Design & Development is one of the most important processes in an organization. It has been recognized by the ISO 9001 Quality Management Standard and special requirements have been elaborated for conducting Design & Development of product or service in any organization.
The standard says that the Design & Development process should be able to meet the subsequent requirements and delivery of products or services.
There should be a systematic process for controlling design & development. That will involve design planning which shall include stages of design, review, verification and validation. Commonly a design plan is developed to write down all the stages which are given in the section below.
Design & Development Planning
While devising the stages and controls for design & development process the organization has to consider the following:
- The complexity, nature and duration of design & development process
- The stages that are required including reviews
- The verification and validation (verification of actual resulting prototype product characteristic) activities required
- Responsibilities and authorities of personnel who are involved in this process
- Resources that are needed for this process including internal and external resources
- Requirement to control the interface between different persons involved
- Need to involve the customers and users input in the process
- Finding out the requirement for the subsequent provision of products and services
- The control level expected by customers and other relevant interested parties over the design & development process
- Documented Information that is required e.g. Procedure and Records for demonstrating that design & development requirements have been met
Review of design should be taken at planned intervals to make sure that the design is satisfactory and to find out solutions to any problems that are encountered. Records of reviews can include minutes of meetings, altered sketches and drawings and approval documents.
Verification is a process where the design is checked to make sure that what has been designed meets the input requirements. Records of verification can include alternative calculations, approvals and comparison reports. Example can be checking the design calculations if a refrigerator can perform at desired level at a high external temperature of the environment.
Validation is performed on the actual or prototype product to find out that it meets the requirements. Records can include test results, prototype feedback, user testing etc. validation shall be conducted before delivery of product to customer. An example can be testing a prototype refrigerator to see if it can keep the food stuff inside at a required coldness for an extended period of time.
Design & Development Inputs
The organization has to find out the requirements for design & development inputs for the specific type of products and services. At a minimum the following have to be considered:
- Functional and performance requirements of products and services
- Information collected from design and development activities by the organization in the past
- Statutory and regulatory requirements meaning legal requirements for the product or service to comply
- Product and business performance standards or codes of practice that the organization has committed to implement
- Potential consequences and results of failure.
- The inputs for the design process shall be adequate for the purpose and complete and unambiguous
- The organization shall resolve conflicting inputs
- The organization shall retain records of the design & development inputs
Design & Development Controls
For ISO 9001 certification the consultants are required to advise their clients based on an internal audit conducted for 9001 for adopting some controls for the design & development process. They are
- Define the results to be achieved
- Evaluate the ability of the results design & development to meet the requirements through a review
- Verify that the design & development outputs meet input requirements
- Conduct validation activities on the subsequent product or service to ensure that they meet the requirements for intended use or application
- If any problems are detected during review, verification and validation then appropriate action is taken
- Records are kept of the above activities
Review, verification and validation have different purposes. They can be done separately or in any combination.
Design & Development Outputs
ISO 9001 requires the organization to ensure that design & development outputs
- Meet the input requirements
- Are sufficient and adequate for the subsequent provision of products and services
- The outputs include or give reference to monitoring and measuring requirements and acceptance criteria
- Spell out the characteristics or attributes and functions of the product or service thatnecessary for its intended purpose.
- Records shall be kept of these activities
Design & development changes
The organization shall keep track of changes made during the design & development process and ensure that there is no negative effect on the conformity to the requirements.
The organization shall keep records of
- Design & development changes
- Result of review of changes to designs
- Authorization of changes to design
- The action taken to prevent adverse impacts of Design & Development changes.
The organization may also decide to review, verify and validate design & development changes where required.
If you are looking to get ISO 9001 Certification, you may need the services of a specialist ISO 9001 Consultants who can guide you through the requirements of the ISO 9001 Quality management system standard and help you identify the requirements around design and development correctly as this can have a huge impact on the organization’s strategy for survival and growth.