CB and customer audits considered as internal audits?

DarisS

Starting to get Involved
#1
Hello,
Can we consider CB or customer audits as internal audits? Both ISO 9001 or 13485 are just stating that we must conduct audits but there is no mention that the audits must be done by our own employees. Therefore, knowing that my CB and some customers are auditing my company once a year, why can I not consider their work as equivalent as any other "internal" audit?
And if this is not acceptable, I'm wondering where it is mentionned on the ISO standards?
Thanks
Daris
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
Hello,
Can we consider CB or customer audits as internal audits? Both ISO 9001 or 13485 are just stating that we must conduct audits but there is no mention that the audits must be done by our own employees. Therefore, knowing that my CB and some customers are auditing my company once a year, why can I not consider their work as equivalent as any other "internal" audit?
And if this is not acceptable, I'm wondering where it is mentionned on the ISO standards?
Thanks
Daris
Please don't even try that silly game, it's been done before with disastrous results..... Where is this mentioned?

9.2.1 The organization shall conduct internal audits at planned intervals to provide information on
whether the quality management system:
a) conforms to:
1) the organization’s own requirements for its quality management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.

You're the "ORGANIZATION", not me, not your customer not anyone but YOU!!!!

Yep there's no mention about employees doing the audit or anything like that, but if you're thinking about this game you as so far wrong you'll go over the edge fast.
 

Johnny Quality

Quite Involved in Discussions
#3
Hello,
Can we consider CB or customer audits as internal audits? Both ISO 9001 or 13485 are just stating that we must conduct audits but there is no mention that the audits must be done by our own employees. Therefore, knowing that my CB and some customers are auditing my company once a year, why can I not consider their work as equivalent as any other "internal" audit?
And if this is not acceptable, I'm wondering where it is mentionned on the ISO standards?
Thanks
Daris
Daris,

According to ISO 9000:2015 Quality management systems — Fundamentals and vocabulary as stated here, under section 3.13 note 2 "An audit can be an internal audit (first party), or an external audit (second party or third party), and it can be a combined audit (3.13.2) or a joint audit (3.13.3)."

Audits from your customer are classified as second party audits (parties interested in your organization) and audits from your CB are classified as third party audits. Neither of these count as internal audits so you cannot classify either as an internal audit.

First party audits do not need to be done by the organizations employees as they can be outsourced to contractors in 9001, I am unsure if this is still valid for 13485.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#5
Agree with all of the above folks. If someone has trouble with understanding this one, it's a bad sign.
 

DarisS

Starting to get Involved
#7
Thanks for your feedback Randy, Johnny, Sidney, Mike and Jim. Seems I pinched a sensitive point...:notangel:

I agree that my question was a bit provocative... I've been in quality for more than 30 years so I know the job and I have to admit that I'm just bored by internal audit (as you are more than often identifying the same findings once every two to three years) and I was looking at other ways to get valuable inputs and as a matter of fact, CB audits are bringing tons of valuable inputs that have the same flavor than "internal" audits. And if I am taking Sidney's words, when a CB is auditing my company, he is doing an "internal" audit of my organization and not a supplier audit or whatever... And as Johnny wrote, first party audits do not need to be necessarily done by your own staff, you can hire a consulting company to carry them. So why CB or customer inputs would not cover some of your "internal" audits. Let us be pragmatic, a customer auditing your non-conforming product management will do an equivalent or even better job than your own auditor team.
Back to Johnny inputs, I agree that the ISO 9000:2015 is clarifying what is a first, second and third party audit, but the ISO 9001 and 13485 are then not addressing how do you "value" those second and third party audits.
I know so many companies that are doing internal audits just to fulfill the ISO requirements and "please" the CB auditors that I feel the need to shake the basement.
PS: I'm not an English-speaking person, so my words may be too simple to express my mood.
And thanks again for your comments and reactions.
Daris
 

Johnny Quality

Quite Involved in Discussions
#8
I have to admit that I'm just bored by internal audit (as you are more than often identifying the same findings once every two to three years)
Would you say that the root cause is the scope of internal audits, the lead auditor planning the audits, the auditor or something else?
 

DarisS

Starting to get Involved
#9
Would you say that the root cause is the scope of internal audits, the lead auditor planning the audits, the auditor or something else?
Not sure about the reason...
It may be that the internal auditors have done so many audits and they are not anymore digging or questioning the same way as it was at the beginning with the full boost of enthusiasm that you have when you are new to audits. I can feel it when reading the audit reports, I am not anymore seeing interesting inputs but always the same old stories, with procedure deviation, obsolete documentation, missing information on traceability, etc. no big deals, only the common human errors that are not significantly impacting your quality system.
Other example, when auditing, let's say the Management review process, there is not that much of a challenge the auditor is taking. It will just tell you that "yes there is a management review process, yes it was correctly performed for the last period, and yes, it contains the required reviews, and yes all the inputs and outputs are present." Then few month later I get the same evaluation by the CB. And you then see my point... Why did I waste the internal auditor time to get the exact same input from the CB two month later? Not that much motivation beneath...
 

