2 replies to this topic

[MOURADTALBI]

can someone explain to me the following requirement:

 

In the ISO9001: 2015 standard, the exclusion is not possible

also in BRC and IFS unless it is justified

 

In these cases we are talking about excluding a requirement of the standard or part of a trial or a whole process ie when I have 4 products manufactured (for example) can I delete a product scope of certification or not (or the exclusion in the standard means the exclusion of a standard requirement)

[will.merrill]

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.

[MOURADTALBI]

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

 

Thanks