Audit by Process Method

How the Audit is How this could be

Identified documented Document review Perform the audit
For an organization-specific For an organization-specific
Audits are identified The Quality Manual is a "road process, review documentation process:
by Process name. map." It will tell you which of for the process. 1. Is the organization's
the following methods is used. documentation followed?
The process could If the process relates to an ISO
have the same name The Quality Manual will fully clause for which there is a Plus
or similar name as written procedure or method: 2. Use the Universal Items
describe how the process is
Review the written explanation Checklist to determine if the
an ISO clause. performed and who is
for the Clause in Manual 1 ISO requirements of other
responsible for doing what. Requirements ISO 9001
OR processes that apply to this
Explained Adobe PDF computer process are being met.
The process could OR file This tells you what the ISO
be an organization- The Quality Manual will make a Clause requirements mean. If the process relates to an
specific process. summary statement and make a ISO requirement clause and is
reference to an Operating Then, use the ISO 9001-2008 documented:
The Audit Assignment Procedure that describes how Checklist questions to determine:
Does the Quality Manual or a 1. Use the questions for the
tells the numbered the process is performed and Clause from the ISO 9001-2008
who is responsible for doing referenced document or method
paragraph in the Checklist. Read the instructions
what. (in any format) include how each
Quality Manual where for using the Checklist.
ISO clause requirement is met?
the process is Is the organization's method for
described or provides OR Your audit checks to see if the meeting the ISO requirements
the name of the The Quality Manual will make a ISO requirements of other being followed?
document that
summary statement and tell processes that apply to this Plus
who is responsible for the process are being followed.
describes the process. 2. Use the Universal Items
process and make a reference Use the Universal Items Checklist Checklist to determine if the
to the method that is used to to check for ISO requirements
The Quality Manual or ISO requirements of other
a referenced Operating
control the process -- for that apply. ISO clause numbers processes that apply to this
procedure or document example, forms used or a are listed in the left column. process are being met.
MUST identify software program that is used Write N/A in the Comments box if
processes that interact to carry out the steps of the a question does Not Apply to the For all audits:
process. process. Identify any nonconformances
with this process.
found. Have someone confirm
On the last page of the Universal that this is a nonconformance by
The Audit assignment Items Checklist, identify ISO signing your paperwork.
(or process clauses (that are not on this
documentation) must Checklist) that have requirements Put an X in the right margin of
identify the ISO clauses that this process must follow. List your paper at the location of a
that contain one or what these ISO requirements are nonconformance. This helps
more requirements that that this process must follow. you locate the item when writing
apply to the process. Check these items during the the audit report
audit.
OR Your audit checks to see that the If the process is not
If the process is NOT The Quality Manual will state, ISO requirements that apply to documented:
DOCUMENTED, "We do (whatever the process 1. Interview the person who
the process are followed.
DO THIS does)," identify who is performs the process. Ask the
Use the Universal Items Checklist person to describe how the
(Read across the responsible for the process, to check for ISO requirements process is performed. Write
page.) and what processes interact that apply. ISO clause numbers down how the process is
with the audited process. are listed in the left column. performed as the person
The Audit Assignment
Write N/A in the Comments box if describes it.
(or process
a question does Not Apply to the
documentation) must 2. Observe the process being
process.
identify the ISO clauses performed (if possible) to see if
that contain one or On the last page of the Universal
what is done matches the verbal
more requirements that Items Checklist, identify ISO
description.
apply to the process. clauses (that are not on this
Checklist) that have requirements 3. PLUS, ask the questions on
that this process must follow. List the Universal Items Checklist
what these ISO requirements are that apply to the process.
that this process must follow.
Check these items during the 4. AND, records should provide
audit. evidence that what was to be
You will interview the person(s) done was done and that
who performs this process. requirements are met.

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file: audit by process method Rev 2-20-09.pdf