Internal audit checksheet for TS 16949 that covers a complete system audit?

M

micheal

#1
Can anyone provide an internal audit checksheet for TS 16949 that covers a complete system audit? I have looked at most available threads and cannot seem to find. Any help would be appreciated.

:thanx: Micheal
 
Elsmar Forum Sponsor

Helmut Jilling

Auditor / Consultant
#3
micheal said:
Can anyone provide an internal audit checksheet for TS 16949 that covers a complete system audit? I have looked at most available threads and cannot seem to find. Any help would be appreciated.

:thanx: Micheal

There are not many around because TS is not supposed to be audited to a checklist of the requirements. The TS Rules require that the system audits be performed using a process approach, using those processes you defined for your system. See cl 4.1 for more info.

The clause based checklist, if used at all, can only be used as a gap analysis when setting up the system.
 

Caster

An Early Cover
Trusted Information Resource
#5
OK for desk audit?

hjilling said:
There are not many around because TS is not supposed to be audited to a checklist of the requirements. The TS Rules require that the system audits be performed using a process approach, using those processes you defined for your system. See cl 4.1 for more info. The clause based checklist, if used at all, can only be used as a gap analysis when setting up the system.
Another use is what I call a systems or desk audit to verify that the system as written continues to meet TS requirements.

We just completed our first (now to be annual) system audit. It did identify some areas where our system had drifted away from meeting the requirements as revisons were made. And it also showed areas where our system had never met the requirements (despite being on our second surveillance).

However, you are correct, a clause based checklist can not be used to meet the intent of a process audit.
 
#6
Re: OK for desk audit?

Another use is what I call a systems or desk audit to verify that the system as written continues to meet TS requirements.

We just completed our first (now to be annual) system audit. It did identify some areas where our system had drifted away from meeting the requirements as revisons were made. And it also showed areas where our system had never met the requirements (despite being on our second surveillance).

However, you are correct, a clause based checklist can not be used to meet the intent of a process audit.
How did you go about conducting your system audit? We are in the process of obtaining our TS certification and understand that we must conduct process audits and system audits. Unfortunately, we are not real clear on the difference between the two, more specific, what constitutes a system audit. - Thanks.
 

Helmut Jilling

Auditor / Consultant
#7
Re: OK for desk audit?

How did you go about conducting your system audit? We are in the process of obtaining our TS certification and understand that we must conduct process audits and system audits. Unfortunately, we are not real clear on the difference between the two, more specific, what constitutes a system audit. - Thanks.

The TS Rules provide some guidance on this. Basically, both must be performed in a process approach.

Your quality system is defined as a series of processes (cl. 4.1). These must be scheduled and audited to the process approach. The manufacturing process audits must also be audited to a process approach. But, typically, those are a detailed walk through of the control plan.
 

Helmut Jilling

Auditor / Consultant
#9
Hi micheal,

I tried to borrow (actually plagiarized :eek: ) some of the Covers ideas and developed one for myself.

Hope this would help.

tony s
Looks pretty good to me. You can also make a list of particular questions for each process, but you can't stop there. It takes this kind of process thinking to go with it. And, audit the linkages to other processes and support processes.
 

tony s

Information Seeker
Trusted Information Resource
#10
Thanks hjiling,

Actually, I'm still trying to completely understand the process approach auditing. When you said "It takes this kind of process thinking to go with it", I'm a bit confused or worried that I still have a lot to learn.:frust:

And, audit the linkages to other processes and support processes.
Question: Isn't auditing each process input and output the same with auditing the linkages?:)

Hope you can give some help in clarifying this. Thanks in advance.

tony s
 
Thread starter Similar threads Forum Replies Date
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
S Internal Audit - Risk and Opportunity (ISO 9001:2015 ) Internal Auditing 1
F API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits. Oil and Gas Industry Standards and Regulations 22
Ashland78 IATF 16949 Internal Audit Checklist Manufacturing and Related Processes 11
Ed Panek Root Cause CAPAs from internal audit ISO 13485:2016 - Medical Device Quality Management Systems 16
K Student wanting Case Study about Internal Audit Report Internal Auditing 1

Similar threads

Top Bottom