including considerations for sustainability, resource efficiency, and environmental impact.
7. Interoperability and Compatibility: Specify any requirements related to interoperability with other systems or compatibility with existing infrastructure or products, if applicable.
8. Documentation Clarity: Ensure that the language used in design outputs is clear, unambiguous, and easily understandable by all relevant stakeholders, including engineers, production teams, and end-users.
9. Testing and Validation Plans: Develop plans for testing and validation that align with the specified characteristics and requirements. Outline the methods, criteria, and protocols to verify that the product or service meets its intended purpose and safety standards.
10. Supplier and Vendor Collaboration: If the organization relies on external suppliers or vendors, collaborate with them to ensure that design outputs align with their capabilities and requirements for production or service provision.
11. Documentation Control: Establish robust document control procedures to manage design outputs effectively. Ensure that all design-related documents are accurately maintained, updated, and accessible to authorized personnel.
12. Continuous Monitoring and Review: Continuously monitor and review design outputs to ensure that they remain aligned with the evolving needs and expectations of customers, industry standards, and regulatory requirements.
13. Training and Competence: Ensure that personnel involved in design and development activities are trained and competent to understand and implement the specified characteristics and requirements effectively.

By adhering to these principles and practices, organizations can develop design outputs that serve as a clear and comprehensive roadmap for the entire product or service lifecycle. These outputs ensure that products and services are not only fit for their intended purpose but also safe, compliant, and aligned with customer needs and expectations. This ultimately contributes to customer satisfaction and the organization’s success.

6) The organization shall retain documented information on design and development outputs.

These documents and records provide evidence that the organization has effectively completed its design and development activities and that the outputs meet the specified requirements. Here are the key documents and records required by Clause 8.3.5:

Documents:

1. Design and Development Specifications: Detailed specifications that describe the characteristics, features, and functionality of the product, service, or process. These specifications serve as a reference for subsequent stages, including manufacturing, testing, and validation.
2. Engineering Drawings: Technical drawings that illustrate the physical dimensions, tolerances, and configurations of components, assemblies, or systems. These drawings guide manufacturing and construction processes.
3. Prototypes and Models: Documentation of physical or digital prototypes and models that represent the final product or service. Prototypes are often used for testing, validation, and user feedback.
4. Design Plans and Strategies: Documentation of the overall design and development plan, including objectives, scope, resources, timelines, and risk assessments.
5. Test Plans and Procedures: Documents outlining the testing strategies, methodologies, and procedures to verify and validate the design outputs.
6. Change Requests and Change Orders: Records of any changes made to the design and development outputs, including reasons for the changes, approvals, and the impact on the project.
7. Technical Documentation: Comprehensive documentation that provides detailed information on how to build, operate, and maintain the product or service. This may include user manuals, installation guides, and maintenance procedures.
8. Supplier and Vendor Specifications: Specifications provided to suppliers or vendors for the procurement of components or services needed for the product.

Records:

1. Records of Design and Development Activities: These records demonstrate that the design and development process was carried out in accordance with the plan, including design reviews, verification, and validation activities.
2. Records of Design Changes: Documentation of any changes made to the design and development outputs, including change requests, change orders, and associated documentation.
3. Records of Verification and Validation: Evidence that design verification and validation activities were conducted and that the results met the defined criteria.
4. Records of Design Reviews: Documentation of the outcomes of design and development reviews, including findings, decisions, and action items.
5. Records of Prototyping and Testing: Records of any prototyping, testing, or validation activities, including test results, test data, and reports.
6. Records of Configuration Management: Documentation of changes made to design documents and the management of different versions and revisions.
7. Records of Corrective and Preventive Actions: Documentation of any corrective and preventive actions taken in response to problems, non-conformities, or issues identified during the design and development process.
8. Design History File (DHF): A comprehensive file that contains all the documentation and records related to the design and development process. It serves as a complete record of the design history.
9. Records of Training and Competence: Records demonstrating that personnel involved in the design and development process are appropriately trained and competent to perform their roles.

These documents and records collectively provide a complete and traceable record of the design and development process, demonstrating that the organization has fulfilled the requirements of ISO 9001:2015 Clause 8.3.5 and that the design outputs are in line with customer requirements, regulatory standards, and internal specifications. Proper documentation and record-keeping are essential for audits and assessments of the quality management system.