ISO 13485 audit checklist about design and development


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ISO 13485 audit checklist about design and development
Clause 7.3

7.3.1 Design and development planning

• Documented procedures?
• Can you explain to me the process used by Organization to plan and control the design and development of product?
• What are the stages in the design and development process?
• How do you determine the review, verification, validation, and design transfer activities appropriate to each design and development stage?
• How/where are design and development responsibilities and authorities defined?
• How does Organization ensure effective communication and clear assignment of responsibility between different groups involved in design and development?
• As product design and development progresses, how are the planning outputs documented and updated?

7.3.2 Design and development inputs

• What are the design inputs relating to each of the following product requirements?
a) functional, performance and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
a) other requirements essential for design and development, and
d) output(s) of risk management.
• Where are they recorded?
• How & when are the design and development inputs reviewed and approved for adequacy?
• How does Organization ensure that requirements are complete, unambiguous and don’t conflict with each other?

7.3.3 Design and development outputs

• How can design and development outputs be verified against the inputs? (see 7.3.5q1) Are these outputs approved prior to release?
• Can you show me examples of design and development outputs and how they meet the input requirements?
• What outputs include information for purchasing, production and service?
• Where are product acceptance criteria specified?
• Where are product characteristics needed for safe and proper use specified?
• Where are records of design and development maintained?

7.3.4 Design and development review

• At what stages of design and development do you perform reviews to evaluate if the results meet requirements? (See 7.3.1q2b)

• Can you show me some problems that have been identified and actions proposed at these reviews?
• What functions (including specialists) are represented at these reviews?
• At each stage, are all functions concerned with that stage represented?
• Can you show me records of the results of the reviews and any necessary actions taken?

7.3.5 Design and development verification

• What verification activities are performed to ensure that the design and development outputs have met the input requirements? (See 7.3.3q1)
• Can you show me records of the results of the verification activities and resulting actions?

7.3.6 Design and development validation

• What design and development validation activities are performed to ensure that the product is capable of meeting the requirements for the intended use?
• Do records show that validation is done before product shipment?
• If not, is the justification recorded?
• Can you show me records of the validation activity results and any follow-up actions?

7.3.7 Control of design and development changes

• How are design and development changes identified? Where are the records kept?
• Are changes reviewed, verified, validated, and approved before implementation?
• Can you show me evidence that the review of design and development changes includes evaluation of the effect on component parts and products in the field?
• Can you show me records of the results of change reviews and any necessary actions?

Related documents:

ISO 13485 checklist

ISO 13485 standard

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