Informational What is the purpose of Internal Audits?

Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#13
Am I over thinking this or stating the obvious?
Internal audits are one component of the "check step" in the PLAN-DO-CHECK-ACT cycle that all ISO Management System Standards are modeled after. You have already received excellent responses on why, but, as also alluded to, you should consider the how.

Unfortunately, the overwhelming majority of organizations certified out there do as little as they can, when it comes to internal audits. They don't see the value, the benefit and, because of that, they invest very little qualifying the personnel performing as internal auditors and dedicate as little time as possible when planning, performing and reporting the internal audits. So, for them, the why of internal audit is: to pass the external audit.

It has been said ad nauseum, before. If internal audits were performed in the proper way, with properly qualified, competent people, they would be one of the most effective improvement tools any organization management could think of. Sadly, for the most part, they are a waste of time, effort and opportunities.
 
#14
To take Roxane's thoughts even further, it's tempting to consider internal audits in isolation and, hence, to miss the whole point of doing them - which is to provide an input to managements' review of the QMS (in a manner they understand). So, before we talk about doing internal audits (and it's NOT to prepare for the external audit as I mentioned previously) you have to answer WHY do Management Review?
 

TPMB4

Quite Involved in Discussions
#15
Internal audits are one component of the "check step" in the PLAN-DO-CHECK-ACT cycle that all ISO Management System Standards are modeled after. You have already received excellent responses on why, but, as also alluded to, you should consider the how.

Unfortunately, the overwhelming majority of organizations certified out there do as little as they can, when it comes to internal audits. They don't see the value, the benefit and, because of that, they invest very little qualifying the personnel performing as internal auditors and dedicate as little time as possible when planning, performing and reporting the internal audits. So, for them, the why of internal audit is: to pass the external audit.

It has been said ad nauseum, before. If internal audits were performed in the proper way, with properly qualified, competent people, they would be one of the most effective improvement tools any organization management could think of. Sadly, for the most part, they are a waste of time, effort and opportunities.
I completely agree with everything you have said. I'm the guy doing it with zero training so I'm very biased! If I ask stupid questions it's because I'm practically self taught. They don't seem stupid questions to me because of this. Despite this I'm doing my best.

As to my question here. Our external auditor has transitioned us to the new version of 9001 following improvements to our system that I arranged to put in place and documented. The 9001 2015 isn't changing anytime soon, auditing our system and what we do should cover the aspect of conforming to the standard since it's already been audited against the standard by the external. The only parts needing auditing against the standard directly are any changes or improvements made (made by internal audit or by other internal improvement process). Auditing against 9001 is inherent but you don't specifically need to actively consider it. Not explaining it well perhaps.

BTW I'm in the process of reviewing personal options by producing a portfolio of experience / cpd. I want to document what I know so I can sort my own weaknesses through courses because my employers won't do it. Can I log this forum as cpd??;)
 

Ninja

Looking for Reality
Staff member
Super Moderator
#17
so they don't get found by the external auditors
That would be pretty near the bottom of my list...:lmao:
Perhaps I wasn't clear that I consider a customer to be an external audit...
I'd much rather have an internal auditor find "stuff-needin'-fixin' " than to have a customer find it.

...or did you just mean literal "dead bodies" :censored:
 

Ninja

Looking for Reality
Staff member
Super Moderator
#19
Fair 'nuff...(though I never once got written up by a customer...likely due to that curmudgeon internal auditor I had)...but if a customer is gonna write you up, at least make them work for it...

"Customer failed to produce a written and approved work instruction on the method by which documents are signed for approval."
"Customer served coffee to the visiting audit team, but failed to produce the procedure by which coffee should be made. Since said coffee was served to a customer, it is considered a product provided (shipped and delivered) to the customer and as such should have a documented manufacturing process, PFMEA, DFMEA and control plan. None of these were in evidence. Coffee supplier is not listed on the approved suppliers list."
 
Last edited:

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#20
Internal audits are one component of the "check step" in the PLAN-DO-CHECK-ACT cycle that all ISO Management System Standards are modeled after. You have already received excellent responses on why, but, as also alluded to, you should consider the how.

Unfortunately, the overwhelming majority of organizations certified out there do as little as they can, when it comes to internal audits. They don't see the value, the benefit and, because of that, they invest very little qualifying the personnel performing as internal auditors and dedicate as little time as possible when planning, performing and reporting the internal audits. So, for them, the why of internal audit is: to pass the external audit.

It has been said ad nauseum, before. If internal audits were performed in the proper way, with properly qualified, competent people, they would be one of the most effective improvement tools any organization management could think of. Sadly, for the most part, they are a waste of time, effort and opportunities.
The only thing missing in this statement is the support of management. The best internal auditor gets nowhere without top management buy-in to the effort and intent.
 