Randy

Super Moderator
#10
1st...Don't ever apologize for your language and especially for not speaking English because you seem to be making your point better than many college trained Americans

2nd...Maybe you need to freshen up your audit process, if you're using some type of dribble ridden, pre-programed, regugitated checklist toss the stinking thing. Give your auditors one of your procedures, flowcharts, SOP, workaids or whatever you use and say "Prove that we do it to the letter" and for Pete's sake take ISO 9001 or whatever out of their hands, lay it on a table and drive a nail into it, using that document over and over again is nothing but a total rehash of the Gap Analysis you should have done years ago.
 
Last edited:
Thread starter Similar threads Forum Replies Date
S Obligation to accept customer audits? IATF 16949 - Automotive Quality Systems Standard 23
Genofear Customer wants to audit our supplier audits - seems inappropriate General Auditing Discussions 11
M Utilizing ISO and Customer Audits for Internal Audits Internal Auditing 14
S Excipient Manufacturers - Supplier Risk Assessments when they refuse Customer Audits Supplier Quality Assurance and other Supplier Issues 5
P CSR (Customer Specific Requirements) in TS 16949 Audits - Always required? IATF 16949 - Automotive Quality Systems Standard 27
J Audit Programme - Include CB Audits, Customer Audits, Supplier Audits? General Auditing Discussions 18
ScottK Using Customer Audits as part of the Internal Audit Plan for ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
P Can External Audits by Customer be treated As Internal Audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
M Silly customers - Customer On-Site Audits US Food and Drug Administration (FDA) 28
I How to measure internal auditees' performance during customer audits? IATF 16949 - Automotive Quality Systems Standard 7
ScottK How does your organization react to customer audits? General Auditing Discussions 16
N To Register to ISO 9001 or Not To Register? Will customer audits be reduced if we do? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Customer Satisfaction and Internal Audits Internal Auditing 3
A Internal audits on CSR (Customer Specific Requirements) - Look at Ford's Behemoth Internal Auditing 1
Raffy Internal Audit vs. Customer Audits - Can we count Customer Audits as IAs? Internal Auditing 25
A Should Customer Complaints trigger Internal Audits? Customer Complaints 6
J Customer Audits and Guides General Auditing Discussions 13
S Rude Customer Auditor General Auditing Discussions 18
M Customer Specific Requirements - Packaging Spec IATF 16949 - Automotive Quality Systems Standard 10
D Automotive Customer asking for ISO 14001 Certification from suppliers ISO 14001:2015 Specific Discussions 3
M Signed PSW directly to End customer, Tier 1 wants their own PPAP IATF 16949 - Automotive Quality Systems Standard 6
D Customer requirements on specific standards Various Other Specifications, Standards, and related Requirements 5
Crimpshrine13 Customer Scorecards - Missing Scorecard from one Customer IATF 16949 - Automotive Quality Systems Standard 27
B Customer Preference Testing Customer and Company Specific Requirements 2
T No Customer Response to an SCR Manufacturing and Related Processes 2
D Customer Specific Requirements / Customer Requirements for Indirect Customers IATF 16949 - Automotive Quality Systems Standard 10
H Customer Specific Change in a SaaS SAMD IEC 62304 - Medical Device Software Life Cycle Processes 1
B Put on escalation by customer? is there a requirement to notify registrar? IATF 16949 - Automotive Quality Systems Standard 6
P 7.5.10 Customer property - applies to leased/rented equipment? ISO 13485:2016 - Medical Device Quality Management Systems 10
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
R Cpk demands from automotive customer Capability, Accuracy and Stability - Processes, Machines, etc. 8
briteme4 Customer Requests FAI on Tooling Fixture AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Suggestions for Ishikawa for hyperdetailed customer - plastic molding automotive parts Nonconformance and Corrective Action 9
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 3
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
M Reduce occurrence rating based on the PMS data and customer complaint data ISO 14971 - Medical Device Risk Management 2
M IATF16949 Clause 9.1.2.1e - Customer notification related IATF 16949 - Automotive Quality Systems Standard 4
G Too many customer complaints Customer Complaints 16
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
J Customer Complaint & SCAR, false data Nonconformance and Corrective Action 14
S Annual Inspection Layout - Based on Customer print ? IATF 16949 - Automotive Quality Systems Standard 8
G Risk of stopping your customer's line IATF 16949 - Automotive Quality Systems Standard 4
S Calibration/Verification of customer fixtures IATF 16949 - Automotive Quality Systems Standard 6
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
G Bad Parts cause Customer line stop IATF 16949 - Automotive Quality Systems Standard 13
O IATF 16949 News Ford Motors Customer Specific Requirements Update - Nov 2020 IATF 16949 - Automotive Quality Systems Standard 5
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
B Retention Samples when Customer Leaves Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
M Email Template that go to a customer and then get returned to us for RMA/Warranty Document Control Systems, Procedures, Forms and Templates 1

Similar threads

Top Bottom