Not having an internal audit during the year

Adriana42

Registered
:confused:Hello : I about to have my last re certification audit under ISO 9001:2008 and I didn't have an internal audit due to lack of resources , how can this affect my results ?
Thanks in advance .
:truce::truce:
 

Randy

Super Moderator
What does your internal audit program say is "periodic"? Odds are you're going to be in conflict with your audit program requirements, possibly the failed in your contract obligations with CB, and you've opened yourself up to possibly 1 if not 2 or more serious findings of nonconformity using language similar to this below.

1 - No internal audit

2 - Lack of adequate resources to "maintain" the management system effectively

3 - Failure to effectively maintain the management system per policy commitment

Outcome? Lack of recommendation for continued certification

This subject brings into question the actual commitment of your senior management and would cause me as an auditor to take a harder look (if the audit continues) at other areas that could be effected by lip service fulfillment actions of a QMS.
 
L

locutus

What Randy said. You will be having a difficult certification audit if you can not provide evidence of doing at least some internal audits. Most expectations is this is done at least annually, but as Randy states, what does your procedure say - as you might be in nonconform with your own procedure.
 

AndyN

Moved On
:confused:Hello : I about to have my last re certification audit under ISO 9001:2008 and I didn't have an internal audit due to lack of resources , how can this affect my results ?
Thanks in advance .
:truce::truce:

Experience shows you're going to get a minimum of 1 Major - for not implementing internal audits. Of course, this will likely to lead to others, for example Management Review (because one of the inputs was missing) and, no doubt because audits weren't done, there will be non-conformities with the various processes, because things have changed in a year.

I'd be interested to know why resources aren't being put behind your internal audits...
 

Sidney Vianna

Post Responsibly
Leader
Admin
While I agree with the previous posters about what should happen, especially when the problem is assigned to lack of resources, anecdotal evidence from this very forum shows that some less than competent external auditors would give this a pass; especially the ones that work for unaccredited and pseudo-accredited CB's.

In depth assessment of the internal audit process effectiveness is something that many CB auditors fail to perform.

Sadly, the norm for most organizations that "comply" with ISO 9001 and other ISO 9001-based standards is to have an internal audit process that adds little business value, from the leadership's perspective. If the top management of an organization felt they derived business benefits from internal audits, they would ensure resources were provided and demand it's effective deployment. As it is, for most organizations, internal audits are a meaningless exercise.
 
Last edited:

Big Jim

Admin
While I agree with the previous posters about what should happen, especially when the problem is assigned to lack of resources, anecdotal evidence from this very forum shows that some less than competent external auditors would give this a pass; especially the ones that work for unaccredited and pseudo-accredited CB's.

In depth assessment of the internal audit process effectiveness is something that many CB auditors fail to perform.

Sadly, the norm for most organizations that "comply" with ISO 9001 and other ISO 9001-based standards is to have an internal audit process that adds little business value, from the leadership's perspective. If the top management of an organization felt they derived business benefits from internal audits, they would ensure resources were provided and demand it's effective deployment. As it is, for most organizations, internal audits are a meaningless exercise.

Those would be the same companies that treat their certification as a thorn in their side and intend to do as little as possible for everything concerning it. It is wise to distance yourself from them. You will sleep better at night and have lower blood pressure.
 
Q

QAMTY

For sure you'll face problems,but ....Maybe you have sufficient to time to run an internal audit before the final audit take place.
 

AndyN

Moved On
For sure you'll face problems,but ....Maybe you have sufficient to time to run an internal audit before the final audit take place.

It's not just about doing an audit. What about taking corrective actions, and conducting a management review. A review's not much use without internal audit results...
 
Q

QAMTY

If planned properly, it may comply with everything, the question is, what is the timeframe to carry out all the tasks?
 

pkost

Trusted Information Resource
You could also raise your own non conformance, investigate why it happened and then implement a corrective action plan

This could be used as a gesture that you're not completely blind to what has happened. Best do something about it now instead of sitting in your re-cert audit and saying to the auditor "yeah, we know thats a problem but we haven't done anything about it"
 
