Company Name Division or Address Division or Address

Design Control Doc. No. Date: -

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ISO Procedure

Design Control
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Change Record Rev A Date Responsible Person Name Description of Change Initial Release

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1.

Purpose To control the design and development of new products. To define the checks and balances applied to the design and development activity. To control and verify the design of the products, assign design function responsibilities, define technical interfaces, ensure that the product meets the specified requirements, and verify that the design output meets the design input requirements. To expose the product design to persons with viewpoints and opinions other than those of product design and development engineers. To re-evaluate distributed products. To maximize protection against oversight that might adversely affect product quality, safety, and efficacy.

2. Scope

This procedure applies to the development of all new products from the initial design to the release for manufacturing. 3. Responsibilities <Job title> approves the product specification for major new products, product revisions, and accessories. <Department> evaluates performance, durability, safety, reliability, and maintainability of the design under expected storage and operational conditions; verifies that all design features are as intended and that all authorized design changes have been accomplished and recorded; validates computer systems and software. <Department> provides initial product requirements, performance target values, and market utility assessments. <Department> ensures the availability of products and services required for the manufacturing and testing of the product. <Department> advises and reviews necessary testing and inspection requirements. <Department> ensures that sufficient personnel are available and suitable for the production of the product, and that an appropriate training program is instituted.
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<Department> ensures that the facilities, instrumentation, machinery, equipment, and services are available for the efficient production of the product. <Department> tracks revision levels and changes to preliminary drawings. <Job title> approves revisions to preliminary drawings. <Job title> coordinates: the design and production of sketches, drawings, and layouts the building and testing of models, prototypes, and pilots, including the acquisition of materials the collection and recording of test data any modifications to the product specification, if necessary

At all stages of development, <team> representing <departments> may determine whether to modify the product specification or change the design of the product based on test results. 4. Procedure 4.1 Review Team See Contract Review xxx. <Job title> translates the customers needs into technical specifications. <Team> composed of <job titles> reviews the specification and ensures it is producible, verifiable, and controllable. <Team> generates a design plan identifying activities and assigning responsibility to the activities. Those assigned to perform design activities meet company qualifications. <Records of qualification> are stored as Quality Records at <location>. <Team> meets <activities>. <Records> of <team> meetings are maintained as Quality Records. <Job title> maintains the records for <length of time> in <location>. 4.2 Market Review <Job title> can initiate a concept for a new product. Features of a new product are based upon <information>. 4.3 Product Definition See Document and Data Control xxx.

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<Job title> develops preliminary drawings. <Job title> approves the preliminary drawings. Customer requirements are incorporated into the design. <Department> communicates the requirements to the design team through <activity>. Design of product includes the applicable statutory and regulatory requirements to which <Company> adheres. <Job title> generates <document> to support the design. The documents are controlled and maintained by <department>. 4.4 Qualify and Verify See Quality Records xxx. <Job title> is responsible for testing the new design and records test results on <name of form>. The <name of form> is maintained by <department> for <length of time>. <Job title> reviews the test results and if required the preliminary design drawings are revised. The preliminary drawings are released for a pilot run. <Job title> evaluates the pilot run. The test procedures specify the following <criteria> and include: <types of analysis>. <Job title> records the test results onto <name of form>. The <name of form> is maintained by <department> for <length of time>. 4.5 Final Review A final review to determine if the product meets the requirements of the product specification is held by <team>. <Job title> qualifies the pilot run determining if the product meets the requirements of the product specification. Subcontracted, suitably qualified facilities are used for specialized testing. The review includes <criteria>. The <name of form> releases the design to production. <Job title> approves the <name of form>. The <name of form> is maintained by <department> for <length of time>.
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4.6

Requalification Periodically the product is re-evaluated to ensure that the design is still valid with respect to all specified requirements. The review includes: <criteria>. Records of the re qualification are maintained on the <name of form>. <Job title> approves the <name of form>. The <name of form> is maintained by <department> for <length of time>.

4.7

Revision Control Design changes are given the same review as the initial design. <Job title> reviews changes and modifications to the design of the product. <Job title> revises the documentation.

5.

Related Documentation <record of meetings> <design plan> <form for qualification> <test procedure> <training records> Contract Review Document and Data Control Corrective and Preventive Action Quality Records Training <list of work instructions>

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