The requirements of the amended ISO 9001:2015 remain applicable to small, medium, and large organizations alike, and such organizations should acquaint themselves with the clarifications in ISO 9001:2015. ISO/TC 176 has published a handbook “ISO 9001 for Small Businesses – What to do ?” giving specific advice to small businesses.
The requirements of ISO 9001 are applicable to small, medium, and large organizations alike. ISO 9001:2015 provides some flexibility, through clause 1.2 “Application”, on the exclusion of certain requirements for specific processes that may not be performed by the organization.
If, for example, the nature of your products does not require you to perform design activities, or if your product is provided on the basis of established design, you could discuss and justify the exclusion of these requirements with your certification/registration body (see also the ISO 9000 Introduction and Support Package module Guidance on ISO 9001:2015 clause 1.2 ‘Application’). However, individual organizations will still need to be able demonstrate their capability to meet customer and applicable statutory or regulatory requirements for their products, and will need to consider this when determining the complexity of their quality management systems.
Further guidance for small businesses may be found in the ISO handbook: ISO 9001 for Small Businesses – What to do, Advice from ISO/TC 176