Clause 8 Operation
8.3.6 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:
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.
It is important that the organization provides for formal control of changes to design specifications, throughout the design and development process.
How the organization implements changes, with ongoing reviews, validations and authorizations, should be clearly documented to support conformance to this set of criteria.
Every organization will have its own set of criteria, or code of practice, to govern its design and development process, in which changes to design specifications will feature strongly. If you and your team need a little help or guidance on the application of this clause to your organization, please contact us through the contact page, or the chat box to the bottom right of the website.
Note: Architectural practices, adhering to The Royal Institute of the Architects of Ireland (RIAI) codes of practices, can benefit from the Enable ISO Total Management System, with ready-to-go templates for auditing this critical aspect.
Note: Software engineering organizations, adhering to Disciplined Agile Delivery methodologies, can benefit from the Enable ISO Total Management System, with ready-to-go templates for auditing this critical aspect.