What can an organization do if it is not able to comply with all of the requirements of ISO 9001?
ISO 9001 allows for the exclusion of some of its requirements (via clause 1.2 “Application”), but only if it can be shown that these requirements are not applicable to the organization. Exclusions are limited to the requirements given in Section 7 (“Product Realization”), where individual requirements may only be excluded if it can be shown that they do not affect the organization’s ability to provide product that meets customer and applicable statutory or regulatory requirements. Justification for such exclusions is also required to be detailed within the organization’s quality manual. For example, if design activities are not required by an organization to demonstrate its capability to meet customer and applicable statutory /regulatory requirements, or if its product is provided on the basis of established design, then it may be able to exclude some of the “design” requirements but still be able to be registered/certified to ISO 9001:2008.
ISO 9001 allows for the exclusion of some of its requirements (via clause 1.2 “Application”), but only if it can be shown that these requirements are not applicable to the organization. Exclusions are limited to the requirements given in Section 7 (“Product Realization”), where individual requirements may only be excluded if it can be shown that they do not affect the organization’s ability to provide product that meets customer and applicable statutory or regulatory requirements. Justification for such exclusions is also required to be detailed within the organization’s quality manual. For example, if design activities are not required by an organization to demonstrate its capability to meet customer and applicable statutory /regulatory requirements, or if its product is provided on the basis of established design, then it may be able to exclude some of the “design” requirements but still be able to be registered/certified to ISO 9001:2008. For further guidance, see the ISO 9000 Intro
ISO 9001 allows for the exclusion of some of its requirements (via clause 1.2 “Application”), but only if it can be shown that these requirements are not applicable to the organization. Exclusions are limited to the requirements given in Section 7 (“Product Realization”), where individual requirements may only be excluded if it can be shown that they do not affect the organization’s ability to provide product that meets customer and applicable statutory or regulatory requirements. Justification for such exclusions is also required to be detailed within the organization’s quality manual. For example, if design activities are not required by an organization to demonstrate its capability to meet customer and applicable statutory /regulatory requirements, or if its product is provided on the basis of established design, then it may be able to exclude some of the “design” requirements but still be able to be registered/certified to ISO 9001:2000.
ISO 9001 allows for the exclusion of some of its requirements (via clause 1.2 Application), but only if it can be shown that these requirements are not applicable to the organization. Exclusions are limited to the requirements given in Section 7 (“Product Realization”), where individual requirements may only be excluded if it can be shown that they do not affect the organization’s ability to provide product that meets customer and applicable statutory or regulatory requirements. Justification for such exclusions is also required to be detailed within the organization’s quality manual. For example, if design activities are not required by an organization to demonstrate its capability to meet customer and applicable statutory /regulatory requirements, or if its product is provided on the basis of established design, then it may be able to exclude some of the “design” requirements but still be able to be registered/certified to ISO 9001:2000. For further guidance, see the ISO 9000 Introdu
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- What can an organization do if it is not able to comply with all of the requirements of ISO 9001?