Thread starter Similar threads Forum Replies Date
A Auditor suggested company find a higher purpose for Internal Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Records required for ISO 9001 clause 7.1.5.1 - Fitness for purpose of the monitoring and measurement resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A A purpose of a Stage 1 audit - Off site document review Registrars and Notified Bodies 3
A Audit purpose - case study - What is the role of SQE in such case? General Auditing Discussions 3
A True purpose of doing EST (Electrical Safety Test) on medical device Other Medical Device Related Standards 3
K QMS Improvement - Analyze the systemic weaknesses of the QMS for improvement purpose Quality Tools, Improvement and Analysis 6
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
SK13485 Can a literature alone be used for the purpose of Clinical Evaluation of a device? EU Medical Device Regulations 6
E IATF 16949 Cl. 7.1.5.1 - Documented information as evidence of fitness for purpose IATF 16949 - Automotive Quality Systems Standard 3
R Auditing Fitness of Purpose for Monitoring and Measuring Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Are dermal fillers & PDO sutures for aesthetic purpose under CE MDD? EU Medical Device Regulations 6
somashekar Electronic data Back-up procedure, for Medical device QMS and regulatory purpose. ISO 13485:2016 - Medical Device Quality Management Systems 4
P Purpose of calculating Ta, Tb & R Square in Linearity Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
P Purpose of calculating Uncertainty value in calibration study Measurement Uncertainty (MU) 5
Q IEC 60601 for Non-Medical Research Purpose Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D UV Absorption Test - What is it's purpose and what specifically is it looking for? Other Medical Device Related Standards 9
A ISO/IEC 20000 Toolkit For Academic Purpose IT (Information Technology) Service Management 6
L What is, and the purpose of, ISO STATS recording ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
x-files Hardcopy and Electronic Forms for same purpose vs. Naming and Numbering System Document Control Systems, Procedures, Forms and Templates 1
N How to qualify (IQ, OQ, PQ) a multi-purpose equipment ? Imported Legacy Blogs 1
V The Purpose of Basic Dimensions on Prints APQP and PPAP 6
Q Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards Philosophy, Gurus, Innovation and Evolution 12
J How to qualify (IQ, OQ, PQ) a multi-purpose equipment ? Qualification and Validation (including 21 CFR Part 11) 5
S Logo Marking for Marketing purpose - ISO 9001, ISO 14001 and OHSAS 18001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P What is the latest version of ISO 10021 used for Certification purpose? Other ISO and International Standards and European Regulations 3
N Export & Import of Unapproved Device in USA for Service Purpose Only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Purpose of the Quality Manual for an Organisation Quality Management System (QMS) Manuals 4
M TS 16949 Clause 7.5.1.8 - Special-Purpose Tools or Measurement Equipment IATF 16949 - Automotive Quality Systems Standard 2
A FDA: Label Requirements for General Purpose Reagents IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A What is the purpose of using AQL (Acceptable Quality Level) for Sampling? AQL - Acceptable Quality Level 3
S What is the purpose of ON HOLD Labels Food Safety - ISO 22000, HACCP (21 CFR 120) 5
Q How to write Statement of Purpose for a Law School Admission Career and Occupation Discussions 9
C FDA Approval Process for Device that can also be used for Veterinary Purpose 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R Can some one share JIS B7502/7507 or DIN862 with me for study purpose? General Measurement Device and Calibration Topics 2
C What is the Purpose of or Requirement for having a Gage Glossary? IATF 16949 - Automotive Quality Systems Standard 2
P What is the purpose and use of Chart Stickers Labels? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Purpose of using different Distributions to solve Reliability Problems? Reliability Analysis - Predictions, Testing and Standards 2
Z CMM Measuring Instruction - Example needed for translation purpose Document Control Systems, Procedures, Forms and Templates 17
L Please share some practical SPC exercises for training purpose Statistical Analysis Tools, Techniques and SPC 4
thisby_ Intended Use vs. Intended Purpose vs. Intended by the Manufacturer - Doubts ISO 13485:2016 - Medical Device Quality Management Systems 9
S What is the purpose of Critical to Quality tree (CTQ)? Six Sigma 2
Q Using Class 3 used Electronic Devices for Training purpose ISO 13485:2016 - Medical Device Quality Management Systems 1
R Copy of TS16949:1999 for reading purpose IATF 16949 - Automotive Quality Systems Standard 7
R What is the purpose of Benchmarking? Benchmarking 5
K Process Tailoring - What is the purpose of process tailoring? Software Quality Assurance 12
U What is the purpose of a Software Test Plan? Software Quality Assurance 7
P Six Sigma Case Studies and Exercise material for practice purpose. Six Sigma 12
Z Using Different Forms For One (same) purpose Document Control Systems, Procedures, Forms and Templates 2

Similar threads

Top Bottom