Design and Development In ISO 9001

by avinash v

The design and development phase in integrated management systems (IMS) gives companies the standards or processes set by ISO to develop products or services and meet customer expectations. The purpose is to ensure the design and development process across various organizational departments and groups and ensure effective collaboration. In some organizations, the design and development are outsourced where the third party fulfills the requirements of the procedure and meets the objectives.

Requirements for design and development

Requirements For Design And Development :

  • Resources: Proper identification of resources is the first and most crucial requirement. Ensure your organization has the provided resources needed for designing, implementing, and maintenance of products. Auditors need to take a deeper look if the resources are identified as per the budget allocated to avoid misuse of funds.
  • Workforce: Determine the number of people required for the successful implementation of design and development. Assign the most complex tasks to the highly experienced employees in your organization and record the resources or tools provided to assist them.
  • Infrastructure: Seek records and confirm your organization has a well-equipped infrastructure suitable for the design and development of the product. It can include machinery, safety gear, proper working conditions, etc.
  • Monitoring and measuring resources: Determine the measurement of raw materials used for creating a product. Ensure the size are as per the required ISO standards. The measurement instruments need to be adjusted as per the manufacturer’s instructions to avoid any misuse of resources.

Product and Service Supervision :

Control of products and services enables your organization to control the way products or services are being produced. The following are some supervision techniques:

  • Document information mentions the process followed to produce a product or service and ensure the objectives are met.
  • Resources required for quality checks and audits are made available when needed.
  • The review occurs at specific points or after regular intervals to ensure the process meets industry standards.
  • Personnel is skilled enough with the industrial process and possesses domain knowledge of the product or service.
  • Use a calibration procedure to determine the accuracy, precision, or both of a measuring instrument. The calibration process may be performed at any time to ensure that a tool is performing within its designed parameters and tolerances. Calibration procedures are used in manufacturing, scientific research and quality control laboratories for inspection purposes.

Nonconforming Products :

Nonconforming product is a growing problem in the manufacturing industry. When products do not meet quality and safety standards, it can be very expensive for the manufacturer. Therefore, ISO control of nonconforming processes is a common requirement for the management of any production process. The ISO standard guides designing and implementing such controls to meet these requirements. Here are some of the processes to control nonconformity:

  • Identify the nonconformity: You need to look at what is lacking and what can be done better, then figure out how best to do it. Figure out which ISO requirement was not followed before you move on to the next step.
  • Record: Record the nonconformity in a nonconformity report where you detail the violations and suggest some measures to fix it.
  • Control the nonconformity: This step should include an outline or a roadmap of actions to solve the nonconformity issue and prevent it from occurring in the future.

Steps in Design and Development Process

Handling Nonconformity Products in Design and Development :

  • The issue of nonconformity should be quickly addressed before it reaches the final stage of production and ensures the development runs smoothly. This will save the expenditure on making it relevant to the ISO requirements in the later stages of production.
  • If you cannot modify the product or services, the production needs to be eliminated, considering the nonconforming products or services.
  • Re-processed nonconformity products should be re-audited before release.

Steps in Design and Development Process

  • General requirement: This is the first phase where the need is gathered, and evidence is recorded for the design and development. Reasons behind making any changes and steps taken are documented. Any requirements not defined by the client or interested party should be clarified.
  • Planning: Once the requirements are gathered, the organization should effectively design and develop the product. This includes rigorous planning and brainstorming. Record evidence regarding the changes your organization has made related to the design and development process.
  • Design outputs: Once you complete the planning phase, the company will then move on to the design and development outputs. In this phase, the company prepares a design of the final product. It can be the written instructions or a sample diagram that will help create a final product.
  • Customer satisfaction: Conduct various feedback programs and distribute your products to a sample audience during your initial product launch stage. Ensure it solves their problems and takes corrective actions if the requirements are not met. Later use their positive feedback for marketing purposes.
  • Final stages: The final stages confirm that the product developed meets its requirements and that changes or solutions to problems are addressed. The product is tested keeping in mind the customer requirements and ISO standards. During the review process, the company goes through the past and future stages of the product development lifecycle.

 ISO 9001