8.2.7 Internal Audit Interpretation - Defining Status and Importance

#11
tomvehoski said:
I have always read the annual requirement as meaning the schedule has to be updated at least annually, not that every area has to be audited annually.
Yep, my thinking exaxtly. :agree:
 
Elsmar Forum Sponsor
S

SteelWoman

#12
We may get blown out of the water on this, but our internal audit procedure does have us auditing "according to an annual plan," but we give ourselves 18 months to cover the entire QMS. Rationale: In performing our first couple of "process audits" it became clear it was taking longer to accomplish than an old QS procedure-type audit. So we do "schedule them according to an annual plan" - we have a 12 month "quality plan" that shows when we audit what, but we also give ourselves 18 months to cover the entire QMS.

This flew by our Readiness Evaluation with one question from the auditor for clarification.... no news is good news?
 
#13
SteelWoman said:
We may get blown out of the water on this, but our internal audit procedure does have us auditing "according to an annual plan," but we give ourselves 18 months to cover the entire QMS. Rationale: In performing our first couple of "process audits" it became clear it was taking longer to accomplish than an old QS procedure-type audit. So we do "schedule them according to an annual plan" - we have a 12 month "quality plan" that shows when we audit what, but we also give ourselves 18 months to cover the entire QMS.

This flew by our Readiness Evaluation with one question from the auditor for clarification.... no news is good news?
I would tend to think that this would not be a problem. the main reason being that you considered things and developed your plan. Because your 18 month schedule was not developed on a whim, but on thoughtful reflection on your needs, it should be okay.
 

bpritts

Involved - Posts
#16
I don't have my book handy, but memory tells me that there is a Daimler
Chrysler C.S.R. that says the entire quality system must be covered
annually. One might infer that if a customer felt the need to create this
requirement, then the underlying standard must not require the full annual audit.

Another brief perspective: We use a "layered" philosophy. We do 1 full
system audit at a 30,000 ft level (to be candid, it is sometimes superficial).
Then we do detailed process audits (at a micro level-- e.g. 1 operation on 1
part) on a very frequent basis. We schedule the detailed audits based on
such things as new job launches (every new job gets process audits within 30 days); customer complaints (sometimes we do multiple-- a process audit right away, then another to verify the CAR); sometimes just because the job is important (high $ or sensitive customer). The systems audit meets the expectation of a full annual coverage, while the detailed process audits vary
a lot based on what's happening (status and importance.) We stumbled into
this approach in our QS implementation and it has carried forward to TS.

Brad
 
D

Dave.C

#17
That's an interesting approach Brad, and thanks to everyone who has posted on this topic, its been very helpful.

Here's the clarification I received from the CB...

"In response to your question, the audit programme for TS 16949
represents the minimum level of auditing that should be carried out.
Any subsequent or additional audits on top of that would be on the basis
of Status, Importance and results of previous audits as covered in 8.2.2
of ISO 9001:2000"

This SEEMS to confirm that they would expect entire QMS to be covered in 12 months (although it doesn't exactly say that, so I've gone back to them to be more specific about this.)

One thing is clear - an annual plan is a requirement! How much it covers in that period is open to interpretation.
 
#18
bpritts said:
I don't have my book handy, but memory tells me that there is a Daimler
Chrysler C.S.R. that says the entire quality system must be covered
annually. One might infer that if a customer felt the need to create this
requirement, then the underlying standard must not require the full annual audit.


Brad
This is why I stated that CSRs may place additional requirements. As far as your system, it seems to look at the QMS at different angles, and altitudes, which ain't bad.



Dave C said:
"In response to your question, the audit programme for TS 16949
represents the minimum level of auditing that should be carried out.
Any subsequent or additional audits on top of that would be on the basis
of Status, Importance and results of previous audits as covered in 8.2.2
of ISO 9001:2000"
That still really doesn't answer the question (in my mind). "...the audit programme for TS 16949 represents the minimum level of auditing..." just takes us back to the specification of a "yearly" plan. "Any subsequent or additional audits on top of that would be on the basis..." kinda suggests they are expecting the entire system to be audited within a calendar year, but they still have not laid out the requirement.
 
Thread starter Similar threads Forum Replies Date
P Internal Audit Reports reviewed by management? 21 CFR 820.22 Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Q Interpretation of 8.2.2.4 Internal Audit Plans in ISO TS 16949 IATF 16949 - Automotive Quality Systems Standard 3
T ISO/TS 16949:2009 Internal Audit Requirements - Your Interpretation Internal Auditing 31
F Cl 8.2.2 on Internal audit - Interpretation of Status and Importance General Auditing Discussions 4
J 8.2.2.4 Internal Audit plans - Need an interpretation Internal Auditing 1
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 7
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
salaheddine96 Internal audit planning Internal Auditing 2
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Internal Auditing 1
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 12
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
S Internal audit discrepancy - We missed a few audits that were scheduled Internal Auditing 12
Raffy ISO 14001 9.2.2 Internal Audit Programme Content Internal Auditing 10
N Internal Audit Schedule – Who gets to set the schedule? Internal Auditing 16
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
G Non Conformance During ISO 9001 Audit - Not All Internal Audits Completed General Auditing Discussions 19
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
T Internal Audit Schedule when Hiring Out Internal Auditing 7
D ISO 9001:2015 Internal Audit Training Advice Internal Auditing 10
M Internal audit consultant ISO 13485 (English speaker) Consultants and Consulting 3
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
F Internal Audit - Procedure example Internal Auditing 5
C Internal Audit - Process Clause Matrix / Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 7
CPhelan Internal audit - Combine similar nonconformities in one or keep separate? Internal Auditing 6
M Internal Audit Plan in Retail Internal Auditing 10
D Management of NC after internal system audit IATF 16949 - Automotive Quality Systems Standard 7
A Purchasing - Internal Audit Questions Internal Auditing 8
N Comprehensive Compliance Matrix for Internal Audit Checklist Other Medical Device Regulations World-Wide 1
W Where to begin with an ISO 9001:2015 internal audit Internal Auditing 13
D Internal audit forms or checklists for a medical/veterinary laboratory General Auditing Discussions 5
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
E ISO 9001:2015 - Internal Audit Plan Clauses General Auditing Discussions 8
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1

Similar threads

Top Bottom