8.3 Design & Development - Clause requirements for ISO 9001 design
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8.3 Design & Development - Clause requirements for ISO 9001 design
- 1. ISO 9001:2015 QMS 8.3 Design and Development of Products & Services
- 2. 8.3 Design and development of products and services 1. Design and development Input The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider: Functional andperformancerequirements; Information derivedfromprevious similar designanddevelopmentactivities; Statutory andregulatoryrequirements; Standardsorcodes of practicethat theorganization has committedto implement; Potential consequences of failure due to the nature of the products and services. Inputs shall be adequate for design and development purposes, complete and unambiguous.
- 3. 8.3 Design and development of products and services 2. Design and development planning In determining the stages and controls for design and development, the organization shall consider: a) thenature,durationandcomplexityofthedesignanddevelopmentactivities; b) therequiredprocessstages,includingapplicabledesignanddevelopmentreviews; c) therequireddesignanddevelopmentverificationandvalidationactivities; d) theresponsibilitiesandauthoritiesinvolvedinthedesignanddevelopmentprocess; e) theinternalandexternalresourceneedsforthedesignanddevelopmentofproductsandservices; f) theneedtocontrolinterfacesbetweenpersonsinvolvedinthedesignanddevelopmentprocess; g) the need for involvement of customers and users in the design and development process; g) the requirements for subsequent provision of products and services; g) the level of control expected for the design and development process by customers and other relevant interested parties; g) the documented information needed to demonstrate that design and development requirements have been met.
- 4. 8.3 Design and development of products and services 3. Design and development Controls The organization shall apply controls to the design and development process to ensure that: theresults to be achieved are defined; reviews are conducted to evaluate the ability of the results of design and development to meetrequirements; verification activities are conducted to ensure that the design and development outputs meet theinputrequirements; validation activities are conducted to ensure that the resulting products and services meet therequirements for thespecified application or intended use; Any necessary actions are taken on problems determined during the reviews, or verification andvalidation activities; documented information of these activities is retained.
- 5. 8.3 Design and development of products and services 4. Design and development Outputs The organization shall ensure that design and development outputs: meetthe input requirements; are adequate for the subsequentprocesses for the provision of products and services; includeor reference monitoring andmeasuring requirements,asappropriate, and acceptancecriteria; specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.
- 6. 8.3 Design and development of products and services 5. Design and development Changes The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements. The organization shall retain documented information on: Details of design and development changes; the results of reviews; the authorizationof the changes; the actions taken to prevent adverse impacts.