Questions regarding clauses 8.3 and 6.1

“The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services”.

My interpretation of this clause is; organisation should design and develop process FOR provision of products and services. The organisation I work for generate, transmit and distribute electricity. Am I wrong that the standard is not interested in the design of electricity but wants us to design and develop processes to provide that electricity and associated services?

Answer: The standard is referring to design and developing of products or services and not processes, so in case of your company you can exclude clause 8.3 from the scope of QMS. For more information, see: What clauses can be excluded in ISO 9001:2015? https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/

Clause 6.1 reads as thus; “When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed.

The reading of the clause gives me an indication that risks and opportunities should first be Determined in relation to the “QMS Processes defined” in response to clause 4.4 and then ACTION taken.

Please help me in interpreting these clauses 6.1 and 8.3

Answer: Organization needs to consider risks and opportunities emerging from the context of the organization and that includes he QMS processes. Actions to address risks and opportunities cannot be defined or taken without identifying risks and opportunities first.

For more information, see: How to address risks and opportunities in ISO 9001 https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/