Hi there. My company is a reseller of COTS Information Technology equipment and software. We take orders from enterprise and government, then purchase and resell from OEMs and authorized distributors. All product is drop shipped from OEM/distributor to customer. I have a few questions:
1) Can we exclude clauses 7.1.5, 8.3, 8.5.1?
2) Does anyone have a sample quality manual for this type of company (I'm struggling with 8.5.1)
Thanks so much!
Good day
@qualitygal ;
1- ISO 9001 allows for "exclusions" (the term is now applicability) to any part of the standard, which...
A.5 Applicability
This International Standard does not refer to “exclusions” in relation to the applicability of its
requirements to the organization’s quality management system. However, an organization can review
the applicability of requirements due to the size or complexity of the organization, the management
model it adopts, the range of the organization’s activities and the nature of the risks and opportunities
it encounters.
The requirements for applicability are addressed in 4.3, which defines conditions under which an
organization can decide that a requirement cannot be applied to any of the processes within the scope
of its quality management system. The organization can only decide that a requirement is not applicable
if its decision will not result in failure to achieve conformity of products and services.
2- I would caution about being biased (potentially) by "someone else's...". Keep in mind, there is no need/requirement by ISO 9001 for a "quality manual". In fact, ISO 9002:2015 (current) version, does not even require "procedures" as did previous versions.
Summary:
Do what is best for YOUR organization. ISO 9001 prescribes very little in regards to HOW the standard is met. Take a look at what your organization already does, and then reverse engineer that towards what the standard requires. Most established/sustaining organizations "meet" most of the ISO 9001requirements. The goal is to simply identify any gaps and correct them, and "capture"/articulate how your organization meets the applicable aspects of the standard. While it is not possible for me/"us" to know exactly which aspects of the standard may not be appicable to the scope of your organization, it does seem (based on what you describe), that 7.1.5 and 8.3 may not apply. However, 8.5.1 encompasses operational control. I can not see how all aspects of clause 8.5 would not apply. This section requires your organization to consider how it controls what it DOES do...(regardless of what that is).
Hope this helps.
Be well.