K. R. SINGHAL
ISO 9001:2008 QMS standard referred the exclusions by providing that where any requirement(s) of ISO 9001:2008 QMS standard cannot be applied due to the nature of the organization and its product, this can be considered as exclusion and such exclusions are limited to requirements within clause 7 only and not permitted in other clauses of the standard.
Forthcoming ISO 9001:2015 QMS standard does not refer to exclusions in relation to applicability of its requirements to the organization's quality management system. All the requirements of ISO 9001:2015 are generic and applicable to the organization, regardless of its type or size, or the products and services it provides. However, an organization, implementing ISO9001:2015, needs to determine the boundaries and applicability of the quality management system to establish its scope, that needs to be available and be maintained as documented information.
Accordingly, if an organization determines that any ISO 9001:2015 QMS requirement is not applicable to the organization's scope, then organization (i) needs to provide justification for the non-applicability, and (ii) ensure that the requirements determined as not being applicable do not affect the organization's ability or responsibility to provide products and services that meet requirements to enhance customer satisfaction.
In this way, we see that ISO 9001:2008 allowed the exclusions within clause 7 only, while ISO 9001:2015 does not mention such limitation to non-applicability of requirements.
International Organization for Standardization (ISO) has released ISO/FDIS 9001:2015 for voting to be completed on 9 September 2015 and thereafter ISO 9001:2015 QMS standard will be published. This article is based on the draft versions of the forthcoming standard and there may be some changes after the final standard is published.