Applicability, Design, and Development.  

Different approaches are used to determine the applicability of design and development in management systems and certification scopes, so it is necessary to understand the intent of the standard’s requirements. 

ISO 9000 defines Design and Development as the set of processes that transform requirements for an objective into more detailed requirements for that objective.  

The requirement generally intends to ensure that the organization establishes, implements, and maintains a design and development process to ensure that products or services meet the requirements defining their characteristics.  

The requirements to be considered in the design and development process are as follows: 

a) Design and development planning to determine the activities and tasks required. 

b) When determining inputs for design and development projects, these inputs must be unambiguous, complete, and consistent with the requirements that define the characteristics of the product or service.  

c) Design and development controls and review, verification, and validation activities are essential to control the design and development process.  

d) Ensure that design and development outputs precisely provide the necessary information to all processes required to deliver the intended products and services. 

e) Determine, review, and control changes made during or after the design and development.  

Upon further review of these requirements, organizations could determine the applicability of all, some, or none of the requirements of the Design and Development section. For example, they could consider only the requirements for design and development changes or not consider any requirements of the Design and Development section because all product specifications come from a customer.  

Some criteria that could help determine the applicability of the Design and Development requirements in organizations are:  

• When the organization has the ability to offer new products or services to its customers; or modify the characteristics of those it is already offering, the design and development requirement becomes applicable. 

• When the organization owns the intellectual property of the product or service, Design and Development are applicable.  

• Adjustments in the process are not design and development.  

• In management systems, design, and development are synonymous  

• Design and development are exclusive to products and services, not to processes.  

• Sections may be excluded from the design and development requirements, even if they apply to you.  

• Design and development are sets that cannot be applied separately. 

• When design and development are not applicable in the scope of the management system, the scope of certification cannot refer to the word design and development, or design or development, even if they are found in the name of a main process of the organization.  

• Design and development do not apply to product packaging processes in non-functional packaging. 

• Design and development do not apply to maquiladora plants. 

• The following terms may be included in the scope of the certificate when design and development apply: 

• Design of… 

• Development of… 

• D&D of… 

• Design Management… 

• Provision of D&D Services of…

• Course development… 

Note: The terms scope of the quality management system and scope of certification are not the same; the former is based on the nature of the organization’s products and services for which the organization decides to implement the requirements of the standard; it includes the processes and activities for the realization of the final product or service delivery, while the scope of certification is a term used to refer to the scope in the certification document (certificate). Usually, it is a statement that describes the “type of activities, products, and services applicable at each site without being misleading or ambiguous.” 

References:  

ISO 9001 Auditing Practices Group (ISO & IAF) – Guidance: Design and Development Process 

ISO 9001:2015 Quality Management System 

Guide for the application of UNE-EN ISO 9001:2015 

ISO/TS 9002:2016 Guidelines for the implementation of ISO 9001:2015. 

ISO 9000:2015 Quality Management System – Fundamentals and