ISO9001:2015 meaning of exclusion
We have excluded section 8.3 of the ISO9001:2015 Standard from our QMS because we do not do design or product development- it is a function performed by another segment of our company. So, after our brief scope ("at this facility we make these products for this industry") we have "Exclusion: Design and development of products and services, clause 8.3, are excluded from this QMS, as they are functions of corporate support services." Any similar statement should suffice... as long as you cite it up front and document it in your QMS. I've been through several audits here and it has never been a problem. If I remember correctly, the ISO auditors will inquire during the audit planning stages so they know about the exclusions before they arrive. Its best not to surprise them.
We have excluded section 8.3 of the ISO9001:2015 Standard from our QMS because we do not do design or product development- it is a function performed by another segment of our company. So, after our brief scope ("at this facility we make these products for this industry") we have "Exclusion: Design and development of products and services, clause 8.3, are excluded from this QMS, as they are functions of corporate support services." Any similar statement should suffice... as long as you cite it up front and document it in your QMS. I've been through several audits here and it has never been a problem. If I remember correctly, the ISO auditors will inquire during the audit planning stages so they know about the exclusions before they arrive. Its best not to surprise them.
Good informations
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