ISO 9001 Design Verification and Validation
Once product development work is complete and design outputs have been established, the product must be verified and validated (V&V) prior to the start of production and release to the customer. ISO 9001 design verification and validation activities contribute to an assessment of the integrity of the final product design and the design’s ability to meet design input requirements, user needs, and the product’s intended use. Successful completion of verification and validation activities results in a product proven to be safe and effective, and fit for release and distribution to the end customer.
ISO 9001 design verification and validation is generally accomplished by executing some form of test, measurement, observation, or analysis which demonstrates that the product meets predetermined acceptance criteria based on the design input requirements. If the product needs to meet a specific size or weight, then measurement of the product using approved measurement equipment should clearly demonstrate whether the product meets the requirement.
Note that various industries and standards have differing definitions for the terms verification and validation and your processes need to consider the needs and requirements of your customers when defining your verification and validation process requirements. If your organizations serve multiple industries with differing V&V requirements, your processes may need to be flexible to ensure they accommodate and satisfy each customer’s needs.
Design verification is the process of verifying through test, measurement, or observation that all design tasks have been completed according to established requirements, specifications, or other design inputs, and is carried out in accordance with applicable standards, regulations, and methods. In simple terms, verification demonstrates that the design outputs meet or satisfy the design inputs defined in the requirements specification.
Verification should be completed prior to release of product and product documentation for manufacture or installation to ensure that the:
- Design output conforms to specified requirements,
- Design has been completed in accordance with the appropriate procedures and standards,
- Design has addressed all outputs and issues from design reviews and risk analysis (FMEA?), including test results where appropriate,
- Supporting calculations and decisions for defined critical systems have been independently checked and verified,
- Where applicable, requisite approvals have been obtained from regulatory authorities (think medical device, aerospace, etc.),
- Design has been adequately documented (documented information).
Verification activities are conducted at all stages and levels of device design. Any approach which establishes conformance with a design input requirement is an acceptable means of verifying the design with respect to that requirement. In many cases, a variety of approaches are possible and their nature varies according to the type of design output.
Completion and approval of successful design verification is required before proceeding to process validation and design validation activities.
Design validation is the process of verifying through test, measurement, or observation that the final product conforms to user and customer specifications and requirements. It represents the final stage in the process of ensuring that a design is fit for its intended purpose before release of the item or system for use.
Design validation proves that the final design output specifications, the design (finished, packaged, and labeled product) will perform as intended and as users need. Design validation should be performed under defined operating conditions on initial production units, lots or batches, or their equivalents. Design validation includes testing of production units under actual or simulated use conditions. Design validation should address product packaging and labeling, and also includes software validation and risk analysis, where appropriate, as these components of the design may have significant human factors implications and may affect product performance in unexpected ways.
Verification & Validation Links
As with most other design and development processes, the ISO 9001 design verification and validation requirements do not stand alone as isolated processes, but is strongly integrated with many other D&D processes.
- Design & Development Plan: The overall D&D Plan should include the Design Verification & Validation Plan which defines goals & objectives, assumptions & constraints, scope, resources, test methods, acceptance criteria, V&V protocols, procedures, deliverables, approval requirements, etc.
- Design & Development Inputs: The Design Input Requirements form the basis and criteria to be satisfied during V&V activities. Failure to meet these established specifications constitutes a failed verification or validation and this must be reconciled and addressed prior to final production and product release.
- Design Outputs: The Design Outputs constitute the actual product to be verified and validated. The design outputs should clearly define the “essential requirements” or product characteristics essential to the products safe and effective use.
- Design Reviews: Design reviews often identify new or critical product requirements or characteristics which must be incorporated into the product design and associated design verification and validation activities.
- Design Changes: Any change to the product or product design must consider the impact to the product and determine the need to re-verify or re-validate the design.
- Risk Assessment: The results of risk assessment activities (risk analysis, FMEA, FTA, etc.) often provide high-risk design characteristics and issues that warrant the need for design verification and validation efforts. Be sure to incorporate high-risk issues into design input requirements, design reviews, and design V&V activities.
Process Validation and Controls
Process validation and ISO 9001 design verification and validation are very much intertwined and linked. Product used for design validation should be produced by a validated production process, or as is often seen, product produced during process validation is used for design validation activities. This approach kills two birds with one stone, but also adds risk to the project. If the process validation fails, the product most likely cannot be used for design validation purposes. Also note that in some cases, testing completed for process validation may also satisfy some of the testing requirements for design verification or validation.
The results of process validation should inform the required process controls to be implemented within the production process. Based on process validation results and other inputs such as process FMEA or other risk assessment results, determine what type and level of controls are to be implemented to ensure all production processes are under control and process outputs are compliant to established specification.
Design V&V Alternatives
Please note that the guidance information provided above is a more traditional approach utilized by many OEMs or tier one providers in complex or regulated industries. For smaller less-complex or non-regulated organizations, verification might well be accomplished by basic bench or prototype testing, first article analysis, and demonstrated completion of design requirements. Validation might be satisfied by demonstrated performance and functionality against product or technical requirements. Again, the level and nature of the verification and validation activities within your organization should be dictated by the complexity and risks associated with your products and the needs and requirements of your customers, users, and the general industry in which you operate.