This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.
Provide a design procedures manual. The design procedures must be based on fulfillment of the design specification.
The design procedure's scope begins with approval of the concept. No procedures document is required for exploratory activities. The procedures may differentiate between new product developments and product enhancements. Procedures may be established (and differ) on a per project basis.
Realistic and current plans for design and development projects must be created, documented and maintained.
PERT (Project Evaluation and Review Technique) charts, Gantt charts, resource requirements and schedules, time and cost estimates are typically included in these planning documents. The plans can be revised by increasing their level of detail as the project progresses. In any case the plans are to be realistic and kept current.
Plan the design, design review and test work. Assign qualified people to the design and verification work, based on their experience, education or training. Provide adequate resources to the people doing the work.
Written project plans define the assignment of specific work tasks to individuals. These tasks include both design work and verification work, that include conducting design reviews and testing activities. The individuals must have the capability to carry out their assigned tasks. Reference training records (see section 4.18) when making assignments. Provide adequate resources, including time, materials, equipment, safe work space, and information, to the people doing the work.
See that design information flows between groups both within development and between the development organization and the marketing, sales, manufacturing, service and other organizations involved with the product.
Hold design reviews involving test, manufacturing, services, marketing and other involved parties external to design and development. Keep records of these reviews.
Good communication between all departments is essential for good design and development. Make sure that the test, manufacturing, purchasing, service and marketing organizations as well as suppliers participate as true partners throughout the design and development phase.
Set down in writing the requirements for developing a product or service. Review the selection of features to ensure they are adequate for the intended use. If you don't understand the requirements, seek clarification from the person who wrote them.
Be sure you and your customer understand in detail what is to be designed and how it will be tested for acceptance.
The design stage results in development of specifications known as "design output". Design output must:
a) Satisfy design input requirements,
b) specify how to determine if the product meets the design output specifications,
c) meet safety, and other applicable regulatory requirements,
d) highlight safety and usage considerations.
Be sure the "blueprints" you create meet the customers' requirements. Be able to trace the customer requirements through the entire design process.
Test the final design against design input requirements. Plan the tests and carry them out by trained people. Use any of the following techniques to verify the design:
a) Holding and keeping a record of design reviews,
b) accelerated life cycle tests,
c) simulation of the equipment in operation,
d) design re-use.
Engineering design notebooks that show design calculations can be evidence of verification. These notebooks are an example of a quality record. Formal design reviews can also be used.
Maintain an orderly procedure for controlling design changes. This procedure must require the identification, documentation, review and approval of all design changes.
Design changes proposed in one component of a product should be evaluated for the effect on the whole product. The approval review typically involves the original designers. Integrate the design-change procedures into the design procedures.
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