Auditing of Design activities in ISO 9001 Scopes (07/05/2021)

Thank you to those who attended our meeting on 6th May 2021 to discuss UKAS’ recently published article on the auditing of design activities in ISO 9001 scopes [UKAS article]. It was great to get the input from such a wide range of Atlas’ interested parties which has allowed us to reach some conclusions in respect to future ISO 9001 audits.

In addition to the above link to the UKAS bulletin, our focus is primarily on the following statement made by UKAS:

“Often in the past design has been considered to refer only to product design and exclusions were claimed on this basis, however in many instances, organisations did in fact carry-out design of processes and services.

With this change of emphasis on design within an organisation’s Quality Management System, a claim that an organisation is not involved in design in any way is now less likely.  Therefore, certification body auditors should be mindful when considering the boundaries of a client’s QMS, taking account the design of their processes and services as well as products, so as to ensure that the organisation’s activities relating to such design are fully understood.”

UKAS bulletin dated 11th January 2021

During ISO 9001 audits, where the client has declared Cl. 8.3 as not applicable in their scope, please conduct a review of this based on the client’s scope, processes and activities. Remembering to note that even clients within the service industry will carry out a degree of design in respect to the services being provided to their clients. Where such clients have determined that Cl. 8.3 is not applicable, an Action must be raised during the audit so that the client can take appropriate corrective action to adjust their quality management system accordingly.

If you have any questions about this topic or need further guidance, please contact Gary Jones.