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To me, QA is planning for quality ("providing confidence") and QC is monitoring for

quality ("fulfilling quality").

So, all the clauses and sub-clauses related to planning and risk management are QA,
and inspection, monitoring & measuring, corrective actions, etc. are QC.

In crude generalizations, I'd say clauses 4-7 involve QA, 8 involves both QA & QC,
9-10 involve QC (except 10.3).

Another perspective could be to say that the entire standard is QA (i.e., the whole
idea of 9001 is as a framework to provide confidence for quality), and part of that
QA is to establish QC at certain points.

http://www.relevantbusinesssolutions.co.uk/iso-90012015-clause-8-1-operational-
planning-control-explained/

Prior to ISO 9001 there was MIL I. It dealt with a heavy duty inspection program.
Basically it dealt with 8.2.4 of ISO 9001:2008 and 8.6 of ISO 9001:2015. The goal
was to be sure not to ship any xxxx (substitute your own four letter word for
nonconforming product).

ISO 9001 added continual improvement to the equation, and in so doing involved most
everything else in the organization.

Quality cannot be inspected into a product. It is the results of many decisions


along the way. Those decisions involve the entire ISO 9001 standard and the
attention of the entire organization.

Main elements shall be defined and stated in ITP (as a minimum requirement):
PROCESS DESCRIPTION - to describe the process to be inspected/tested;
Example: - Material Receiving
- Welding
ACTIVITY � to describe the more detail activity under the process described;
Example:
- under Material Receiving: Check material certificate
- under Material Receiving: Visual & Dimensional Check
- under Welding: Check welding electrode
- under Welding: Check Fit-Up Joint
PROCEDURE � applicable procedure to perform the activity. It would be a common
standard/code or project/company�s procedure.
ACCEPTANCE CRITERIA - Specified indicators or measures at which the product
has to meet.
FREQUENCY � the oftenest, or the rate of repetition of a cyclical or regular event
of inspection. It will be in Percentage (%) or per Heat/Batch or any numbers of
inspection/check required as per standard.
INSPECTION INVOLVEMENT LEVEL � defines the level of inspection shall be
performed by all parties involved in the project. The parties maybe consist of:
SUPPLIER, CONTRACTOR, THIRD PARTY and CUSTOMER/CLIENT/COMPANY.
The Inspection Level in the ITP :
o Spot Witness: an activity during manufacturing, fabrication or construction
where witnessing of work or inspection normally takes places without any formal
written notification, although oral or informal memo will normally be given. If the
inspector does not inspect the work at this point, the work may continue. However
the inspection result must be recorded. In any cases, the CUSTOMER/CLIENT/COMPANY
or his/her designate or the appointed THIRD PARTY shall have the right to inspect
any works done by SUPPLIER/CONTRACTOR at any time.
o Witness: an activity during manufacturing, fabrication or construction, where
the inspection and measurement or tests must be done in place and documented. Prior
to the inspection, measurement or test; SUPPLIER/CONTRACTOR is required to notify
the CUSTOMER/CLIENT/COMPANY or his/her designate or the appointed THIRD PARTY who
normally will attend the inspection. In case the CUSTOMER/CLIENT/COMPANY could not
attend the inspection/test, the inspection may proceed; however the inspection
result must be recorded and submitted for review and approval.
o Hold point: an activity during manufacturing, fabrication or construction,
where the inspection, measurement, or test must be done in place with mandatory
attendance by CUSTOMER/CLIENT/COMPANY or his/her designate or the appointed THIRD
PARTY. SUPPLIER/CONTRACTOR cannot proceed with the next work step activity until
the inspection, measurement or test has been witnessed and approved by all
attending parties. Prior to the inspection, measurement or test;
SUPPLIER/CONTRACTOR is required to notify the CUSTOMER/CLIENT/COMPANY or his/her
designate or the appointed THIRD PARTY who normally will attend the inspection.
After the inspection/test, the inspection result must be recorded and submitted for
review and approval.
o Review or Approval: review or approval to the documentation or record of the
inspection/test/measurement had performed.

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