Thread starter Similar threads Forum Replies Date
C Objective Evidence of Internal Auditors having Audit Clause 4.1. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
MarilynJ6354 Observed Audit Behavior - Internal auditors having lunch with the auditees Internal Auditing 32
U QS 9000 Audit - Trainer of internal auditors not having formal training QS-9000 - American Automotive Manufacturers Standard 6
J Problems with our internal auditors having a lack of motivation Internal Auditing 1
M Having Trouble Identifying KPI for Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
bobdoering Is your quality department having a "No Chili" day? Funny Stuff - Jokes and Humour 2
H Still having trouble as to what equipment falls under 8.5.1.1 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
NDesouza No Quality Professional vs Having a Quality Professional Benchmarking 24
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
O Inspecting paint and having workable standards in the supply chain Supplier Quality Assurance and other Supplier Issues 1
P Received a minor for not having good measureables/goals. Need help with KPIs. IATF 16949 - Automotive Quality Systems Standard 52
N GDP - Having to provide a reason when writing N/A? ISO 13485:2016 - Medical Device Quality Management Systems 1
O How do reduce the risk of suppliers having similar problems? Supplier Quality Assurance and other Supplier Issues 4
D Having got ISO 13485:2016 are you dropping ISO 9001? ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Partial non applicability of ISO 9001 Cl. 7.1.5 (not having services)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Having Fun While Learning ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Having a hard time closing CAR/ PAR Nonconformance and Corrective Action 13
M Justification for Not Having a Validation Plan for a Critical Process ISO 13485:2016 - Medical Device Quality Management Systems 4
I Not having "effectiveness" in the Quality Policy ISO 13485:2016 - Medical Device Quality Management Systems 8
U Root Cause for a Form not having all info (traceability standard and the gage number) Problem Solving, Root Cause Fault and Failure Analysis 14
M How to compare 2 independent samples having 3 factors 3 levels Statistical Analysis Tools, Techniques and SPC 5
W Thoughts on having Safety Shower in ISO Class 7 Cleanroom ISO 13485:2016 - Medical Device Quality Management Systems 5
T Customer Escape of a part having features reversed 180 degrees Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
ScottK Is anyone else having problems uploading Proprietary Names into the DRLM? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
K Calibration Standards - Master weight having more tolerance than our gram scale General Measurement Device and Calibration Topics 3
D Having trouble with corrective action on external audit nonconformance Nonconformance and Corrective Action 8
S Minor NC for Not Having Management Review When Scheduled Management Review Meetings and related Processes 12
B Example of Production Process Change having Significant Consequences AS9100C 7.5.1.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
C Can a Company get away with not having Employees Trained to the Processes they use? Training - Internal, External, Online and Distance Learning 2
J DOE Analysis Experiment, 5 factors, 4 factors having 3 levels, and 1 factor having 5 Using Minitab Software 38
B Having trouble writing a directive (procedure) that points to the right place ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
J Ever heard of having a Controlled SOP template? Document Control Systems, Procedures, Forms and Templates 12
J What is the advantage of having an NCA 3800 Quality Certificate Various Other Specifications, Standards, and related Requirements 3
N Benefits of having an EDMS in a Construction Company Various Other Specifications, Standards, and related Requirements 5
S CE Label having the indication for the applied part EU Medical Device Regulations 7
Marc Florida Professor Arrested for Having a "Suspicious" Bagel on a Plane Travel - Hotels, Motels, Planes and Trains 14
F Reliability of a System - Estimation of R(t) having constant failure rate "Lambda" Reliability Analysis - Predictions, Testing and Standards 2
D What is the basis for having 1 or 6 Quality Manuals? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Having quality in your resume in today's economy. Imported Legacy Blogs 3
C What is the Purpose of or Requirement for having a Gage Glossary? IATF 16949 - Automotive Quality Systems Standard 2
I Not having Training Records for Documentation Changes - ISO 13485 Clause 4.2.3 Document Control Systems, Procedures, Forms and Templates 22
S Feasibility of having one Quality Manual that documents 2 businesses? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ajit Basrur Anyone having procedure on "Handling Regulatory Audits" ? US Food and Drug Administration (FDA) 2
somashekar Optical epoxy for LED having good thermal shock resistance. Manufacturing and Related Processes 2
Q 510k for Exempt Class I Medical Device - Industry Advantage to having a 510k Approval 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
L Having faith in your Layered Process Auditors - Pencil whipping audits Process Audits and Layered Process Audits 8
P Having only influential control for some Legal needs. Miscellaneous Environmental Standards and EMS Related Discussions 2
S What are the consequences of having an expired ISO 9001:2000 Certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J Advantage of having 2 marks - RvA and ANAB, for example Registrars and Notified Bodies 5
L Objectives: Measurable or having a tangible value? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom