Blog, ISO 9001 Quality System

Design Control Principles for Total Quality Control

One of the basic principles of Total Quality Control is to begin the process of quality control at the design concept phase. Utilizing this approach assures clear communication with customers through out the development process and facilitates rapid movement from design to implementation.Design Control

Product concepts are developed and evaluated against the criteria of meeting the market requirements. Defining the market requirements for the product includes user intended use as well as the regulatory and legal requirements of the product. Gathering marketing information on the user requirements should not be overlooked. Developing a product which does not meet the customers’ requirements will ensure trouble down the road. Take the time to talk with the end users.

ISO 9001 section 7.3 Design and Development references seven process steps to follow to ensure the compliance of the products development life cycle.

These requirements are as follows:

  1. Design and Development Planning
  2. Design and Development Inputs
  3. Design and Development Outputs
  4. Design and Development Review
  5. Design and Development Verification
  6. Design and Development Validation
  7. Control of Design and Development Changes


Planning is sometimes viewed a road block for the design team. Having a good plan is half the battle. Assign a Project Manager to create a plan which lists all the tasks that must be accomplished, assigned responsibilities, and set achievable deadlines. Communicate the updated plan throughout the development cycle. The Project Manager needs to keep the team on task and account for the successful completion of the activities.


Once you have a good understanding of the end user requirements, regulatory and legal requirements, it is time to document your design input requirements. Design input requirements will drive the product specifications. Design inputs must be defined before beginning the development of the product. Design to the specifications and end use requirements.

Design inputs should include but not limited to the following:

  • Product Intended Use
  • Functional Specifications, Performance Specifications
  • Physical or Chemical Characteristics
  • Human Factors
  • Safety, Customer, Regulatory or Legal Requirements
  • Customer Specifications
  • Software Requirements
  • Labeling Requirements
  • Risk Management


Design outputs are the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the design history file. Every design input requires a corresponding design output. Each design output shall be documented and expressed in terms that can be verified and validated against design input requirements. The design outputs must contain or make reference to acceptance criteria. The design output should be examined against characteristics related to safety, labeling, packaging, materials, and manufacturing processes to determine if they have been addressed appropriately.

Design Review

The purpose of a design review is to document a comprehensive, systematic examination of a design against the design requirements, to evaluate the capability of the design to meet these requirements, to review and update the plan, to identify problems and actions items. Conducting periodic design reviews throughout the project will keep the project team on task as well as insuring the end product design will meet the original design intent.

Verification and Validation

Design verification is a confirmation that the design output meets the design input requirements. This is accomplished by examination and objective evidence that the design input requirements have been fulfilled. While, design validation establishes by objective evidence that the product conforms to user needs and intended use(s). The validation process is typically conducted after the design verification. The validation process is to be conducted on product that is intended for distribution or the design that represents the equivalent design and final processes found in the product to be distributed. Validation testing should be conducted under actual operating conditions or simulated use environments.

Design Changes

Design changes will always occur once the design and specifications are released. A review of design changes shall include evaluation of the effect of the changes on constituent parts and product already delivered to the customer. Following the design control process is imperative when making a design change to assure the changes will not negatively affect the intended use of the product.

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