8.0 Operation

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8.3 Design and development of products and services

8.3.5 Design and development outputs

This requirement is comparable to the requirement from ISO 9001:2008 Clauses 7.3.3 – Design Development Outputs. You should seek and record evidence that the additional requirement to retain documented information concerning design outputs. You should also check the need for design outputs to reference monitoring and measuring requirements.

The design and development output is the result of design and development process. The output is a clear description of the product, containing detailed information for production. Ensure that your organization's design and development outputs reconcile with its design and development inputs by:

  1. Ensuring outputs meet input requirements e.g. checklists, design review records, authorization to proceed, customer acceptance, and product certification;
  2. Ensuring outputs are adequate for product and service provision e.g. standards, specifications, schemes, drawings, models, part lists, materials, methods, manufacturing instructions, technical packages, tooling, machine programs, preservation, handling, packaging, specialist training, user instructions, service manuals, repair schemes, and external provision;
  3. Reference to monitoring and measuring equipment e.g. inspection equipment, gages, instruments, environment;
  4. Acceptance criteria e.g. product/service specification, limits, tolerances, and quality acceptance standards;
  5. Product/service characteristics e.g. key characteristics, customer critical features, interface features, inspections, service intervals, and operating characteristics;
  6. Critical items such as identification, key characteristics, special handling, service intervals, component lifing, cyclic life, life management plans, source and method change, and traceability;
  7. Outputs are approved prior to release e.g. scope of authorization, authorized persons, levels of authorization, method of authorization and documented information is retained.

A Certifcation Auditor would expect to see objective evidence that the outputs have been verified against the design inputs. This can be accomplished by reviewing documents, plans, etc. interfacing with the customer or internal processes and by comparison with past proven designs. Outputs may also include product preservation methods, identification, packaging, service requirements, etc. as appropriate.

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